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O’Neill KG, Buscho SE, Elmir Digbeu BD, Dezeeuw Z, Merkley KH, Gupta PK. Unequal Referral Patterns to Ophthalmology Subspecialists Based on Race and Ethnicity in Diabetes Mellitus: A Retrospective Analysis. Clin Ophthalmol 2025; 19:1609-1616. [PMID: 40401037 PMCID: PMC12094482 DOI: 10.2147/opth.s519979] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/07/2025] [Accepted: 04/23/2025] [Indexed: 05/23/2025] Open
Abstract
Purpose Previous research has shown that racial disparities exist regarding the prevalence of and associated vision loss from diabetic retinopathy. Unfortunately, little is known about potential racial and ethnic disparities of diabetic eye exam referral patterns by primary care providers. Understanding referral patterns to ophthalmic specialists is key to understanding the steps needed to prevent progression of this vision-threatening condition, particularly in minority populations. Patients and Methods Patients who were diagnosed with type II diabetes mellitus (DM) at a tertiary medical center between 2015 and 2023 were retrospectively identified from the electronic medical record (n = 10,995). Patient demographics, comorbidities, presence or absence of ophthalmology referral, HbA1c and insulin dependence at time of referral, time from referral to first ophthalmic appointment, as well as diabetic retinopathy presence/stage at first ophthalmic exam after referral were collected. Results Of the white patients who were diagnosed with DM, 79.3% were referred for ophthalmology screening, compared to 78.55% of Hispanic patients (RR: 1.03 [95% CI: 0.92, 1.15]) and 75.75% of black patients (RR: 0.83 [95% CI: 0.74, 0.93]) (p = 0.0009). 56.38% of White patients had a HbA1c ≥ 7% at referral compared to 61.33% of Hispanic patients (RR: 1.16 [95% CI: 1.00, 1.34]) and 53.48% of Black patients (RR 0.86 [95% CI: 0.73, 1.01]) (p = 0.0004). 5.69% of referred white patients were diagnosed with diabetic retinopathy compared to 10.22% of Black patients (RR: 1.88 [95% CI 1.58, 2.23) and 10.91% of Hispanic patients (RR: 1.58 [95% CI 1.32, 1.89]) (p < 0.0001). Conclusion Black patients were less likely to receive an ophthalmology referral at the time of DM diagnosis, and Hispanic patients were more likely to be referred at a more severe HbA1c compared to white patients. Both black and Hispanic patients were more likely to be diagnosed with diabetic retinopathy at first ophthalmic appointment than white patients.
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Affiliation(s)
| | - Seth E Buscho
- John Sealy School of Medicine, University of Texas Medical Branch, Galveston, TX, USA
| | | | - Zachary Dezeeuw
- Department of Ophthalmology & Visual Sciences, University of Texas Medical Branch, Galveston, TX, USA
| | - Kevin H Merkley
- Department of Ophthalmology & Visual Sciences, University of Texas Medical Branch, Galveston, TX, USA
| | - Praveena K Gupta
- Department of Ophthalmology & Visual Sciences, University of Texas Medical Branch, Galveston, TX, USA
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Weltman MR, Lavenburg LMU, Han Z, Alghwiri AA, Mosslemi M, Rollman BL, Fischer GS, Nolin TD, Yabes JG, Jhamb M. Population Health Management and Guideline-Concordant Care in CKD: A Secondary Analysis of Kidney Coordinated HeAlth Management Partnership. J Am Soc Nephrol 2025; 36:869-881. [PMID: 39485493 PMCID: PMC12059108 DOI: 10.1681/asn.0000000544] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/03/2024] [Accepted: 10/28/2024] [Indexed: 11/03/2024] Open
Abstract
Key Points Implementation gaps in guideline-concordant care for CKD are associated with poor clinical outcomes. A population health management–based, multidisciplinary approach improved exposure days to sodium-glucose cotransporter-2 inhibitor and glucagon-like peptide-1 receptor agonists compared with usual care. Angiotensin-converting enzyme inhibitor/angiotensin receptor blocker in albuminuric patients and statin use was not improved, nor was BP control, glycemic control, or albuminuria testing. Background Gaps in guideline-concordant care for CKD lead to poor outcomes. The Kidney Coordinated HeAlth Management Partnership (K-CHAMP) cluster randomized trial tested the effect of a population health management intervention versus usual care on CKD progression and evidence-based care delivery in the primary care setting. Methods K-CHAMP included adults aged 18–85 years with eGFR<60 ml/min per 1.73 m2 and moderate-high risk of CKD progression who were not seeing a nephrologist. The multifaceted intervention included nephrology e-consult, pharmacist-led medication management, and patient education. In this post hoc analysis, we evaluate the effectiveness of K-CHAMP on guideline-concordant care processes (BP and glycemic control, annual albuminuria testing) and medication exposure days (angiotensin-converting enzyme inhibitor [ACEi]/angiotensin receptor blocker [ARB], moderate-high intensity statin, sodium-glucose cotransporter-2 inhibitor [SGLT2i], glucagon-like peptide-1 receptor agonists [GLP-1RA]). Given multiplicity of outcomes, Benjamini–Hochberg method was used to control false discovery rate. Results All 1596 (754 intervention, 842 usual care) enrolled patients (mean age 74±9 years, eGFR 37±8 ml/min per 1.73 m2, 928 [58%] female, 127 [8%] Black) were analyzed. After a median 17-month follow-up, intervention arm patients had significantly higher exposure days per year to SGLT2i (56 versus 32 days; relative benefit 1.72; 95% confidence interval [CI], 1.14 to 2.30) and GLP-1RA (78 versus 29 days; relative benefit 2.65; 95% CI, 1.59 to 3.71) compared with usual care in adjusted analysis. At study initiation in 2019, similar proportion of patients were prescribed SGLT2i and/or GLP-1RA in intervention and control arm (8% versus 6%, respectively; rate ratio 1.23; 95% CI, 0 to 2.99), but by 2022, prescription of these medications was significantly higher in intervention arm (44% versus 27%, respectively; rate ratio 1.63; 95% CI, 1.32 to 1.94). There was no significant difference in any process measures or exposure days to ACEi/ARB in patients with albuminuria or moderate-high intensity statin. Conclusions K-CHAMP was effective in accelerating implementation of SGLT2i and GLP-1RA but did not increase ACEi/ARB in patients with albuminuria or moderate-high intensity statin use or improve BP control, glycemic control, or albuminuria testing in individuals with CKD in the primary care setting. Clinical Trial registry name and registration number: K-CHAMP, NCT03832595 .
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Affiliation(s)
- Melanie R. Weltman
- Renal-Electrolyte Division, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
- Department of Pharmacy and Therapeutics, University of Pittsburgh School of Pharmacy, Pittsburgh, Pennsylvania
| | - Linda-Marie U. Lavenburg
- Renal-Electrolyte Division, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
| | - Zhuoheng Han
- Renal-Electrolyte Division, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
| | - Alaa A. Alghwiri
- Renal-Electrolyte Division, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
| | - Mitra Mosslemi
- Department of Epidemiology, University of Pittsburgh School of Public Health, Pittsburgh, Pennsylvania
| | - Bruce L. Rollman
- Division of General Internal Medicine, Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania
- Center for Behavioral Health, Media, and Technology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
| | - Gary S. Fischer
- Division of General Internal Medicine, Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania
| | - Thomas D. Nolin
- Renal-Electrolyte Division, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
- Department of Pharmacy and Therapeutics, University of Pittsburgh School of Pharmacy, Pittsburgh, Pennsylvania
| | - Jonathan G. Yabes
- Division of General Internal Medicine, Department of Medicine and Biostatistics, Center for Research on Heath Care, University of Pittsburgh, Pittsburgh, Pennsylvania
| | - Manisha Jhamb
- Renal-Electrolyte Division, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
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Khodabandehloo P, Fakembe P, Senga J, Shulman R, Lipscombe LL, Witteman HO, Banerjee A, Presseau J, Nakhla M, Dogba MJ, Lovblom LE, Rabasa-Lhoret R, Brazeau AS, Najam A, Cheema W, MacGibbon C, Weisman A. Social disadvantage and technology use among adults with type 1 diabetes in Quebec: A cross-sectional study using data from the Canadian T1D (BETTER) Registry. Diabetes Obes Metab 2025. [PMID: 40302106 DOI: 10.1111/dom.16426] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/20/2025] [Revised: 04/04/2025] [Accepted: 04/16/2025] [Indexed: 05/01/2025]
Abstract
AIMS We evaluated associations between social disadvantage and insulin pump and continuous glucose monitor (CGM) use among adults with type 1 diabetes (T1D) in Quebec, Canada, where public funding is available for CGM but not for insulin pumps. MATERIALS AND METHODS We conducted a cross-sectional analysis using self-reported survey data collected from April 2019 to October 2023. Primary exposures were social disadvantage indicators (Race, income, education, employment, insurance, immigration, rural/urban location). Primary outcomes were insulin pump and CGM use. Logistic regression was used to assess associations between social disadvantage indicators and the odds of insulin pump and CGM use. RESULTS Among 2380 adults with T1D, 37.4% used insulin pumps and 82.5% used CGM. Insulin pump use was lower among those with income <$80 000 (odds ratio [OR] 0.64 [95% confidence interval 0.50-0.82]), no post-secondary education (OR 0.62 [0.46-0.85]), non-White Race (OR 0.47 [0.30-0.73]) and public insurance (OR 0.47 [0.35-0.62]). CGM use was lower only among those with income <$80 000 (OR 0.61 [0.45-0.83]) and public insurance (OR 0.61 [0.45-0.83]). Odds of insulin pump and CGM use were successively lower with an increasing number of social disadvantage indicators. Insulin pump and CGM use were both associated with lower HbA1c but not severe hypoglycaemia or diabetes hospitalisation. CONCLUSIONS Social disadvantage is associated with lower uptake of insulin pumps and CGM among Quebec adults with T1D, though public funding partially mitigates disparities in CGM use. Given the benefits and increasing recommendations for automated insulin delivery, strategies to increase the uptake of diabetes technologies among socially disadvantaged individuals are required. PLAIN LANGUAGE SUMMARY Social disadvantage is linked to lower use of insulin pumps and CGM in adults with T1D in Quebec. Public funding narrows CGM disparities, but broader equity strategies are needed.
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Affiliation(s)
- Parisa Khodabandehloo
- Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Ontario, Canada
| | - Patience Fakembe
- Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Ontario, Canada
| | - Joyeuse Senga
- Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Ontario, Canada
| | - Rayzel Shulman
- Division of Endocrinology, The Hospital for Sick Children, Toronto, Ontario, Canada
| | - Lorraine L Lipscombe
- Department of Medicine, University of Toronto, Toronto, Ontario, Canada
- ICES, Toronto, Ontario, Canada
- IHPME, University of Toronto, Toronto, Ontario, Canada
- Women's College Research Institute, Toronto, Ontario, Canada
| | - Holly O Witteman
- Department of Family and Emergency Medicine, Faculty of Medicine, Laval University, Quebec City, Quebec, Canada
- VITAM Research Centre for Sustainable Health, Quebec City, Quebec, Canada
- Research Centre of the Quebec City Academic Medical Centre (CHU de Québec), Quebec City, Quebec, Canada
| | - Ananya Banerjee
- Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada
- Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada
| | - Justin Presseau
- Methodological and Implementation Research, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
- School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada
| | - Meranda Nakhla
- Department of Pediatrics, Division of Endocrinology, McGill University Health Centre, Montreal, Quebec, Canada
- Centre for Outcomes Research and Evaluation, Research Institute, McGill University Health Centre, Montreal, Quebec, Canada
| | - Maman Joyce Dogba
- Department of Family and Emergency Medicine, Faculty of Medicine, Laval University, Quebec City, Quebec, Canada
- Université Laval Research Center on Care and Front-Line Services - Pavillon Landry-Poulin, Quebec City, Quebec, Canada
| | - Leif Erik Lovblom
- IHPME, University of Toronto, Toronto, Ontario, Canada
- Biostatistics Department, University Health Network, Toronto, Ontario, Canada
| | - Rémi Rabasa-Lhoret
- Montreal Institute for Clinical Research (IRCM), Montreal, Quebec, Canada
- Department of Nutrition, Faculty of Medicine, Université de Montréal, Montreal, Quebec, Canada
- Endocrinology Division, Montreal University Center Hospital (CHUM), Montreal, Quebec, Canada
| | - Anne-Sophie Brazeau
- Faculty of Agricultural and Environmental Sciences, School of Human Nutrition, McGill University, Montreal, Quebec, Canada
| | - Adhiyat Najam
- Patient Partner - Person With Lived Type 1 Diabetes Experience, Toronto, Ontario, Canada
| | - Wajeeha Cheema
- Patient Partner - Person With Lived Type 1 Diabetes Experience, Toronto, Ontario, Canada
| | - Christine MacGibbon
- Patient Partner - Person With Lived Type 1 Diabetes Experience, Toronto, Ontario, Canada
| | - Alanna Weisman
- Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Ontario, Canada
- Department of Medicine, University of Toronto, Toronto, Ontario, Canada
- ICES, Toronto, Ontario, Canada
- IHPME, University of Toronto, Toronto, Ontario, Canada
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Ohaegbulam K, Anderson C, Thompson RF, Mitin T. Common Medical Comorbidities Influence Pneumonitis Risk After Chemoradiotherapy and Durvalumab Maintenance in Stage III Non-small Cell Lung Cancer. Clin Lung Cancer 2025:S1525-7304(25)00082-8. [PMID: 40374425 DOI: 10.1016/j.cllc.2025.04.012] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/23/2024] [Revised: 04/21/2025] [Accepted: 04/22/2025] [Indexed: 05/17/2025]
Abstract
OBJECTIVE Approximately 25% of patients with non-small cell lung cancer (NSCLC) present with Stage III disease. The standard treatment for inoperable patients involves definitive chemoradiotherapy (CRT) followed by 12 months of maintenance durvalumab. However, the incidence of pneumonitis-an adverse effect of this regimen-affects a significant proportion of patients. This study aimed to identify predictors of pneumonitis in a large cohort of patients with unresectable Stage III NSCLC receiving CRT and durvalumab, with a focus on common medical comorbidities. METHODS Using data from the Veterans Health Administration's Corporate Data Warehouse, we identified 1,524 patients who received the standard regimen between June 2017 and July 2023. Pneumonitis was assessed via ICD codes and severity determined using National Cancer Institute criteria. We analyzed associations between pneumonitis and various covariates including age, comorbidities, and medication use. RESULTS Our findings indicated a cumulative pneumonitis incidence of 14.5%, with 7.68% of cases classified as grade 3 or higher. Significant risk factors included advanced age, higher Charlson Comorbidity Index (CCI), prior pneumonia, diabetes, obesity, and antibiotic use, particularly cephalosporins and macrolides. Notably, severe chronic obstructive pulmonary disease (COPD) and uncontrolled diabetes were associated with an increased risk of pneumonitis. In contrast, prior tobacco use and better ECOG performance status (lower score) were protective. CONCLUSION These results highlight the complex interplay between comorbid conditions, medication, and pneumonitis risk in patients undergoing CRT and durvalumab therapy. Further research is needed to explore these relationships and potentially inform strategies to mitigate pneumonitis risk.
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Affiliation(s)
- Kim Ohaegbulam
- Department of Radiation Medicine, Oregon Health & Science University, Portland, OR
| | | | - Reid F Thompson
- Department of Radiation Medicine, Oregon Health & Science University, Portland, OR; Division of Hospital and Specialty Medicine, VA Portland Healthcare System, Portland, OR.
| | - Timur Mitin
- Department of Radiation Medicine, Oregon Health & Science University, Portland, OR.
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Zhang L, Gao X, Meng X, Ma G, Li J, Wang W, Chen S, Ma Y, Yu P, Zhou S. Rectify the impact of shorter red blood cell lifespan upon HbA1c detection values in T2DM patients: modeling and internal-external verification. Front Endocrinol (Lausanne) 2025; 16:1500660. [PMID: 40303638 PMCID: PMC12037378 DOI: 10.3389/fendo.2025.1500660] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/23/2024] [Accepted: 03/28/2025] [Indexed: 05/02/2025] Open
Abstract
Aims To determine the effect of red blood cell (RBC) lifespan variability on glycosylated hemoglobin (HbA1c) measurements in type 2 diabetes mellitus (T2DM) individuals and develop a mathematical model for adjusting HbA1c values. Methods We tracked glucose levels in 516 T2DM patients from Chu Hsien-I Memorial Hospital, categorized into Construction (n = 416) and Internal (n = 100) cohorts. Additionally, 165 participants from Tianjin diabetic retinopathy screening cohort, serving as the Independent cohort. RBC lifespan was determined using the CO breath test, and Hemoglobin glycation variation index (HGI) was calculated from the difference between measured and estimated HbA1c (eHbA1c). Model efficacy was evaluated using AUC, accuracy, sensitivity, and specificity. Results An inflection in the HGI-RBC lifespan model occurred at 66 days, with HbA1c underestimation when RBC lifespan was below 90 days, notably in the ≤ 66 days group. This underestimation increased the risk of cardiovascular and peripheral neuropathy complications. To rectify the impact of the shorter RBC lifespan in T2DM patients, the correction formula was established as HbA1c(c) = -0.05629×RBC lifespan + 1.127×HbA1c + 3.178 (R = 0.7360) in the ≤ 66 day lifespan group and HbA1c(c) = -0.004772 × RBC lifespan + 0.7569 × HbA1c + 2.394 (R = 0.7344) in the 67 to 89 day group. The corrected HbA1c models exhibited satisfactory predictive performance in all cohorts. Conclusions Accurate adjustment for the effects of RBC lifespan on HbA1c values in T2DM patients is expected to enhance blood glucose management and the efficacious prevention and treatment of diabetes-associated complications. Clinical Trial Registration Chu Hsien-I Memorial Hospital of Tianjin Medical University, identifier ChiCTR2100046557.
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Affiliation(s)
- Li Zhang
- NHC Key Laboratory of Hormones and Development, Chu Hsien-I Memorial Hospital and Tianjin Institute of Endocrinology, Tianjin Medical University, Tianjin, China
- Tianjin Key Laboratory of Metabolic Diseases, Tianjin Medical University, Tianjin, China
| | - Ximan Gao
- NHC Key Laboratory of Hormones and Development, Chu Hsien-I Memorial Hospital and Tianjin Institute of Endocrinology, Tianjin Medical University, Tianjin, China
- Tianjin Key Laboratory of Metabolic Diseases, Tianjin Medical University, Tianjin, China
| | - Xuying Meng
- NHC Key Laboratory of Hormones and Development, Chu Hsien-I Memorial Hospital and Tianjin Institute of Endocrinology, Tianjin Medical University, Tianjin, China
- Department of Endocrinology, The Second Hospital of Tianjin Medical University, Tianjin, China
| | - Guangyang Ma
- NHC Key Laboratory of Hormones and Development, Chu Hsien-I Memorial Hospital and Tianjin Institute of Endocrinology, Tianjin Medical University, Tianjin, China
- Tianjin Key Laboratory of Metabolic Diseases, Tianjin Medical University, Tianjin, China
| | - Jing Li
- NHC Key Laboratory of Hormones and Development, Chu Hsien-I Memorial Hospital and Tianjin Institute of Endocrinology, Tianjin Medical University, Tianjin, China
- Tianjin Key Laboratory of Metabolic Diseases, Tianjin Medical University, Tianjin, China
| | - Weilin Wang
- NHC Key Laboratory of Hormones and Development, Chu Hsien-I Memorial Hospital and Tianjin Institute of Endocrinology, Tianjin Medical University, Tianjin, China
- Tianjin Key Laboratory of Metabolic Diseases, Tianjin Medical University, Tianjin, China
| | - Sisi Chen
- NHC Key Laboratory of Hormones and Development, Chu Hsien-I Memorial Hospital and Tianjin Institute of Endocrinology, Tianjin Medical University, Tianjin, China
- Tianjin Key Laboratory of Metabolic Diseases, Tianjin Medical University, Tianjin, China
| | - Yongjian Ma
- Guangdong Breath Test Engineering and Technology Research Center, Shenzhen University, Shenzhen, China
| | - Pei Yu
- NHC Key Laboratory of Hormones and Development, Chu Hsien-I Memorial Hospital and Tianjin Institute of Endocrinology, Tianjin Medical University, Tianjin, China
- Tianjin Key Laboratory of Metabolic Diseases, Tianjin Medical University, Tianjin, China
| | - Saijun Zhou
- NHC Key Laboratory of Hormones and Development, Chu Hsien-I Memorial Hospital and Tianjin Institute of Endocrinology, Tianjin Medical University, Tianjin, China
- Tianjin Key Laboratory of Metabolic Diseases, Tianjin Medical University, Tianjin, China
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Khan H, Girdharry NR, Massin SZ, Abu-Raisi M, Saposnik G, Mamdani M, Qadura M. Current Prognostic Biomarkers for Peripheral Arterial Disease: A Comprehensive Systematic Review of the Literature. Metabolites 2025; 15:224. [PMID: 40278353 PMCID: PMC12029480 DOI: 10.3390/metabo15040224] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/22/2025] [Revised: 03/13/2025] [Accepted: 03/19/2025] [Indexed: 04/26/2025] Open
Abstract
Background: Peripheral arterial disease (PAD) is a chronic atherosclerotic disease characterized by atheromatous plaque buildup within arteries of the lower limbs. It can lead to claudication, skin ulcerations, and, in severe cases, chronic limb-threatening ischemia, requiring amputation. There are several plasma protein biomarkers that have been suggested as prognostic markers for adverse events, including major adverse cardiovascular and limb events. However, the clinical benefit and ability to clinically adapt these biomarkers remains uncertain due to inconsistent findings possibly related to heterogenous study designs and differences in methodology. Objectives: This review aims to evaluate the current literature on the prognostic value of plasma protein biomarkers for PAD, their predictive ability for PAD-related adverse outcomes, and their potential roles in guiding PAD management. Methods: To address these challenges, we conducted a systematic review of MEDLINE, Embase, and Cochrane CENTRAL libraries of the current literature (2010-2024). Results: We found 55 studies that evaluated the prognostic value of 44 distinct plasma proteins across various pathophysiological processes. These included markers of immunity and inflammation, markers of metabolism, cardiac biomarkers, markers of kidney function, growth factors and hormones, markers of coagulation and platelet function, extracellular matrix and tissue remodeling proteins, and transport proteins. This review summarizes the existing evidence for prognostic protein plasma biomarkers for PAD and their association with adverse events related to PAD. Conclusions: With this review, we hope to provide a comprehensive list of the prognostic markers and their value as prognostic biomarkers to guide clinical decision making in these patients.
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Affiliation(s)
- Hamzah Khan
- Division of Vascular Surgery, St. Michael’s Hospital, Toronto, ON M5B 1W8, Canada; (H.K.)
- Li Ka Shing Knowledge Institute, St. Michael’s Hospital—Unity Health Toronto, Toronto, ON M5B 1T8, Canada
| | | | - Sophia Z. Massin
- Toronto General Hospital, University Health Network, Toronto, ON M5G 2C4, Canada
| | - Mohamed Abu-Raisi
- Division of Vascular Surgery, St. Michael’s Hospital, Toronto, ON M5B 1W8, Canada; (H.K.)
| | - Gustavo Saposnik
- Li Ka Shing Knowledge Institute, St. Michael’s Hospital—Unity Health Toronto, Toronto, ON M5B 1T8, Canada
- Division of Neurology, Department of Medicine, University of Toronto, Toronto, ON M5S 3H2, Canada
| | - Muhammad Mamdani
- Division of Neurology, Department of Medicine, University of Toronto, Toronto, ON M5S 3H2, Canada
| | - Mohammad Qadura
- Division of Vascular Surgery, St. Michael’s Hospital, Toronto, ON M5B 1W8, Canada; (H.K.)
- Li Ka Shing Knowledge Institute, St. Michael’s Hospital—Unity Health Toronto, Toronto, ON M5B 1T8, Canada
- Vascular Surgery, Heart, Vascular & Thoracic Institute, Cleveland Clinic, Abu Dhabi PO Box 112412, United Arab Emirates
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Abu Khadija H, Alnees M, Gandelman G, Awwad M, Schiller T, Hamdan Y, Ayyad O, Kirzhner A, Sella G, Kashquosh Y, Kakoush N, Blatt A, George J. Clinical Impact of Glucose Levels on Patient Outcome after Transcatheter Aortic Valve Replacement. Rev Cardiovasc Med 2025; 26:25336. [PMID: 40026524 PMCID: PMC11868884 DOI: 10.31083/rcm25336] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/22/2024] [Revised: 11/30/2024] [Accepted: 12/06/2024] [Indexed: 03/05/2025] Open
Abstract
Background Limited data are available for evaluating the effect of blood glucose on transcatheter aortic valve replacement (TAVR) outcomes in patients with diabetes. We aimed to assess the impact of glucose levels on short-term and long-term adverse outcomes in patients undergoing TAVR. Methods and Results Data from severe aortic stenosis (AS) patients who underwent TAVR from 2010 to 2022 were collected retrospectively. In total, 615 patients were enrolled in the study: Among the total patient population, 43% had diabetes mellitus (DM), with a mean hemoglobin A1c (HbA1c) level of 7.4 ± 2.5. Within this cohort, 33% were classified as having uncontrolled diabetes, while 17% were considered well-controlled. Diabetic patients were younger (80.7 ± 6.8 vs. 82.0 ± 6.8 years, p = 0.001) and had more cardiovascular risk factors. No significant differences were found in outcomes between the two groups during the twelve-year follow-up. A multivariable logistic regression analysis was conducted on 270 DM patients to examine the impact of blood glucose levels and HbA1c on outcomes such as arrhythmia, stroke, and acute kidney injury (AKI). For arrhythmia, the odds ratio for HbA1c and blood glucose were 1.1039 (p = 0.23), and 0.998 (p = 0.76), indicating no significant associations. In stroke cases, HbA1c had an odds ratio of 1.194 (p = 0.36), while an odds ratio of 1.020 (p = 0.013) for blood glucose indicated a significant association. Notably, for AKI, the odds ratio for HbA1c was 2.304 (p = 0.02), indicating a significant link between higher HbA1c levels and increased AKI risk, with blood glucose levels trending toward significance (odds ratio = 1.0137, p = 0.061). Conclusions Diabetic status is a predictor of short-term outcomes following TAVR. Thus, these screening parameters should be included in risk assessment tools for TAVR candidates.
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Affiliation(s)
- Haitham Abu Khadija
- Department of Cardiology, Kaplan Medical Center and Faculty of Medicine, Hebrew University of Jerusalem, 9160401 Jerusalem, Israel
| | - Mohammad Alnees
- Department of Cardiology, Kaplan Medical Center and Faculty of Medicine, Hebrew University of Jerusalem, 9160401 Jerusalem, Israel
- Harvard Medical School, Postgraduate Medical Education, Global Clinical Scholer Research Training Program, Boston, MA 02115, USA
| | - Gera Gandelman
- Department of Cardiology, Kaplan Medical Center and Faculty of Medicine, Hebrew University of Jerusalem, 9160401 Jerusalem, Israel
| | - Mahdi Awwad
- Department of Cardiology, Kaplan Medical Center and Faculty of Medicine, Hebrew University of Jerusalem, 9160401 Jerusalem, Israel
| | - Tal Schiller
- Department of Diabetes, Endocrinology and Metabolism, Kaplan Medical Center and Faculty of Medicine, Hebrew University of Jerusalem, 9160401 Jerusalem, Israel
| | - Yazan Hamdan
- Department of Cardiology, Kaplan Medical Center and Faculty of Medicine, Hebrew University of Jerusalem, 9160401 Jerusalem, Israel
| | - Omar Ayyad
- Department of Cardiology, Kaplan Medical Center and Faculty of Medicine, Hebrew University of Jerusalem, 9160401 Jerusalem, Israel
| | - Alena Kirzhner
- Department of Internal Medicine A, Kaplan Medical Center and Faculty of Medicine, Hebrew University of Jerusalem, 9160401 Jerusalem, Israel
| | - Gal Sella
- Department of Cardiology, Kaplan Medical Center and Faculty of Medicine, Hebrew University of Jerusalem, 9160401 Jerusalem, Israel
| | - Yazid Kashquosh
- Department of Cardiology, Kaplan Medical Center and Faculty of Medicine, Hebrew University of Jerusalem, 9160401 Jerusalem, Israel
| | - Nadin Kakoush
- Department of Cardiology, Kaplan Medical Center and Faculty of Medicine, Hebrew University of Jerusalem, 9160401 Jerusalem, Israel
| | - Alex Blatt
- Department of Cardiology, Kaplan Medical Center and Faculty of Medicine, Hebrew University of Jerusalem, 9160401 Jerusalem, Israel
| | - Jacob George
- Department of Cardiology, Kaplan Medical Center and Faculty of Medicine, Hebrew University of Jerusalem, 9160401 Jerusalem, Israel
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Helbert S, Hardy AF. Analyse phénoménologique de l’expérience vécue du patient ayant un diabète de type 2 et hospitalisé pour déséquilibre glycémique chronique. Rech Soins Infirm 2025; 159:12-23. [PMID: 40387818 DOI: 10.3917/rsi.159.0012] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 05/20/2025]
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Al-Naseri RF, Alibrahim NT, Al-Salait SK, Mansour AA. The Performance of Three Systems of Glycated Hemoglobin Measurements Among Patients With Sickle Cell Trait in Basrah, Iraq. Cureus 2025; 17:e77374. [PMID: 39958094 PMCID: PMC11826104 DOI: 10.7759/cureus.77374] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 01/13/2025] [Indexed: 02/18/2025] Open
Abstract
Background Hemoglobin variants may cause mismanagement of diabetes resulting from false glycated hemoglobin (HbA1c) results. The aim of this study was to compare the results obtained from three different HbA1c assay systems among patients with sickle cell trait (SCT) at Faiha Specialized Diabetes, Endocrine, and Metabolism Center (FDEMC) in Basrah. Methods A cross-sectional observational study was done in FDEMC in Basrah on patients with established diagnoses of diabetes mellitus. All samples were analyzed at FDEMC laboratory by using three different systems: Roche Cobas Integra Gen.2 (COBAS INTEGRA® 400 plus analyzer immunoassay) (Roche Diagnostics, Indianapolis, IN), a turbidimetric inhibition immunoassay (TINIA), Bio-Rad Variant II Turbo (Bio-Rad, Hercules, CA) Ion exchange HPLC method, and Bio-Rad D-10 (A1c program) (Bio-Rad, Hercules, CA) Ion exchange HPLC method. Results We enrolled 139 persons with diabetes and SCT compared with 70 controls with diabetes and no SCT. A significant difference in the mean HbA1c levels between Roche Cobas Integra Gen.2 and Bio-Rad Variant II Turbo in comparison with Bio-Rad D-10 (A1c program) across all strata of HbA1c in SCT. The highest difference was -0.5% in the stratum of HbA1c 7 to 9% group in Roche Cobas Integra Gen.2, while it was +0.8% in the stratum of HbA1c less than 7% in the SCT group. For the control group, the highest difference was -1.3%, seen in the stratum of HbA1c, more than 9% in the Roche Cobas Integra Gen.2, while the highest difference in the Bio-Rad Variant II Turbo was +0.5% in the same stratum. In both groups, the results of HbA1c were mostly higher in the Bio-Rad Variant II Turbo and lower in Roche Cobas Integra Gen.2. Conclusion Roche Cobas Integra Gen.2 and Bio-Rad Variant II Turbo methods are not preferred to be used in HbA1c estimation in areas where SCT is prevalent. Diagnosing or follow-up of glycemic control in patients with SCT needs critical reappraisal because of the limitation of methods used to measure HbA1c in Basrah.
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Affiliation(s)
- Rafid F Al-Naseri
- Endocrinology and Diabetes, Faiha Specialized Diabetes, Endocrine and Metabolism Center, Basrah, IRQ
| | - Nassar T Alibrahim
- Endocrinology and Diabetes, Faiha Specialized Diabetes, Endocrine and Metabolism Center, Basrah, IRQ
| | - Sadeq K Al-Salait
- Pathology and Laboratory Medicine, Al-Zahraa College of Medicine, Basrah, IRQ
| | - Abbas A Mansour
- Endocrinology and Diabetes, Faiha Specialized Diabetes, Endocrine and Metabolism Center, Basrah, IRQ
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10
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Watanabe Y, Yamaguchi T, Sasaki A, Naitoh T, Matsubara H, Yokote K, Okazumi S, Ugi S, Yamamoto H, Ohta M, Ishigaki Y, Kasama K, Seki Y, Tsujino M, Shirai K, Miyazaki Y, Masaki T, Nagayama D, Tatsuno I, Saiki A. Effects of laparoscopic sleeve gastrectomy on weight loss and metabolic improvement in subjects aged 65 years or older: a subanalysis of J-SMART study. Diabetol Int 2025; 16:56-64. [PMID: 39877443 PMCID: PMC11769886 DOI: 10.1007/s13340-024-00767-w] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/04/2024] [Accepted: 10/03/2024] [Indexed: 01/31/2025]
Abstract
Aim To investigate the effect of weight loss and metabolic improvement after laparoscopic sleeve gastrectomy (LSG) in older adults aged 65 years or over compared with younger adults in a retrospective analysis. Methods The J-SMART study database of 322 Japanese individuals with body mass index (BMI) ≥32 kg/m2 who underwent LSG between 2011 and 2014 at 10 centers accredited by the Japanese Society for Treatment of Obesity were analyzed. The subjects were classified into two groups: ≥65 age group (range, 65-76 years; n = 25) and <65 age group (range, 22-64 years; n = 297). Clinical parameters were compared between the groups. Results Baseline data for the ≥65 vs. <65 age groups were: median age 67 years vs. 45 years; weight 92.7 kg vs. 114.4 kg; BMI 40.0 kg/m2 vs. 41.9 kg/m2; and HbA1c 6.8% vs. 6.5%. The ≥65 age group had significantly lower preoperative weight, BMI, estimated glomerular filtration rate, and ABCD score, but higher visceral fat area and prevalence of diabetes, hypertension, and obstructive sleep apnea (OSAS). Weight was significantly reduced in both groups throughout 5 years post-LSG, though total weight loss at 2 years was lower in the ≥65 age group (28.0%) than in the <65 group (30.0%). Remission rates of diabetes, hypertension, OSAS, and joint disorders 2 years after LSG showed no significant differences, except for dyslipidemia. Conclusion LSG may be an efficacious option for improving obesity-related health problems in older adults. However, postoperative safety and complications were not evaluated in this study and further research is needed. Supplementary Information The online version contains supplementary material available at 10.1007/s13340-024-00767-w.
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Affiliation(s)
- Yasuhiro Watanabe
- Center of Diabetes, Endocrinology and Metabolism, Toho University Sakura Medical Center, Sakura, Chiba Japan
| | - Takashi Yamaguchi
- Center of Diabetes, Endocrinology and Metabolism, Toho University Sakura Medical Center, Sakura, Chiba Japan
- Yamaguchi Internal Medicine and Diabetes Clinic, Yotsukaido, Chiba Japan
| | - Akira Sasaki
- Department of Surgery, Iwate Medical University School of Medicine, Yahaba, Iwate Japan
| | - Takeshi Naitoh
- Department of Lower Gastrointestinal Surgery, Kitasato University School of Medicine, Sagamihara, Kanagawa Japan
| | - Hisahiro Matsubara
- Department of Frontier Surgery, Graduate School of Medicine, Chiba University, Chiba, Chiba Japan
| | - Koutaro Yokote
- Department of Endocrinology, Hematology and Gerontology, Chiba University Graduate School of Medicine, Chiba, Chiba Japan
| | - Shinichi Okazumi
- Japan Community Health Care Organization Chiba Hospital, Chiba, Chiba Japan
- Department of Surgery, Toho University Sakura Medical Center, Sakura, Chiba Japan
| | - Satoshi Ugi
- Department of Medicine, Shiga University of Medical Science, Otsu, Shiga Japan
- Department of Medicine, Omihachiman Community Medical Center, Omihachiman, Shiga Japan
| | - Hiroshi Yamamoto
- Department of Weight Loss and Metabolic Surgery, Japan Community Health Care Organization Shiga Hospital, Otsu, Shiga Japan
| | - Masayuki Ohta
- Research Center for GLOBAL and LOCAL Infectious Diseases, Oita University, Yufu, Oita Japan
- Department of Gastroenterological and Pediatric Surgery, Faculty of Medicine, Oita University, Yufu, Oita Japan
| | - Yasushi Ishigaki
- Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, Iwate Medical University, Yahaba, Iwate Japan
| | - Kazunori Kasama
- Weight Loss and Metabolic Surgery Center, Yotsuya Medical Cube, Chiyoda, Tokyo Japan
| | - Yosuke Seki
- Weight Loss and Metabolic Surgery Center, Yotsuya Medical Cube, Chiyoda, Tokyo Japan
| | - Motoyoshi Tsujino
- Department of Endocrinology and Metabolism, Tokyo Metropolitan Tama Medical Center, Fuchu, Tokyo Japan
| | - Kohji Shirai
- Department of Internal Medicine, Mihama Hospital, Chiba, Chiba Japan
| | - Yasuhiro Miyazaki
- Department of Surgery, Osaka General Medical Center, Osaka, Osaka Japan
| | - Takayuki Masaki
- Department of Endocrinology, Metabolism, Rheumatology and Nephrology, Faculty of Medicine, Oita University, Yufu, Oita Japan
| | - Daiji Nagayama
- Center of Diabetes, Endocrinology and Metabolism, Toho University Sakura Medical Center, Sakura, Chiba Japan
- Nagayama Clinic, Oyama, Tochigi Japan
| | - Ichiro Tatsuno
- Center of Diabetes, Endocrinology and Metabolism, Toho University Sakura Medical Center, Sakura, Chiba Japan
- Chiba Prefecture University of Health Sciences, Chiba, Chiba Japan
| | - Atsuhito Saiki
- Center of Diabetes, Endocrinology and Metabolism, Toho University Sakura Medical Center, Sakura, Chiba Japan
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11
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Shetty P, Dsouza R, Kumar B V. Matrix Metalloproteinase-9 as a Predictor of Healing in Diabetic Foot Ulcers. Cureus 2024; 16:e75521. [PMID: 39803151 PMCID: PMC11723777 DOI: 10.7759/cureus.75521] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 12/10/2024] [Indexed: 01/16/2025] Open
Abstract
Background Wound healing in diabetic foot ulcers (DFUs) is hindered by several physiological and biochemical abnormalities, including prolonged inflammation, an imbalance in extracellular matrix (ECM) synthesis and degradation, insufficient neovascularization, and reduced macrophage activity. In DFUs, excessive and uncontrolled matrix metalloproteinases (MMPs) degrade the ECM and impede wound healing. Matrix metalloproteinase-9 (MMP-9) concentration plays a key role in inflammation and ECM degradation. This study explores the relationship between wound type in DFUs and MMP-9 levels, hypothesizing that a high MMP-9 environment may indicate inflammation and impaired wound healing. Materials and methods Forty individuals with type 2 diabetes and foot ulcers were recruited for the study. The participants were divided into two groups: nonhealing and healing, with 20 patients in each group. Biopsy samples were homogenized, and MMP-9 activity was measured using an ELISA. Results The MMP-9 concentration was significantly higher in nonhealing ulcers compared to healing ulcers. Receiver operating characteristic analysis revealed that MMP-9 measurement was the most accurate predictor of wound healing, with an area under the curve value of 0.945 and high sensitivity and specificity. Although there was a weak correlation between MMP-9 concentration and glycosylated hemoglobin, it was not statistically significant. Conclusions MMP-9 expression serves as a marker of poor wound healing. MMP-9 levels in the wound at the time of presentation may predict the healing trajectory and help tailor a specific treatment plan for each DFU patient.
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Affiliation(s)
- Prathvi Shetty
- General Surgery, Father Muller Medical College, Mangalore, IND
| | - Rohan Dsouza
- General Surgery, Father Muller Medical College, Mangalore, IND
| | - Vinoda Kumar B
- General Surgery, Father Muller Medical College, Mangalore, IND
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12
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Setford S, Phillips S, Cameron H, Grady M. Clinical Accuracy of a Glucose Oxidase-Based Blood Glucose Test-Strip Across Extremes of Oxygen Partial Pressure. J Diabetes Sci Technol 2024; 18:1445-1451. [PMID: 36879470 PMCID: PMC11531037 DOI: 10.1177/19322968231158663] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 03/08/2023]
Abstract
BACKGROUND Glucose oxidase (GOx)-based blood glucose monitors (BGMs) are influenced by the partial pressure of oxygen (Po2) within the applied sample. Limited in-clinic data exists regarding the quantitative effect of Po2 in unmanipulated capillary fingertip blood samples across physiologically representative glucose and Po2 ranges. METHOD Clinical accuracy data were collected as part of a BGM manufacturer's ongoing post-market surveillance program for a commercially available GOx-based BGM test-strip. The data set comprised 29 901 paired BGM-comparator readings and corresponding Po2 values from 5 428 blood samples from a panel of 975 subjects. RESULTS A linear regression-calculated bias range of 5.22% (+0.72% [low Po2: 45 mm Hg] to -4.5% [high Po2: 105 mm Hg]); biases calculated as absolute at <100 mg/dL glucose was found. Below the nominal Po2 of 75 mm Hg, a linear regression bias of +3.14% was calculated at low Po2, while negligible impact on bias (regression slope: +0.002%) was observed at higher than nominal levels (>75 mm Hg). When evaluating BGM performance under corner conditions of low (<70 mg/dL) and high (>180 mg/dL) glucose, combined with low and high Po2, linear regression biases ranged from +1.52% to -5.32% within this small group of subjects and with no readings recorded at <70 mg/dL glucose at low and high Po2. CONCLUSIONS Data from this large-scale clinical study, performed on unmanipulated fingertip capillary bloods from a diverse diabetes population, indicate Po2 sensitivity of the BGM to be markedly lower than published studies, which are mainly laboratory-based, requiring artificial manipulation of oxygen levels in aliquots of venous blood.
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13
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Zhou Y, Liu S, Zhang Q, Zhang S, Wu S, Zhu S. Bidirectional association between type 2 diabetes and irritable bowel syndrome: A large-scale prospective cohort study. Diabetes Obes Metab 2024; 26:5107-5115. [PMID: 39165053 DOI: 10.1111/dom.15852] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/13/2024] [Revised: 07/09/2024] [Accepted: 07/11/2024] [Indexed: 08/22/2024]
Abstract
AIM To examine the bidirectional association between type 2 diabetes (T2D) and irritable bowel syndrome (IBS) in a large prospective population cohort. METHODS Participants free of IBS at baseline in the UK Biobank were included in the analysis of T2D and incident IBS (cohort 1), with 11 140 T2D patients and 413 979 non-T2D patients. Similarly, those free of T2D at baseline were included in the analysis of IBS and incident T2D (cohort 2), with 21 944 IBS patients and 413 979 non-IBS patients. Diagnoses of T2D and IBS were based on International Classification of Disease-10 codes. The Cox proportional hazards model was used to estimate adjusted hazard ratios (HRs). RESULTS In cohort 1, 8984 IBS cases were identified during a median 14.5-year follow-up. Compared with non-T2D, T2D patients had a 39.0% increased risk of incident IBS (HR = 1.39, 95% confidence interval [CI]: 1.23-1.56, P < .001), with a higher IBS risk in those with higher fasting blood glucose levels (HR = 1.43, 95% CI: 1.19-1.72, P < .001) or longer T2D duration (HR = 1.47, 95% CI: 1.23-1.74, P < .001). In cohort 2, 29 563 incident T2D cases were identified. IBS patients had an 18.0% higher risk of developing T2D versus non-IBS patients (HR = 1.18, 95% CI: 1.12-1.24, P < .001). A similar excess T2D risk was observed in IBS patients with a duration of either less than 10 years, or of 10 years or longer. Further sensitivity analysis and subgroup analysis indicated consistent findings. CONCLUSIONS T2D and IBS exhibit a bidirectional association, with an increased risk of co-morbidity. Awareness of this association may improve the prevention and management of both diseases.
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Affiliation(s)
- Yesheng Zhou
- Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, State Key Laboratory for Digestive Health, National Clinical Research Center for Digestive Diseases, Beijing, China
| | - Si Liu
- Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, State Key Laboratory for Digestive Health, National Clinical Research Center for Digestive Diseases, Beijing, China
| | - Qian Zhang
- Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, State Key Laboratory for Digestive Health, National Clinical Research Center for Digestive Diseases, Beijing, China
| | - Shutian Zhang
- Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, State Key Laboratory for Digestive Health, National Clinical Research Center for Digestive Diseases, Beijing, China
| | - Shanshan Wu
- Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, State Key Laboratory for Digestive Health, National Clinical Research Center for Digestive Diseases, Beijing, China
| | - Shengtao Zhu
- Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, State Key Laboratory for Digestive Health, National Clinical Research Center for Digestive Diseases, Beijing, China
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14
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Flores-Hernández MN, Martínez-Coria H, López-Valdés HE, Arteaga-Silva M, Arrieta-Cruz I, Gutiérrez-Juárez R. Efficacy of a High-Protein Diet to Lower Glycemic Levels in Type 2 Diabetes Mellitus: A Systematic Review. Int J Mol Sci 2024; 25:10959. [PMID: 39456742 PMCID: PMC11507302 DOI: 10.3390/ijms252010959] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/20/2024] [Revised: 09/25/2024] [Accepted: 10/02/2024] [Indexed: 10/28/2024] Open
Abstract
Diabetes is a metabolic disease with a high worldwide prevalence and an important factor in mortality and disability in the population. Complications can be reduced or prevented with lifestyle changes in physical activity, dietary habits, and smoking cessation. High-protein diets (HPDs, >30% or >1.0 g/Kg/day) decrease hyperglycemia in part due to their content of branched-chain amino acids (BCAAs), mainly leucine. Leucine (and other BCAAs) improve glucose metabolism by directly signaling in the medio-basal hypothalamus (MBH), increasing liver insulin sensitivity. To determine the effectiveness of an HPD to lower hyperglycemia, we analyzed the results of published clinical studies focusing on the levels of fasting plasma glucose and/or glycosylated hemoglobin (HbA1c) in patients with type 2 diabetes mellitus (T2DM). We carried out a systematic search for clinical studies using HPDs. We searched five databases (Scopus, Web of Science, PubMed, Epistemonikos, and Cochrane), collecting 179 articles and finally selecting 8 articles to analyze their results. In conclusion, HPDs are an effective alternative to reduce hyperglycemia in patients with T2DM, especially so-called Paleolithic diets, due to their higher-quality protein from animal and vegetal sources and their exclusion of grains, dairy products, salt, refined fats, and added sugars.
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Affiliation(s)
- María Nelly Flores-Hernández
- Departamento de Ciencias Biomédicas, Escuela de Medicina, Facultad de Estudios Superiores Zaragoza, Universidad Nacional Autónoma de México, Mexico City 09230, Mexico;
| | - Hilda Martínez-Coria
- Departamento de Fisiología, Facultad de Medicina, Universidad Nacional Autónoma de México, Mexico City 04360, Mexico; (H.M.-C.); (H.E.L.-V.)
| | - Héctor E. López-Valdés
- Departamento de Fisiología, Facultad de Medicina, Universidad Nacional Autónoma de México, Mexico City 04360, Mexico; (H.M.-C.); (H.E.L.-V.)
| | - Marcela Arteaga-Silva
- Departamento de Biología de la Reproducción, Universidad Autónoma Metropolitana-Iztapalapa, Mexico City 09340, Mexico;
| | - Isabel Arrieta-Cruz
- Departamento de Investigación Básica, División de Investigación, Instituto Nacional de Geriatría, Secretaría de Salud, Mexico City 10200, Mexico;
| | - Roger Gutiérrez-Juárez
- Departamento de Ciencias Biomédicas, Escuela de Medicina, Facultad de Estudios Superiores Zaragoza, Universidad Nacional Autónoma de México, Mexico City 09230, Mexico;
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15
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Umegaki H. Management of older adults with diabetes mellitus: Perspective from geriatric medicine. J Diabetes Investig 2024; 15:1347-1354. [PMID: 39115890 PMCID: PMC11442781 DOI: 10.1111/jdi.14283] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/30/2024] [Accepted: 07/22/2024] [Indexed: 10/02/2024] Open
Abstract
Advances in diabetes medication and population aging are lengthening the lifespans of people with diabetes mellitus (DM). Older patients with diabetes mellitus often have multimorbidity and tend to have polypharmacy. In addition, diabetes mellitus is associated with frailty, functional decline, cognitive impairment, and geriatric syndrome. Although the numbers of patients with frailty, dementia, disability, and/or multimorbidity are increasing worldwide, the accumulated evidence on the safe and effective treatment of these populations remains insufficient. Older patients, especially those older than 75 years old, are often underrepresented in randomized controlled trials of various treatment effects, resulting in limited clinical evidence for this population. Therefore, a deeper understanding of the characteristics of older patients is essential to tailor management strategies to their needs. The clinical guidelines of several academic societies have begun to recognize the importance of relaxing glycemic control targets to prevent severe hypoglycemia and to maintain quality of life. However, glycemic control levels are thus far based on expert consensus rather than on robust clinical evidence. There is an urgent need for the personalized management of older adults with diabetes mellitus that considers their multimorbidity and function and strives to maintain a high quality of life through safe and effective medical treatment. Older adults with diabetes mellitus accompanied by frailty, functional decline, cognitive impairment, and multimorbidity require special management considerations and liaison with both carers and social resources.
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Affiliation(s)
- Hiroyuki Umegaki
- Department of Community Healthcare and GeriatricsNagoya University Graduate School of MedicineAichiJapan
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16
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Buckeridge C, Tsamandouras N, Carvajal-Gonzalez S, Brown LS, Hernandez-Illas M, Saxena AR. Once-daily oral small-molecule glucagon-like peptide-1 receptor agonist lotiglipron (PF-07081532) for type 2 diabetes and obesity: Two randomized, placebo-controlled, multiple-ascending-dose Phase 1 studies. Diabetes Obes Metab 2024; 26:3155-3166. [PMID: 38751362 DOI: 10.1111/dom.15643] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/10/2023] [Revised: 04/09/2024] [Accepted: 04/17/2024] [Indexed: 07/10/2024]
Abstract
AIM To investigate the effects of lotiglipron (PF-07081532), a once-daily, oral small-molecule glucagon-like peptide-1 receptor agonist, in participants with type 2 diabetes (T2D) and/or obesity. MATERIALS AND METHODS Two Phase 1 randomized, double-blind, placebo-controlled, multiple-ascending-dose studies were conducted to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of lotiglipron. RESULTS Across the studies, 74 participants with T2D were treated for 28 or 42 days, and 26 participants with obesity without diabetes were treated for 42 days, following randomization to placebo or lotiglipron (target doses 10-180 mg/day, with dose titration to higher target doses). Most adverse events were mild (89.6%), with nausea the most frequently reported in both studies. There were no clinically meaningful adverse trends noted in safety laboratory tests, vital signs, or electrocardiogram parameters. In participants with T2D, lotiglipron resulted in dose-dependent reductions in mean daily glucose. The 180-mg dose was associated with least squares mean decreases from baseline in glycated haemoglobin (-1.61% [90% confidence interval {CI} -2.08, -1.14] vs. -0.61% [-1.56, 0.34] for placebo) and body weight (-5.10 kg [90% CI -6.62, -3.58] vs. -2.06 kg [90% CI -4.47, 0.36] for placebo) after 42 days; a similar magnitude of weight loss was seen in participants with obesity. The observed pharmacokinetic profile supported once-daily dosing. CONCLUSIONS The profile of once-daily lotiglipron with doses up to 180 mg, as observed in these two Phase 1 studies, indicated a safety and tolerability profile consistent with the mechanism of action, with dose-dependent reductions in glycaemic indices (T2D) and body weight (both populations) after multiple doses. CLINICALTRIALS gov identifier: NCT04305587, NCT05158244.
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Affiliation(s)
- Clare Buckeridge
- Pfizer Worldwide Research and Development, Cambridge, Massachusetts, USA
| | | | | | - Lisa S Brown
- Pfizer Worldwide Research and Development, Collegeville, Pennsylvania, USA
| | | | - Aditi R Saxena
- Pfizer Worldwide Research and Development, Cambridge, Massachusetts, USA
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17
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Jafari A, Moshki M, Naddafi F, Ghelichi-Ghojogh M, Armanmehr V, Kazemi K, Nejatian M. Depression literacy, mental health literacy, and their relationship with psychological status and quality of life in patients with type 2 diabetes mellitus. Front Public Health 2024; 12:1421053. [PMID: 39056082 PMCID: PMC11269263 DOI: 10.3389/fpubh.2024.1421053] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/21/2024] [Accepted: 06/24/2024] [Indexed: 07/28/2024] Open
Abstract
Background This study was conducted to measure depression literacy (D-Lit) and mental health literacy (MHL) and to investigate their relationship with psychological status and quality of life among Iranian patients with type 2 diabetes mellitus (T2DM). Methods This cross-sectional study was conducted in 2021 among 400 patients with T2DM in Iran. Samples were selected using proportional stratified sampling. Data collection tools comprised a demographic questionnaire, measures of MHL and D-Lit, the diabetes quality of life (DQOL) scale, and the DASS-21. After confirming the normality of the data using the Kolmogorov-Smirnov test, parametric statistical tests (such as one-way ANOVA, independent samples t-test, and Chi-Square) were used to investigate the relationship between the variables using SPSS v22 software. The results of continuous quantitative data are reported in the form of means and standard deviations, and qualitative data are reported in the form of absolute and relative frequencies. Results In this study, 10.25% of the participants (n = 41) had severe depression, while 36.75% (n = 147) experienced severe anxiety. The mean (standard deviation) of MHL was 80.92 (9.16) from 130 points. Of the participants, only 1.7% (n = 7) did not answer any questions correctly on the D-lit scale, and only 5.8% (n = 23) were able to answer 15 questions or more correctly on the D-lit. MHL had a significant negative correlation with depression (r = -0.236), anxiety (r = -0.243), and stress (r = -0.155) (P < 0.001). There was a positive and significant correlation between MHL and D-Lit (r = 0.186) (P < 0.001). D-Lit had a significant negative correlation with depression (r = -0.192), anxiety (r = -0.238), and stress (r = -0.156) (P < 0.001). There was a positive and significant correlation between the ability to recognize disorders (r = 0.163), knowledge of self-treatment (r = 0.154), and DQOL (P < 0.001). Depression (r = -0.251), anxiety (r = -0.257), and stress (r = -0.203) had a significant negative correlation with DQOL (P < 0.001). Conclusion MHL and D-Lit levels were found to be inadequate in patients with T2DM. These low levels of MHL and D-Lit among patients with T2DM were associated with higher levels of anxiety, depression, and stress, as well as a lower quality of life. Therefore, designing and implementing preventive programs to improve the mental health of patients with T2DM can help prevent mental disorders and ultimately improve their quality of life.
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Affiliation(s)
- Alireza Jafari
- Department of Health Education and Health Promotion, School of Health, Social Development and Health Promotion Research Center, Gonabad University of Medical Sciences, Gonabad, Iran
| | - Mahdi Moshki
- Department of Health Education and Health Promotion, School of Health, Social Development and Health Promotion Research Center, Gonabad University of Medical Sciences, Gonabad, Iran
| | - Fatemehzahra Naddafi
- Student Research Committee, Gonabad University of Medical Sciences, Gonabad, Iran
| | - Mousa Ghelichi-Ghojogh
- Neonatal and Children's Research Center, Department of Biostatistics and Epidemiology, School of Health, Golestan University of Medical Sciences, Gorgan, Iran
| | - Vajihe Armanmehr
- Social Development and Health Promotion Research Center, Gonabad University of Medical Sciences, Gonabad, Iran
| | - Kimia Kazemi
- Department of Clinical Psychology, Islamic Azad University, Birjand, Iran
| | - Mahbobeh Nejatian
- Social Determinants of Health Research Center, Gonabad University of Medical Sciences, Gonabad, Iran
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18
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Mela DJ, Alssema M, Hiemstra H, Hoogenraad AR, Kadam T. Effect of Low-Dose Mulberry Fruit Extract on Postprandial Glucose and Insulin Responses: A Randomized Pilot Trial in Individuals with Type 2 Diabetes. Nutrients 2024; 16:2177. [PMID: 39064619 PMCID: PMC11280168 DOI: 10.3390/nu16142177] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/08/2024] [Revised: 06/27/2024] [Accepted: 07/08/2024] [Indexed: 07/28/2024] Open
Abstract
Adding mulberry fruit extract (MFE) to carbohydrate-rich meals can reduce postprandial glucose (PPG) and insulin (PPI) responses in healthy individuals. This pilot study assessed the acute postprandial effects of low doses of MFE in individuals with type 2 diabetes. In a randomized cross-over (within-subjects) design, 24 unmedicated adult males and females with type 2 diabetes (mean [SD] age 51.0 [9.3] yr, BMI 27.5 [3.9] kg/m2) consumed meals with 0 (control), 0.37, and 0.75 g of MFE added to ~50 g of available carbohydrates from rice. Primary and secondary outcomes were the PPG 2 hr positive incremental area under the curve and the corresponding PPI. Results were reported as mean differences from the control meal with 95% CI. Relative to control, 0.37 and 0.75 g of MFE reduced the mean 2 hr PPG by 8.2% (-20.8 to 6.6%) and 22.4% (-38.6 to -1.9%), respectively, and reduced PPI by 9.6% (-20.7 to 3.0%) and 17.5% (-27.9 to -5.7%). There were no indications of adverse events or gastrointestinal discomfort. MFE additions also led to dose-related reductions in glucose peak and glucose swing. At these levels, MFE appears to dose-dependently reduce acute PPG and PPI in individuals with type 2 diabetes and may be a feasible dietary approach to help attenuate glycemic exposures.
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Affiliation(s)
- David J. Mela
- Unilever Foods Innovation Centre Wageningen, 6708 WH Wageningen, The Netherlands
| | - Marjan Alssema
- Unilever Foods Innovation Centre Wageningen, 6708 WH Wageningen, The Netherlands
| | - Harry Hiemstra
- Unilever Foods Innovation Centre Wageningen, 6708 WH Wageningen, The Netherlands
| | - Anne-Roos Hoogenraad
- Unilever Foods Innovation Centre Wageningen, 6708 WH Wageningen, The Netherlands
| | - Tanvi Kadam
- Unilever Industries Private Limited, Mumbai 400099, India
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19
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Herb T, Taylor AS, Li SH, Manthei DM, Gherasim C. Uncommon causes of hemoglobin E flags identified during measurement of hemoglobin A1c by ion-exchange high-performance liquid chromatography. Lab Med 2024; 55:528-533. [PMID: 38253465 DOI: 10.1093/labmed/lmad113] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/24/2024] Open
Abstract
We present 3 cases of discordant results from screening hemoglobin A1c (HbA1c) measured by ion-exchange high-performance liquid chromatography (HPLC) all due to various forms of interference and flagged by the instrument as "suspected hemoglobin E (HbE)." The first case was due to a rare hemoglobin variant, later confirmed to be hemoglobin Hoshida, the second due to "true" heterozygous HbE, and the third a result of analytical artifact causing splitting of the HbA1c peak without an underlying variant hemoglobin. We examine the similarities in these cases along with the laboratory work-up to classify each cause of interference to demonstrate the wide array of potential causes for the suspected HbE flag and why it warrants proper work-up. Because there is no standardized method of reporting out hemoglobin variant interference in HbA1c measurement, we discuss our laboratory's process of investigating discordant HbA1c measurements and reporting results in cases with variant interference as 1 possible model to follow, along with discussing the associated laboratory, ethical, and clinical considerations. We also examine the structure of hemoglobin Hoshida, HbE, and conduct a brief literature review of previous reports.
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Affiliation(s)
- Thomas Herb
- Department of Pathology, University of Michigan, Ann Arbor, MI, US
| | | | - Shih-Hon Li
- Department of Pathology, University of Michigan, Ann Arbor, MI, US
| | - David M Manthei
- Department of Pathology, University of Michigan, Ann Arbor, MI, US
| | - Carmen Gherasim
- Department of Pathology, University of Michigan, Ann Arbor, MI, US
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20
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Fuchs S, Caserto JS, Liu Q, Wang K, Shariati K, Hartquist CM, Zhao X, Ma M. A Glucose-Responsive Cannula for Automated and Electronics-Free Insulin Delivery. ADVANCED MATERIALS (DEERFIELD BEACH, FLA.) 2024; 36:e2403594. [PMID: 38639424 PMCID: PMC11223976 DOI: 10.1002/adma.202403594] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 03/10/2024] [Revised: 04/12/2024] [Indexed: 04/20/2024]
Abstract
Automated delivery of insulin based on continuous glucose monitoring is revolutionizing the way insulin-dependent diabetes is treated. However, challenges remain for the widespread adoption of these systems, including the requirement of a separate glucose sensor, sophisticated electronics and algorithms, and the need for significant user input to operate these costly therapies. Herein, a user-centric glucose-responsive cannula is reported for electronics-free insulin delivery. The cannula-made from a tough, elastomer-hydrogel hybrid membrane formed through a one-pot solvent exchange method-changes permeability to release insulin rapidly upon physiologically relevant varying glucose levels, providing simple and automated insulin delivery with no additional hardware or software. Two prototypes of the cannula are evaluated in insulin-deficient diabetic mice. The first cannula-an ends-sealed, subcutaneously inserted prototype-normalizes blood glucose levels for 3 d and controls postprandial glucose levels. The second, more translational version-a cannula with the distal end sealed and the proximal end connected to a transcutaneous injection port-likewise demonstrates tight, 3-d regulation of blood glucose levels when refilled twice daily. This proof-of-concept study may aid in the development of "smart" cannulas and next-generation insulin therapies at a reduced burden-of-care toll and cost to end-users.
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Affiliation(s)
- Stephanie Fuchs
- Biological and Environmental Engineering, Cornell University, Ithaca, NY, 14853, USA
| | - Julia S. Caserto
- Robert Frederick Smith School of Chemical and Biomolecular Engineering, Cornell University, Ithaca NY, 14853, USA
| | - Qingsheng Liu
- Biological and Environmental Engineering, Cornell University, Ithaca, NY, 14853, USA
| | - Kecheng Wang
- Biological and Environmental Engineering, Cornell University, Ithaca, NY, 14853, USA
| | - Kaavian Shariati
- Biological and Environmental Engineering, Cornell University, Ithaca, NY, 14853, USA
| | - Chase M. Hartquist
- Department of Mechanical Engineering, Massachusetts Institute of Technology, Cambridge, MA, USA
| | - Xuanhe Zhao
- Department of Mechanical Engineering, Massachusetts Institute of Technology, Cambridge, MA, USA
| | - Minglin Ma
- Biological and Environmental Engineering, Cornell University, Ithaca, NY, 14853, USA
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21
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Zhang Z, Lv D, You Y, Zhao Z, Hu W, Xie F, Lin Y, Xie W, Wu X. Assessing the importance of risk factors for diabetic retinopathy in patients with type 2 diabetes mellitus: Results from the classification and regression tree models. J Family Community Med 2024; 31:197-205. [PMID: 39176009 PMCID: PMC11338385 DOI: 10.4103/jfcm.jfcm_354_23] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/19/2023] [Revised: 04/11/2024] [Accepted: 05/30/2024] [Indexed: 08/24/2024] Open
Abstract
BACKGROUND Diabetic retinopathy (DR) is one of the serious complications of diabetes mellitus (DM). Many studies have identified the risk factors associated with DR, but there is not much evidence on the importance of these factors for DR. This study aimed to investigate the associated factors for patients with type 2 DM (T2DM) and calculate the importance of the identified factors. MATERIALS AND METHODS Using probability proportionate to size sampling method in this community-based cross-sectional study, 22 community health service centers were selected from 10 administrative districts in Shenzhen, China. Approximately 60 T2DM patients were recruited from each center. The participants completed a structural questionnaire, had their venous blood collected, and underwent medical examinations and fundus photography. Logistic regression models were used to identify the risk factors of DR. The classification and regression tree (CART) model was used to calculate the importance of the identified risk factors. RESULTS This study recruited 1097 T2DM patients, 266 of whom were identified as having DR, yielding a prevalence rate of 24.3% (95% confidence interval [CI]: 21.7%-26.9%). Results showed that a longer duration of DM, indoor-type lifestyle, and higher levels of hemoglobin A1c (HbA1c) or urea increased the risk of DR. Patients with HbA1c values ≥7% were about 2.45 times (odds ratio: 2.45; 95% CI: 1.83-3.29) more likely to have DR than their counterparts. The CART model found that the values of variable importance for HbA1c, DM duration, lifestyle (i.e., indoor type), and urea were 48%, 37%, 10%, and 4%, respectively. CONCLUSION The prevalence of DR is high for T2DM patients who receive DM health management services from the primary healthcare system. HbA1c is the most important risk factor for DR. Integration of DR screening and HbA1c testing into the healthcare services for T2DM to reduce vision impairment and blindness is urgently warranted.
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Affiliation(s)
- Ziyang Zhang
- Department of Cardio-Cerebrovascular and Diabetes Prevention and Control, Shenzhen Center for Chronic Disease Control, Shenzhen, Guangdong, China
| | - Deliang Lv
- Department of Cardio-Cerebrovascular and Diabetes Prevention and Control, Shenzhen Center for Chronic Disease Control, Shenzhen, Guangdong, China
| | - Yueyue You
- Department of Cardio-Cerebrovascular and Diabetes Prevention and Control, Shenzhen Center for Chronic Disease Control, Shenzhen, Guangdong, China
| | - Zhiguang Zhao
- Department of Cardio-Cerebrovascular and Diabetes Prevention and Control, Shenzhen Center for Chronic Disease Control, Shenzhen, Guangdong, China
| | - Wei Hu
- Department of Cardio-Cerebrovascular and Diabetes Prevention and Control, Shenzhen Center for Chronic Disease Control, Shenzhen, Guangdong, China
| | - Fengzhu Xie
- Department of Cardio-Cerebrovascular and Diabetes Prevention and Control, Shenzhen Center for Chronic Disease Control, Shenzhen, Guangdong, China
| | - Yali Lin
- Department of Cardio-Cerebrovascular and Diabetes Prevention and Control, Shenzhen Center for Chronic Disease Control, Shenzhen, Guangdong, China
| | - Wei Xie
- Department of Cardio-Cerebrovascular and Diabetes Prevention and Control, Shenzhen Center for Chronic Disease Control, Shenzhen, Guangdong, China
| | - Xiaobing Wu
- Department of Cardio-Cerebrovascular and Diabetes Prevention and Control, Shenzhen Center for Chronic Disease Control, Shenzhen, Guangdong, China
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Mirzababaei A, Abaj F, Roumi Z, Khosroshahi RA, Aali Y, Clark CCT, Radmehr M, Mirzaei K. Consumption of red, white, and processed meat and odds of developing kidney damage and diabetic nephropathy (DN) in women: a case control study. Sci Rep 2024; 14:10344. [PMID: 38710706 DOI: 10.1038/s41598-024-59097-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/30/2023] [Accepted: 04/08/2024] [Indexed: 05/08/2024] Open
Abstract
Diabetic nephropathy (DN) is one of the most prevalent and severe complications of diabetes mellitus (DM) and is associated with increased morbidity and mortality. We aimed to investigate the associations between red, processed, and white meat consumption and the odds of developing kidney damage and DN in women. We enrolled 105 eligible women with DN and 105 controls (30-65 years). A validated and reliable food frequency questionnaire (FFQ) was used to evaluate the consumption of red, processed, and white meat. Biochemical variables and anthropometric measurements were assessed for all patients using pre-defined protocols. Binary logistic regression was conducted to examine possible associations. The results of the present study showed that there was a direct significant association between high consumption of red meat and processed meats and odds of microalbuminuria (red meat 2.30, 95% CI 1.25, 4.22; P-value = 0.007, processed meat: OR 2.16, 95% CI 1.18, 3.95; P-value = 0.01), severe albuminuria (red meat OR 3.25, 95% CI 1.38, 7.46; P-value = 0.007, processed meat: OR 2.35, 95% CI 1.01, 5.49; P-value = 0.04), BUN levels (red meat: OR 2.56, 95% CI 1.10, 5.93; P-value = 0.02, processed meat: OR 2.42, 95% CI 1.04, 5.62; P-value = 0.03), and DN (red meat 2.53, 95% CI 1.45, 4.42; P-value = 0.001, processed meat: OR 2.21; 95% CI 1.27, 3.85; P-value = 0.005). In summary, our study suggests that higher consumption of red and processed meat sources may be associated with microalbuminuria, severe albuminuria, higher BUN level, and higher odds of DN.
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Affiliation(s)
- Atieh Mirzababaei
- Department of Community Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences (TUMS), Tehran, Iran
| | - Faezeh Abaj
- Department of nutrition, Dietetics and food, Monash University, Clayton, Australia
| | - Zahra Roumi
- Department of Nutrition, Electronic Health and Statistics Surveillance Research Center, Science and Research Branch, Islamic Azad University, Tehran, Iran
| | - Reza Amiri Khosroshahi
- Department of Clinical Nutrition School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Islamic Republic of Iran
| | - Yasaman Aali
- Department of Community Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences (TUMS), Tehran, Iran
| | - Cain C T Clark
- Centre for Intelligent Healthcare, Coventry University, Coventry, CV1 5FB, UK
| | - Mina Radmehr
- Department of Nutrition, Science and Research Branch, Islamic Azad University, Tehran, Iran
| | - Khadijeh Mirzaei
- Department of Community Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences (TUMS), Tehran, Iran.
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Modestino MR, Iacono O, Ferrentino L, Lombardi A, De Fortuna U, Verdoliva R, De Luca M, Guardasole V. How should we differentiate hypoglycaemia in non-diabetic patients? J Basic Clin Physiol Pharmacol 2024; 35:111-119. [PMID: 38619602 DOI: 10.1515/jbcpp-2024-0030] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/02/2024] [Accepted: 03/10/2024] [Indexed: 04/16/2024]
Abstract
Hypoglycaemic syndromes are rare in apparently healthy individuals and their diagnosis can be a difficult challenge for clinicians as there are no shared guidelines that suggest how to approach patients with a suspect hypoglycaemic disorder. Since hypoglycaemia symptoms are common and nonspecific, it's necessary to document the Whipple Triad (signs and/or symptoms compatible with hypoglycaemia; relief of symptoms following glucose administration; low plasma glucose levels) before starting any procedure. Once the triad is documented, a meticulous anamnesis and laboratory tests (blood glucose, insulin, proinsulin, C-peptide, β-hydroxybutyrate and anti-insulin antibodies) should be performed. Results can guide the physician towards further specific tests, concerning the suspected disease. In this review, we consider all current causes of hypoglycaemia, including rare diseases such as nesidioblastosis and Hirata's syndrome, describe appropriate tests for diagnosis and suggest strategies to differentiate hypoglycaemia aetiology.
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Affiliation(s)
- Michele R Modestino
- Department of Translational Medical Sciences, 165474 Federico II University Hospital , Napoli, Italy
| | - Olimpia Iacono
- Department of Translational Medical Sciences, 165474 Federico II University Hospital , Napoli, Italy
| | - Laura Ferrentino
- Department of Translational Medical Sciences, 165474 Federico II University Hospital , Napoli, Italy
| | - Anna Lombardi
- Department of Translational Medical Sciences, 165474 Federico II University Hospital , Napoli, Italy
| | - Umberto De Fortuna
- Department of Translational Medical Sciences, 165474 Federico II University Hospital , Napoli, Italy
| | - Rita Verdoliva
- Department of Translational Medical Sciences, 165474 Federico II University Hospital , Napoli, Italy
| | - Mariarosaria De Luca
- Department of Translational Medical Sciences, 165474 Federico II University Hospital , Napoli, Italy
| | - Vincenzo Guardasole
- Department of Translational Medical Sciences, 165474 Federico II University Hospital , Napoli, Italy
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24
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Seo JH, Lee Y. Possible Causal Association between Type 2 Diabetes and Glycaemic Traits in Primary Open-Angle Glaucoma: A Two-Sample Mendelian Randomisation Study. Biomedicines 2024; 12:866. [PMID: 38672220 PMCID: PMC11048047 DOI: 10.3390/biomedicines12040866] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/26/2024] [Revised: 04/03/2024] [Accepted: 04/12/2024] [Indexed: 04/28/2024] Open
Abstract
Existing literature suggests a controversial relationship between type 2 diabetes mellitus (T2D) and glaucoma. This study aimed to examine the potential causal connection between T2D and glycaemic traits (fasting glucose [FG] and glycated haemoglobin [HbA1c] levels) as exposures to primary open-angle glaucoma (POAG) in multi-ethnic populations. Single-nucleotide polymorphisms associated with exposure to T2D, FG, and HbA1c were selected as instrumental variables with significance (p < 5.0 × 10-8) from the genome-wide association study (GWAS)-based meta-analysis data available from the BioBank Japan and the UK Biobank (UKB). The GWAS for POAG was obtained from the meta-analyses of Genetic Epidemiology Research in Adult Health and Aging and the UKB. A two-sample Mendelian randomisation (MR) study was performed to assess the causal estimates using the inverse-variance weighted (IVW) method, and MR-Pleiotropy Residual Sum and Outlier test (MR-PRESSO). Significant causal associations of T2D (odds ratio [OR] = 1.05, 95% confidence interval [CI] = [1.00-1.10], p = 0.031 in IVW; OR = 1.06, 95% CI = [1.01-1.11], p = 0.017 in MR-PRESSO) and FG levels (OR = 1.19, 95% CI = [1.02-1.38], p = 0.026 in IVW; OR = 1.17, 95% CI = [1.01-1.35], p = 0.041 in MR-PRESSO) with POAG were observed, but not in HbA1c (all p > 0.05). The potential causal relationship between T2D or FG and POAG highlights its role in the prevention of POAG. Further investigation is necessary to authenticate these findings.
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Affiliation(s)
- Je Hyun Seo
- Veterans Medical Research Institute, Veterans Health Service Medical Center, Seoul 05368, Republic of Korea;
| | - Young Lee
- Veterans Medical Research Institute, Veterans Health Service Medical Center, Seoul 05368, Republic of Korea;
- Department of Applied Statistics, Chung-Ang University, Seoul 06974, Republic of Korea
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25
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Ikeda T, Komiyama H, Miyakuni T, Takano M, Asai K. Exploring Possible Links: Thigh Muscle Mass, Apolipoproteins, and Glucose Metabolism in Peripheral Artery Disease-Insights from a Pilot Sub-Study following Endovascular Treatment. Metabolites 2024; 14:192. [PMID: 38668320 PMCID: PMC11052193 DOI: 10.3390/metabo14040192] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/01/2024] [Revised: 03/24/2024] [Accepted: 03/27/2024] [Indexed: 04/28/2024] Open
Abstract
Peripheral artery disease (PAD) compromises walking and physical activity, which results in further loss of skeletal muscle. The cross-sectional area of the thigh muscle has been shown to be correlated with systemic skeletal muscle volume. In our previous pilot study, we observed an increase in thigh muscle mass following endovascular treatment (EVT) in patients with proximal vascular lesions affecting the aortoiliac and femoropopliteal arteries. Considering the potential interactions between skeletal muscle, lipid profile, and glucose metabolism, we aimed to investigate the relationship between thigh muscle mass and apolipoproteins as well as glucose metabolism in PAD patients undergoing EVT. This study is a prespecified sub-study conducted as part of a pilot study. We prospectively enrolled 22 symptomatic patients with peripheral artery disease (PAD) and above-the-knee lesions, specifically involving the blood vessels supplying the thigh muscle. The mid-thigh muscle area was measured with computed tomography before and 6 months after undergoing EVT. Concurrently, we measured levels of apolipoproteins A1 (Apo A1) and B (Apo B), fasting blood glucose, 2 h post-load blood glucose (using a 75 g oral glucose tolerance test), and glycated hemoglobin A1c (HbA1c). Changes in thigh muscle area (delta muscle area: 2.5 ± 8.1 cm2) did not show significant correlations with changes in Apo A1, Apo B, fasting glucose, 2 h post-oral glucose tolerance test blood glucose, HbA1c, or Rutherford classification. However, among patients who experienced an increase in thigh muscle area following EVT (delta muscle area: 8.41 ± 5.93 cm2), there was a significant increase in Apo A1 (pre: 121.8 ± 15.1 mg/dL, 6 months: 136.5 ± 19.5 mg/dL, p < 0.001), while Apo B remained unchanged (pre: 76.4 ± 19.2 mg/dL, 6 months: 80.5 ± 4.9 mg/dL). Additionally, post-oral glucose tolerance test 2 h blood glucose levels showed a decrease (pre: 189.7 ± 67.5 mg/dL, 6 months: 170.6 ± 69.7 mg/dL, p = 0.075). Patients who exhibited an increase in thigh muscle area demonstrated more favorable metabolic changes compared to those with a decrease in thigh muscle area (delta muscle area: -4.67 ± 2.41 cm2). This pilot sub-study provides insights into the effects of EVT on thigh muscle, apolipoproteins, and glucose metabolism in patients with PAD and above-the-knee lesions. Further studies are warranted to validate these findings and establish their clinical significance. The trial was registered on the University Hospital Medical Information Network Clinical Trials Registry (UMIN000047534).
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Affiliation(s)
- Takeshi Ikeda
- Cardiovascular Medicine, Nippon Medical School, Tokyo 113-8603, Japan; (T.I.); (K.A.)
| | - Hidenori Komiyama
- Cardiovascular Medicine, Saitama Medical Center, Saitama Medical University, Saitama 350-8550, Japan
| | - Tomoyo Miyakuni
- Cardiovascular Medicine, Nippon Medical School Chiba Hokusoh Hospital, Chiba 270-1613, Japan; (T.M.)
| | - Masamichi Takano
- Cardiovascular Medicine, Nippon Medical School Chiba Hokusoh Hospital, Chiba 270-1613, Japan; (T.M.)
| | - Kuniya Asai
- Cardiovascular Medicine, Nippon Medical School, Tokyo 113-8603, Japan; (T.I.); (K.A.)
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Ahmad SZ, Ivers N, Zenlea I, Parsons JA, Shah BR, Mukerji G, Punthakee Z, Shulman R. An assessment of adaptation and fidelity in the implementation of an audit and feedback-based intervention to improve transition to adult type 1 diabetes care in Ontario, Canada. Implement Sci Commun 2024; 5:25. [PMID: 38500183 PMCID: PMC10946155 DOI: 10.1186/s43058-024-00563-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/18/2023] [Accepted: 03/03/2024] [Indexed: 03/20/2024] Open
Abstract
BACKGROUND The fit between an intervention and its local context may affect its implementation and effectiveness. Researchers have stated that both fidelity (the degree to which an intervention is delivered, enacted, and received as intended) and adaptation to the local context are necessary for high-quality implementation. This study describes the implementation of an audit and feedback (AF)-based intervention to improve transition to type 1 diabetes adult care, at five sites, in terms of adaptation and fidelity. METHODS An audit and feedback (AF)-based intervention for healthcare teams to improve transition to adult care for patients with type 1 diabetes was studied at five pediatric sites. The Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS) was used to document the adaptations made during the study. Fidelity was determined on three different levels: delivery, enactment, and receipt. RESULTS Fidelity of delivery, receipt, and enactment were preserved during the implementation of the intervention. Of the five sites, three changed their chosen quality improvement initiative, however, within the parameters of the study protocol; therefore, fidelity was preserved while still enabling participants to adapt accordingly. CONCLUSIONS We describe implementing a multi-center AF-based intervention across five sites in Ontario to improve the transition from pediatric to adult diabetes care for youth with type 1 diabetes. This intervention adopted a balanced approach considering both adaptation and fidelity to foster a community of practice to facilitate implementing quality improvement initiatives for improving transition to adult diabetes care. This approach may be adapted for improving transition care for youth with other chronic conditions and to other complex AF-based interventions. TRIAL REGISTRATION ClinicalTrials.gov NCT03781973. Registered 13 December 2018. Date of enrolment of the first participant to the trial: June 1, 2019.
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Affiliation(s)
- Syed Zain Ahmad
- Institute of Medical Science, Temerty Faculty of Medicine, University of Toronto, Toronto, Canada
- SickKids Research Institute, Toronto, Canada
| | - Noah Ivers
- Women's College Institute for Health System Solutions and Virtual Care, Toronto, Canada
- Department of Family Medicine, Women's College Hospital, University of Toronto, Toronto, Canada
| | - Ian Zenlea
- Institute for Better Health, Trillium Health Partners, Mississauga, Canada
| | - Janet A Parsons
- Department of Occupational Science & Occupational Therapy, Temerty Faculty of Medicine, University of Toronto, Toronto, Canada
- Li Ka Shing Knowledge Institute, St. Michael's Hospital, Unity Health Toronto, Toronto, Canada
| | - Baiju R Shah
- Department of Medicine, Temerty Faculty of Medicine, University of Toronto, Toronto, Canada
- Division of Endocrinology, Sunnybrook Health Sciences Centre, Toronto, Canada
- ICES, Toronto, Canada
| | - Geetha Mukerji
- Department of Medicine, Temerty Faculty of Medicine, University of Toronto, Toronto, Canada
- Women's College Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, Toronto, Canada
| | - Zubin Punthakee
- Department of Medicine, McMaster University, Hamilton, Canada
| | - Rayzel Shulman
- Institute of Medical Science, Temerty Faculty of Medicine, University of Toronto, Toronto, Canada.
- SickKids Research Institute, Toronto, Canada.
- Department of Medicine, Temerty Faculty of Medicine, University of Toronto, Toronto, Canada.
- Division of Endocrinology, The Hospital for Sick Children, Toronto, Canada.
- Department of Pediatrics, University of Toronto, Toronto, Canada.
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27
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Villa-Tamayo MF, Colmegna P, Breton MD. Integration of a Safety Module to Prevent Rebound Hypoglycemia in Closed-Loop Artificial Pancreas Systems. J Diabetes Sci Technol 2024; 18:318-323. [PMID: 37966051 PMCID: PMC10973857 DOI: 10.1177/19322968231212205] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/16/2023]
Abstract
BACKGROUND With automated insulin delivery (AID) systems becoming widely adopted in the management of type 1 diabetes, we have seen an increase in occurrences of rebound hypoglycemia or generated hypoglycemia induced by the controller's response to rapid glucose rises following rescue carbohydrates. Furthermore, as AID systems aim to enable complete automation of prandial control, algorithms are designed to react even more strongly to glycemic rises. This work introduces a rebound hypoglycemia prevention layer (HypoSafe) that can be easily integrated into any AID system. METHODS HypoSafe constrains the maximum permissible insulin delivery dose based on the minimum glucose reading from the previous hour and the current glucose level. To demonstrate its efficacy, we integrated HypoSafe into the latest University of Virginia (UVA) AID system and simulated two scenarios using the 100-adult cohort of the UVA/Padova T1D simulator: a nominal case including three unannounced meals, and another case where hypoglycemia was purposely induced by an overestimated manual bolus. RESULTS In both simulation scenarios, rebound hypoglycemia events were reduced with HypoSafe (nominal: from 39 to 0, hypo-induced: from 55 to 7) by attenuating the commanded basal (nominal: 0.27U vs. 0.04U, hypo-induced: 0.27U vs. 0.03U) and bolus (nominal: 1.02U vs. 0.05U, hypo-induced: 0.43U vs. 0.02U) within the 30-minute interval after treating a hypoglycemia event. No clinically significant changes resulted for time in the range of 70 to 180 mg/dL or above 180 mg/dL. CONCLUSION HypoSafe was shown to be effective in reducing rebound hypoglycemia events without affecting achieved time in range when combined with an advanced AID system.
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Affiliation(s)
| | - Patricio Colmegna
- Center for Diabetes Technology,
University of Virginia, Charlottesville, VA, USA
| | - Marc D. Breton
- Center for Diabetes Technology,
University of Virginia, Charlottesville, VA, USA
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Le TQ, Thanh KM, Tran TV, Nguyen DTB, Nguyen LT, Pham DT, Dam LTP, Hoang MT, Huynh TQ. The Correlation Between Glycation Gap and Renal Complications in Patients with Type 2 Diabetes Mellitus. Diabetes Metab Syndr Obes 2024; 17:333-341. [PMID: 38283633 PMCID: PMC10821664 DOI: 10.2147/dmso.s439800] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/16/2023] [Accepted: 01/16/2024] [Indexed: 01/30/2024] Open
Abstract
Purpose The aim of this study was to investigate the correlations between the glycation gap (GG) and renal complications such as urinary albumin-creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR) in type 2 diabetes mellitus patients. Materials and Methods A cross-sectional study was conducted on 104 individuals (52 males and 52 females), aged 36-93 years old. Fasting blood glucose (FBG), HbA1c, and serum fructosamine were measured simultaneously. GG was calculated as the difference between the measured and fructosamine-based predicted HbA1c levels (FHbA1c). Results There was a moderately positive correlation between HbA1c and fructosamine concentration (r = 0.488; p < 0.001). GG was positively correlated with UACR (r = 0.3275; p = 0.0007), negatively correlated with eGFR (r = -0.3400; p = 0.0004). HbA1c was positively correlated with UACR (r = 0.2437; p = 0.0127) but not correlated with eGFR (r = -0.444; p = 0.6542). Fructosamine has a positive correlation with eGFR (r = 0.2426; p = 0.0131) but not with UACR (r = -0.1021; p = 0.3025). Conclusion GG was positively correlated with UACR and inversely correlated with eGFR in type 2 Diabetes mellitus patients. This suggests that GG is a valuable index for predicting kidney complications due to diabetes.
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Affiliation(s)
- Tuan Quoc Le
- Department of Physiology-Pathophysiology-Immunology, Faculty of Medicine, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam
| | - Khanh Minh Thanh
- Department of Physiology-Pathophysiology-Immunology, Faculty of Medicine, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam
| | - Tien Van Tran
- Department of Nephrology, Ho Chi Minh City Hospital for Rehabilitation - Professional Diseases, Ho Chi Minh City, Vietnam
| | | | - Le Thi Nguyen
- Nephrology Department, University Medical Center, Ho Chi Minh City, Vietnam
| | - Diep Thao Pham
- Biochemistry Department, Viet Duc Hospital, Ha Noi, Vietnam
| | - Lan Thi Phuong Dam
- Biochemistry Department, 103 Military Medical Hospital, Vietnam Military Medical University (VMMU), Ha Noi City, Vietnam
| | - Minh Thị Hoang
- Biochemistry Department, 103 Military Medical Hospital, Vietnam Military Medical University (VMMU), Ha Noi City, Vietnam
| | - Thuan Quang Huynh
- Biochemistry Department, 103 Military Medical Hospital, Vietnam Military Medical University (VMMU), Ha Noi City, Vietnam
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Sousa S, Pereira AM, Santiago LM. Patient-Centered Medicine and Self-Care of Patients with Type 2 Diabetes: A Cross-Sectional Study. ACTA MEDICA PORT 2024; 37:3-9. [PMID: 37000414 DOI: 10.20344/amp.18584] [Citation(s) in RCA: 2] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/18/2022] [Accepted: 12/12/2022] [Indexed: 04/01/2023]
Abstract
INTRODUCTION Even though the prevalence rate of diabetes in Portugal is one of the highest in Europe, no studies on the association between patient centered medicine, diabetes self-care, and glycemic control have been published. Assuming that patient centered medicine increases adherence to treatment through the improvement of the doctor-patient relationship, the aim of this study was to assess the influence of patient-centered medicine on the self-care of patients with type 2 diabetes patients' (T2DM) in two Family Health Units in Central Portugal, according to gender and age. MATERIAL AND METHODS A cross-sectional study was conducted in two Family Health Units in Central Portugal between the 25th November 2021 and the 15th January 2022. Patients with type 2 diabetes were invited to fill in the Patient-Centered Medicine questionnaire, for patients (PCM-p) (where higher values represent worse results) and the Summary of Diabetes Self-Care Activities Measure (SDSCAM), (where higher values represent better results), while healthcare professionals filled in the epidemiologic variables on pre-defined days. RESULTS A sample of 298 patients with type 2 diabetes was studied. Linear regressions for the association between SDSCAM scale factors and PCM-p showed significant associations for general diet (β = -0.07, p < 0.001), specific diet (β = -0.10, p < 0.001), exercise (β = -0.03, p = 0.008), foot care (β = -0.11, p < 0.001) and medication adherence in general (β = -0.06, p = 0.001). Multiple linear regression including the association between glycated hemoglobin (HbA1c) and the SDSCAM scale dimensions showed that specific diet was associated with lower HbA1c levels (β = -0.01, p = 0.007) and blood sugar testing (β = 0.01, p < 0.001) and that a higher score in PCMp was associated with higher HbA1c levels (β = 0.06, p < 0.001). Male patients (β = -6.93, p = 0.007) and older patients (β = -0.42, p = 0.001) were associated with lower scores in the specific diet. The male gender was associated with higher scores in exercise (β = 7.62, p = 0.029), lower scores in foot care (β = -6.06, p = 0.029) and lower scores in medication adherence to injectable medicines/6.2 (β = -0.73, p = 0.018). Age was associated with a lower score in medication (β = -0.03, p = 0.045) and a higher PCMp total score (β = 0.07, p = 0.030). CONCLUSION Patient-centered medicine in type 2 diabetics is associated with better self-care behaviors in patients with type 2 diabetes. Gender and age differences were observed in self-care behaviors and age differences were observed in Patient Centered Medicine.
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Affiliation(s)
- Solange Sousa
- Faculdade de Medicina. Universidade de Coimbra. Coimbra. Portugal
| | - Albino Miguel Pereira
- Mondego Family Health Unit; General Practice Clinic. Faculdade de Medicina. Universidade de Coimbra. Coimbra. Portugal
| | - Luiz Miguel Santiago
- General Practice Clinic. Faculdade de Medicina. Universidade de Coimbra. Coimbra. Portugal
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Capellan P, Dillon AB, Rodriguez G, Chua J, Abdallah Mahrous M, Kovacs K, Van Tassel S, D’Amico DJ, Kiss S, Orlin A. Implementation of a Teleophthalmology Screening Program for Diabetic Retinopathy in New York City. JOURNAL OF VITREORETINAL DISEASES 2024; 8:34-44. [PMID: 38223768 PMCID: PMC10786072 DOI: 10.1177/24741264231208253] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/16/2024]
Abstract
Purpose: To examine the implementation of a teleophthalmology program for diabetic retinopathy (DR) screening at a metropolitan hospital system and identify the challenges that the clinical teams encountered using the program. Methods: The study was conducted in 2 parts. The first was a pilot retrospective chart review of 300 consecutive patients screened for DR by the teleophthalmology screening program. The baseline variables, DR capture rate and staging, and continuity of care for those diagnosed with DR were analyzed. The second was a web-based survey identifying the barriers encountered by 36 physicians and clinical staff as they participated in the teleophthalmology screening program. Results: Part 1: Of the patients evaluated, 57 (19.0%) were diagnosed with DR; 42 (73.7%) had mild nonproliferative DR (NPDR), 7 (12.3%) had moderate NPDR, none had severe NPDR, and 8 (14.0%) had PDR. Thirty-one patients (54.4%) with retinopathy diagnoses were referred for an in-person follow-up at the clinic while the rest continued monitoring via the program. Of this subset, 22 (71.0%) completed the follow-up visit. Part 2: The survey respondents comprised 28 physicians (77.8%), 6 licensed nurse practitioners (16.7%), and 2 medical assistants (5.6%). Twenty-two providers (71.0%) preferred initiating referrals for in-person annual examinations over teleophthalmology screening referrals. The most common barriers described were related to workflow interruption, time constraints, and staff shortages. Conclusions: The teleophthalmology DR screening program allowed identification of early or absent DR at clinics in an urban setting (New York City). The findings suggest areas for targeted improvement in the screening program to better complement internal referral practices' workflows.
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Affiliation(s)
- Pamela Capellan
- Department of Ophthalmology, Retina Service, Weill Cornell Medical College, New York, NY, USA
| | - Alexander B. Dillon
- Department of Ophthalmology, UCLA Jules Stein Eye Institute, Los Angeles, CA, USA
| | | | - Jason Chua
- Division of Biostatistics, Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA
| | - M. Abdallah Mahrous
- Department of Ophthalmology, Retina Service, Weill Cornell Medical College, New York, NY, USA
| | - Kyle Kovacs
- Department of Ophthalmology, Retina Service, Weill Cornell Medical College, New York, NY, USA
| | - Sarah Van Tassel
- Department of Ophthalmology, Retina Service, Weill Cornell Medical College, New York, NY, USA
| | - Donald J. D’Amico
- Department of Ophthalmology, Retina Service, Weill Cornell Medical College, New York, NY, USA
| | - Szilard Kiss
- Department of Ophthalmology, Retina Service, Weill Cornell Medical College, New York, NY, USA
| | - Anton Orlin
- Department of Ophthalmology, Retina Service, Weill Cornell Medical College, New York, NY, USA
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Ratzki-Leewing A, Black JE, Kahkoska AR, Ryan BL, Zou G, Klar N, Timcevska K, Harris SB. Severe (level 3) hypoglycaemia occurrence in a real-world cohort of adults with type 1 or 2 diabetes mellitus (iNPHORM, United States). Diabetes Obes Metab 2023; 25:3736-3747. [PMID: 37700692 PMCID: PMC10958739 DOI: 10.1111/dom.15268] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/28/2023] [Revised: 08/17/2023] [Accepted: 08/18/2023] [Indexed: 09/14/2023]
Abstract
AIMS Among adults with insulin- and/or secretagogue-treated diabetes in the United States, very little is known about the real-world descriptive epidemiology of iatrogenic severe (level 3) hypoglycaemia. Addressing this gap, we collected primary, longitudinal data to quantify the absolute frequency of events as well as incidence rates and proportions. MATERIALS AND METHODS iNPHORM is a US-wide, 12-month ambidirectional panel survey (2020-2021). Adults with type 1 diabetes mellitus (T1DM) or insulin- and/or secretagogue-treated type 2 diabetes mellitus (T2DM) were recruited from a probability-based internet panel. Participants completing ≥1 follow-up questionnaire(s) were analysed. RESULTS Among 978 respondents [T1DM 17%; mean age 51 (SD 14.3) years; male: 49.6%], 63% of level 3 events were treated outside the health care system (e.g. by family/friend/colleague), and <5% required hospitalization. Following the 12-month prospective period, one-third of individuals reported ≥1 event(s) [T1DM 44.2% (95% CI 36.8%-51.8%); T2DM 30.8% (95% CI 28.7%-35.1%), p = .0404, α = 0.0007]; and the incidence rate was 5.01 (95% CI 4.15-6.05) events per person-year (EPPY) [T1DM 3.57 (95% CI 2.49-5.11) EPPY; T2DM 5.29 (95% CI 4.26-6.57) EPPY, p = .1352, α = 0.0007]. Level 3 hypoglycaemia requiring non-transport emergency medical services was more common in T2DM than T1DM (p < .0001, α = 0.0016). In total, >90% of events were experienced by <15% of participants. CONCLUSIONS iNPHORM is one of the first long-term, prospective US-based investigations on level 3 hypoglycaemia epidemiology. Our results underscore the importance of participant-reported data to ascertain its burden. Events were alarmingly frequent, irrespective of diabetes type, and concentrated in a small subsample.
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Affiliation(s)
- Alexandria Ratzki-Leewing
- Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada
- Department of Family Medicine, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada
| | - Jason E. Black
- Department of Family Medicine, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada
| | - Anna R. Kahkoska
- Department of Nutrition, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, USA
| | - Bridget L. Ryan
- Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada
- Department of Family Medicine, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada
| | - Guangyong Zou
- Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada
- Robarts Research Institute, Western University, London, Ontario, Canada
| | - Neil Klar
- Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada
| | - Kristina Timcevska
- Department of Family Medicine, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada
| | - Stewart B. Harris
- Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada
- Department of Family Medicine, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada
- Department of Medicine/Division of Endocrinology, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada
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Campbell MD, Alobaid AM, Hopkins M, Dempsey PC, Pearson SM, Kietsiriroje N, Churm R, Ajjan RA. Interrupting prolonged sitting with frequent short bouts of light-intensity activity in people with type 1 diabetes improves glycaemic control without increasing hypoglycaemia: The SIT-LESS randomised controlled trial. Diabetes Obes Metab 2023; 25:3589-3598. [PMID: 37622406 DOI: 10.1111/dom.15254] [Citation(s) in RCA: 8] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/26/2023] [Revised: 07/31/2023] [Accepted: 08/08/2023] [Indexed: 08/26/2023]
Abstract
AIM To examine the impact of interrupting prolonged sitting with frequent short bouts of light-intensity activity on glycaemic control in people with type 1 diabetes (T1D). MATERIALS AND METHODS In total, 32 inactive adults with T1D [aged 27.9 ± 4.7 years, 15 men, diabetes duration 16.0 ± 6.9 years and glycated haemoglobin 8.4 ± 1.4% (68 ± 2.3 mmol/mol)] underwent two 7-h experimental conditions in a randomised crossover fashion with >7-day washout consisting of: uninterrupted sitting (SIT), or, interrupted sitting with 3-min bouts of self-paced walking at 30-min intervals (SIT-LESS). Standardised mixed-macronutrient meals were administered 3.5 h apart during each condition. Blinded continuous glucose monitoring captured interstitial glucose responses during the 7-h experimental period and for a further 48-h under free-living conditions. RESULTS SIT-LESS reduced total mean glucose (SIT 8.2 ± 2.6 vs. SIT-LESS 6.9 ± 1.7 mmol/L, p = .001) and increased time in range (3.9-10.0 mmol/L) by 13.7% (SIT 71.5 ± 9.5 vs. SIT-LESS 85.1 ± 7.1%, p = .002). Hyperglycaemia (>10.0 mmol/L) was reduced by 15.0% under SIT-LESS (SIT 24.2 ± 10.8 vs. SIT-LESS 9.2 ± 6.4%, p = .002), whereas hypoglycaemia exposure (<3.9 mmol/L) (SIT 4.6 ± 3.0 vs. SIT-LESS 6.0 ± 6.0%, p = .583) was comparable across conditions. SIT-LESS reduced glycaemic variability (coefficient of variation %) by 7.8% across the observation window (p = .021). These findings were consistent when assessing discrete time periods, with SIT-LESS improving experimental and free-living postprandial, whole-day and night-time glycaemic outcomes (p < .05). CONCLUSIONS Interrupting prolonged sitting with frequent short bouts of light-intensity activity improves acute postprandial and 48-h glycaemia in adults with T1D. This pragmatic strategy is an efficacious approach to reducing sedentariness and increasing physical activity levels without increasing risk of hypoglycaemia in T1D.
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Affiliation(s)
- Matthew D Campbell
- John Dawson Drug Discovery and Development Institute, University of Sunderland, Sunderland, UK
- Leeds Institute of Cardiovascular and Metabolic Medicine, Faculty of Medicine, University of Leeds, Leeds, UK
- Institute of Metabolic Science, University of Cambridge, Cambridge, UK
| | - Anwar M Alobaid
- School of Food Science and Nutrition, Faculty of Environment, University of Leeds, Leeds, UK
- Ministry of Health, Farwaniya Hospital, Kuwait, Kuwait
| | - Mark Hopkins
- School of Food Science and Nutrition, Faculty of Environment, University of Leeds, Leeds, UK
| | - Paddy C Dempsey
- Institute of Metabolic Science, University of Cambridge, Cambridge, UK
- Diabetes Research Centre, University of Leicester, Leicester, UK
- Baker Heart and Diabetes Institute, Melbourne, Australia
- Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Victoria, Australia
| | - Sam M Pearson
- Leeds Institute of Cardiovascular and Metabolic Medicine, Faculty of Medicine, University of Leeds, Leeds, UK
| | - Noppadol Kietsiriroje
- Leeds Institute of Cardiovascular and Metabolic Medicine, Faculty of Medicine, University of Leeds, Leeds, UK
- Endocrinology and Metabolism Unit, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand
| | - Rachel Churm
- Applied Sports Technology, Exercise and Medicine (A-STEM) Research Centre, Faculty of Science and Engineering, Swansea University, Swansea, UK
| | - Ramzi A Ajjan
- Leeds Institute of Cardiovascular and Metabolic Medicine, Faculty of Medicine, University of Leeds, Leeds, UK
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Roberts G, Chang L, Park JM, Thynne T. The occurrence of Hospital-Acquired Pneumonia is independently associated with elevated Stress Hyperglycaemia Ratio at admission but not elevated blood glucose. Diabetes Res Clin Pract 2023; 205:110955. [PMID: 37839754 DOI: 10.1016/j.diabres.2023.110955] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/07/2023] [Revised: 10/02/2023] [Accepted: 10/13/2023] [Indexed: 10/17/2023]
Abstract
BACKGROUND The association between stress-induced hyperglycaemia (SIH) and increased infection rates in hospitalised subjects is well-known. It is less clear if SIH at admission independently drives new-onset infections. We assessed the relationship between early exposure at admission to both the Stress Hyperglycaemia Ratio (SHR) and Blood Glucose (BG) with Hospital-Acquired Pneumonia (HAP). METHODS This observational retrospective study included those with length-of-stay > 1 day, BG within 24 h of admission and recent haemoglobin A1c. SIH was defined as BG ≥ 10 mmol/L, or SHR ≥ 1.1, measured at both admission and as a 24-hour maximum. Multivariable analyses were adjusted for length-of-stay, age, mechanical ventilation, and chronic respiratory disease. RESULTS Of 5,339 eligible subjects, 110 (2.1%) experienced HAP. Admission SHR ≥ 1.1 was independently associated with HAP (OR 3.04, 95% CI 1.98-4.68, p < 0.0001) but not BG ≥ 10 mmol/L (OR 0.65, 95% CI 0.41-1.03, p = 0.0675). The association with SHR strengthened using maximum 24-hour values (OR 3.37, 95% CI 2.05-5.52, p < 0.0001) while BG ≥ 10 mmol/L remained insignificant (OR 0.96, 95% CI 0.63-1.46, p = 0.86). Of those experiencing HAP 40 (36.4%) occurred in subjects with no recorded BG ≥ 10 mmol/L but SHR ≥ 1.1. CONCLUSION SIH at admission defined as SHR ≥ 1.1, but not the conventional marker of BG ≥ 10 mmol/L, was independently associated with the subsequent onset of HAP, commonly at BG < 10 mmol/L.
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Affiliation(s)
- Gregory Roberts
- SA Pharmacy, Flinders Medical Centre, Bedford Park SA 5042, Australia; College of Medicine and Public Health, Flinders University, Bedford Park SA 5042, Australia.
| | - Leonard Chang
- College of Medicine and Public Health, Flinders University, Bedford Park SA 5042, Australia.
| | - Joong-Min Park
- College of Medicine and Public Health, Flinders University, Bedford Park SA 5042, Australia.
| | - Tilenka Thynne
- College of Medicine and Public Health, Flinders University, Bedford Park SA 5042, Australia; Department of Clinical Pharmacology, Flinders Medical Centre, Bedford Park SA 5042, Australia.
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Kistkins S, Mihailovs T, Lobanovs S, Pīrāgs V, Sourij H, Moser O, Bļizņuks D. Comparative Analysis of Predictive Interstitial Glucose Level Classification Models. SENSORS (BASEL, SWITZERLAND) 2023; 23:8269. [PMID: 37837098 PMCID: PMC10574913 DOI: 10.3390/s23198269] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 09/07/2023] [Revised: 10/02/2023] [Accepted: 10/04/2023] [Indexed: 10/15/2023]
Abstract
BACKGROUND New methods of continuous glucose monitoring (CGM) provide real-time alerts for hypoglycemia, hyperglycemia, and rapid fluctuations of glucose levels, thereby improving glycemic control, which is especially crucial during meals and physical activity. However, complex CGM systems pose challenges for individuals with diabetes and healthcare professionals, particularly when interpreting rapid glucose level changes, dealing with sensor delays (approximately a 10 min difference between interstitial and plasma glucose readings), and addressing potential malfunctions. The development of advanced predictive glucose level classification models becomes imperative for optimizing insulin dosing and managing daily activities. METHODS The aim of this study was to investigate the efficacy of three different predictive models for the glucose level classification: (1) an autoregressive integrated moving average model (ARIMA), (2) logistic regression, and (3) long short-term memory networks (LSTM). The performance of these models was evaluated in predicting hypoglycemia (<70 mg/dL), euglycemia (70-180 mg/dL), and hyperglycemia (>180 mg/dL) classes 15 min and 1 h ahead. More specifically, the confusion matrices were obtained and metrics such as precision, recall, and accuracy were computed for each model at each predictive horizon. RESULTS As expected, ARIMA underperformed the other models in predicting hyper- and hypoglycemia classes for both the 15 min and 1 h horizons. For the 15 min forecast horizon, the performance of logistic regression was the highest of all the models for all glycemia classes, with recall rates of 96% for hyper, 91% for norm, and 98% for hypoglycemia. For the 1 h forecast horizon, the LSTM model turned out to be the best for hyper- and hypoglycemia classes, achieving recall values of 85% and 87% respectively. CONCLUSIONS Our findings suggest that different models may have varying strengths and weaknesses in predicting glucose level classes, and the choice of model should be carefully considered based on the specific requirements and context of the clinical application. The logistic regression model proved to be more accurate for the next 15 min, particularly in predicting hypoglycemia. However, the LSTM model outperformed logistic regression in predicting glucose level class for the next hour. Future research could explore hybrid models or ensemble approaches that combine the strengths of multiple models to further enhance the accuracy and reliability of glucose predictions.
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Affiliation(s)
- Svjatoslavs Kistkins
- Research Institute of Pauls Stradins Clinical University Hospital, LV-1002 Riga, Latvia; (S.K.); (V.P.)
| | - Timurs Mihailovs
- Institute of Smart Computing Technologies, Riga Technical University, LV-1048 Riga, Latvia; (T.M.); (D.B.)
| | - Sergejs Lobanovs
- Research Institute of Pauls Stradins Clinical University Hospital, LV-1002 Riga, Latvia; (S.K.); (V.P.)
| | - Valdis Pīrāgs
- Research Institute of Pauls Stradins Clinical University Hospital, LV-1002 Riga, Latvia; (S.K.); (V.P.)
| | - Harald Sourij
- Interdisciplinary Metabolic Medicine Trials Unit, Division of Endocrinology and Diabetology, Medical University of Graz, 8010 Graz, Austria;
| | - Othmar Moser
- Division of Exercise Physiology and Metabolism, Institute of Sport Science, University of Bayreuth, 95447 Bayreuth, Germany;
| | - Dmitrijs Bļizņuks
- Institute of Smart Computing Technologies, Riga Technical University, LV-1048 Riga, Latvia; (T.M.); (D.B.)
- SIA “R4U”, LV-1016 Riga, Latvia
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Ratzki-Leewing AA, Black JE, Ryan BL, Zou G, Klar N, Webster-Bogaert S, Timcevska K, Harris SB. Development and validation of a real-world model to predict 1-year Level 3 (severe) hypoglycaemia risk in adults with diabetes (the iNPHORM study, United States). Diabetes Obes Metab 2023; 25:2910-2927. [PMID: 37409569 DOI: 10.1111/dom.15186] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/24/2023] [Revised: 05/21/2023] [Accepted: 06/01/2023] [Indexed: 07/07/2023]
Abstract
AIMS We aimed to develop and internally validate a real-world prognostic model for Level 3 hypoglycaemia risk compatible with outpatient care in the United States. MATERIALS AND METHODS iNPHORM is a 12-month, US-based panel survey. Adults (18-90 years old) with type 1 diabetes mellitus or insulin- and/or secretagogue-treated type 2 diabetes mellitus were recruited from a nationwide, probability-based internet panel. Among participants completing ≥ 1 follow-up questionnaire(s), we modelled 1-year Level 3 hypoglycaemia risk using Andersen and Gill's Cox survival and penalized regression with multiple imputation. Candidate variables were selected for their clinical relevance and ease of capture at point-of-care. RESULTS In total, 986 participants [type 1 diabetes mellitus: 17%; men: 49.6%; mean age: 51 (SD: 14.3) years] were analysed. Across follow-up, 035.1 (95% CI: 32.2-38.1)% reported ≥1 Level 3 event(s), and the rate was 5.0 (95% CI: 4.1-6.0) events per person-year. Our final model showed strong discriminative validity and parsimony (optimism corrected c-statistic: 0.77). Numerous variables were selected: age; sex; body mass index; marital status; level of education; insurance coverage; race; ethnicity; food insecurity; diabetes type; glycated haemoglobin value; glycated haemoglobin variability; number, type and dose of various medications; number of SH events requiring hospital care (past year and over follow-up); type and number of comorbidities and complications; number of diabetes-related health care visits (past year); use of continuous/flash glucose monitoring; and general health status. CONCLUSIONS iNPHORM is the first US-based primary prognostic study on Level 3 hypoglycaemia. Future model implementation could potentiate risk-tailored strategies that reduce real-world event occurrence and overall diabetes burden.
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Affiliation(s)
- Alexandria A Ratzki-Leewing
- Department of Family Medicine, Schulich School of Medicine and Dentistry, Western University, London, Canada
| | - Jason E Black
- Department of Family Medicine, Schulich School of Medicine and Dentistry, Western University, London, Canada
| | - Bridget L Ryan
- Department of Family Medicine, Schulich School of Medicine and Dentistry, Western University, London, Canada
- Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, Canada
| | - Guangyong Zou
- Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, Canada
- Robarts Research Institute, Western University, London, Canada
| | - Neil Klar
- Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, Canada
| | - Susan Webster-Bogaert
- Department of Family Medicine, Schulich School of Medicine and Dentistry, Western University, London, Canada
| | - Kristina Timcevska
- Department of Family Medicine, Schulich School of Medicine and Dentistry, Western University, London, Canada
| | - Stewart B Harris
- Department of Family Medicine, Schulich School of Medicine and Dentistry, Western University, London, Canada
- Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, Canada
- Department of Medicine, Schulich School of Medicine and Dentistry, Western University, London, Canada
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Saxena AR, Frias JP, Gorman DN, Lopez RN, Andrawis N, Tsamandouras N, Birnbaum MJ. Tolerability, safety and pharmacodynamics of oral, small-molecule glucagon-like peptide-1 receptor agonist danuglipron for type 2 diabetes: A 12-week, randomized, placebo-controlled, Phase 2 study comparing different dose-escalation schemes. Diabetes Obes Metab 2023; 25:2805-2814. [PMID: 37311722 DOI: 10.1111/dom.15168] [Citation(s) in RCA: 16] [Impact Index Per Article: 8.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/23/2023] [Revised: 05/16/2023] [Accepted: 05/24/2023] [Indexed: 06/15/2023]
Abstract
AIM To evaluate the tolerability, safety and pharmacodynamics of different dose-escalation schemes of the oral small-molecule glucagon-like peptide-1 receptor (GLP-1R) agonist danuglipron. MATERIALS AND METHODS This Phase 2a, double-blind, placebo-controlled, parallel-group study randomly assigned adults with type 2 diabetes (T2D) treated with metformin to placebo or danuglipron (low [5-mg] or high [10-mg] starting dose, with 1- or 2-week dose-escalation steps, to target doses of 80, 120 or 200 mg twice daily [BID]) and adults with obesity without diabetes to placebo or danuglipron 200 mg BID. RESULTS Participants with T2D (n = 123, mean glycated haemoglobin [HbA1c] 8.19%) or obesity without diabetes (n = 28, mean body mass index 37.3 kg/m2 ) were randomly assigned and treated. Discontinuation from study medication occurred in 27.3% to 72.7% of participants across danuglipron groups versus 16.7% to 18.8% for placebo, most often due to adverse events. Nausea (20.0%-47.6% of participants across danuglipron groups vs. 12.5% for placebo) and vomiting (18.2%-40.9% danuglipron vs. 12.5% placebo, respectively) were most commonly reported in participants with T2D. Gastrointestinal adverse events were generally related to danuglipron target dose and were not substantially affected by starting dose. In participants with T2D, least squares mean changes from baseline in HbA1c (-1.04% to -1.57% across danuglipron groups vs. -0.32% for placebo), fasting plasma glucose (-23.34 mg/dL to -53.94 mg/dL danuglipron vs. -13.09 mg/dL placebo) and body weight (-1.93 to -5.38 kg danuglipron vs. -0.42 kg placebo) at Week 12 were generally statistically significant for danuglipron compared with placebo (P < 0.05). CONCLUSIONS Danuglipron resulted in statistically significant reductions in HbA1c, FPG and body weight over 12 weeks, in the setting of higher discontinuation rates and incidence of gastrointestinal adverse events with higher target doses. CLINICALTRIALS gov identifier: NCT04617275.
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Affiliation(s)
- Aditi R Saxena
- Internal Medicine Research Unit, Pfizer Worldwide Research, Development, and Medical, Cambridge, Massachusetts, USA
| | - Juan P Frias
- Velocity Clinical Research, Los Angeles, California, USA
| | - Donal N Gorman
- Early Clinical Development, Pfizer Worldwide Research and Development, and Medical, Cambridge, UK
| | - Rene N Lopez
- Early Clinical Development, Pfizer Worldwide Research and Development, and Medical, Groton, Connecticut, USA
| | - Nabil Andrawis
- Manassas Clinical Research Center, Manassas, Virginia, USA
| | - Nikolaos Tsamandouras
- Early Clinical Development, Pfizer Worldwide Research and Development, and Medical, Cambridge, Massachusetts, USA
| | - Morris J Birnbaum
- Internal Medicine Research Unit, Pfizer Worldwide Research, Development, and Medical, Cambridge, Massachusetts, USA
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Zafar A, Albakr A, Shahid R, Alkhamis F, Alabdali M, Aljaafari D, Nazish S, AlShamrani FJG, Shariff E, Zeeshan M, AlSulaiman A, AlAmri AS, Aldehailan AS, Al-Jehani H. Association between glycated hemoglobin and functional outcomes in patients with intracranial large artery atherosclerotic disease-related acute ischemic stroke: identifying the magic number. Front Neurol 2023; 14:1249535. [PMID: 37830089 PMCID: PMC10564994 DOI: 10.3389/fneur.2023.1249535] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/28/2023] [Accepted: 09/05/2023] [Indexed: 10/14/2023] Open
Abstract
Objective This study aimed to investigate the effect of the glycated hemoglobin A1c (HbA1c) level on the functional outcome (FOC) in patients with intracranial large artery atherosclerotic disease (ICLAD)-related acute ischemic stroke (AIS). Methods This retrospective study enrolled patients with ICLAD-related AIS who were admitted to King Fahd University Hospital between January 2017 and September 2021. Patients were divided into two groups based on the optimal cutoff HbA1c level determined using receiver operating characteristic curve analysis-those with HbA1c ≤6.9% and those with HbA1c >6.9%. Demographic and other clinical characteristics were compared between the two groups using chi-square tests. The association between HbA1c and 90-day FOC was assessed using the chi-square test and odds ratios (ORs). Multivariate analysis was performed to adjust for confounding factors. Results A total of 140 patients were included in the analysis. A significant association was observed between the HbA1c level and FOC. Compared to patients with HbA1c ≤6.9%, patients with HbA1c >6.9% were more likely to have an unfavorable FOC [p = <0.001, OR = 2.05, 95% confidence interval (CI) = 1.33-3.14]. The association between HbA1c >6.9% and unfavorable FOC was sustained even after adjusting for confounding factors (p = 0.008) and atherosclerosis risk factors (p = 0.01). HbA1c >6.9% was also associated with higher ORs for in-hospital complications (p = 0.06, OR = 1.34, 95% CI = 1.02-1.77) and mortality (p = 0.07, OR = 1.42, 95% CI = 1.06-1.92) although these associations did not attain significant p-values. Conclusion HbA1c >6.9% was significantly associated with unfavorable FOC in ICLAD-related AIS. However, further studies with larger sample sizes are required to verify whether HbA1c is an independent predictor of poor FOC. Nevertheless, targeting HbA1c <7% should be the goal of physicians when managing patients at high risk of ICLAD.
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Affiliation(s)
- Azra Zafar
- Department of Neurology, College of Medicine, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia
| | - Aishah Albakr
- Department of Neurology, College of Medicine, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia
| | - Rizwana Shahid
- Department of Neurology, College of Medicine, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia
| | - Fahd Alkhamis
- Department of Neurology, College of Medicine, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia
| | - Majed Alabdali
- Department of Neurology, College of Medicine, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia
| | - Danah Aljaafari
- Department of Neurology, College of Medicine, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia
| | - Saima Nazish
- Department of Neurology, College of Medicine, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia
| | | | - Erum Shariff
- Department of Neurology, College of Medicine, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia
| | - Mohammad Zeeshan
- Department of Medical Education, College of Medicine, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia
| | - Abdulla AlSulaiman
- Department of Neurology, College of Medicine, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia
| | - Abdullah Saleh AlAmri
- Department of Neurology, College of Medicine, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia
| | - Anas Salman Aldehailan
- Department of Neurology, College of Medicine, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia
| | - Hosam Al-Jehani
- Department of Neurosurgery, Critical Care Medicine, and Interventional Radiology, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia
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Owusu-Afriyie B, Gende T, Tapilas M, Zimbare N, Kewande J. Patients’ Perspective on Barriers to Utilization of a Diabetic Retinopathy Screening Service. DIABETOLOGY 2023; 4:393-405. [DOI: 10.3390/diabetology4030033] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/04/2025]
Abstract
This study was conducted to determine the barriers to the utilization of diabetic retinopathy (DR) screening in Papua New Guinea (PNG). A list of patients booked for DR screening at Madang Provincial Hospital Eye Clinic (MPHEC) between January 2017 and December 2021 who had not been screened was retrieved, and the patients were invited to participate in the study. The data were collected using a structured questionnaire, and IBM Statistical Package for Social Sciences version 26 was used for the analysis. p < 0.05 was considered statistically significant. One hundred and twenty-nine patients (37.4%) did not attend DR screening for the period under study. The study response rate was 80.6%. The mean ± SD age of the respondents was 51.5 ± 10.9 years. The majority of the study respondents were female (62.5%), people living in rural settings (53.8%), and farmers (22.1%). Time constraints, poor knowledge about DR, and long waiting periods at the DR screening center were the main barriers to the uptake of DR screening. Compared to respondents in urban communities, those in rural settings were significantly concerned about cost (p < 0.001), travel distance to the MPHEC (p < 0.001), and poor information about DR screening (p = 0.002). More than half of the respondents (63.5%) had discontinued using pharmacotherapy for DM. There is a high rate of nonadherence to diabetes (DM) and DR treatment in PNG. There is a need for public health campaigns about DM and strategic DR screening at the community level in PNG and similar countries.
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Affiliation(s)
- Bismark Owusu-Afriyie
- Faculty of Medicine and Health Sciences, Divine Word University, Madang 511, Papua New Guinea
- The Fred Hollows Foundation NZ, Auckland 1010, New Zealand
| | - Theresa Gende
- Faculty of Medicine and Health Sciences, Divine Word University, Madang 511, Papua New Guinea
- The Fred Hollows Foundation NZ, Auckland 1010, New Zealand
| | - Martin Tapilas
- Faculty of Medicine and Health Sciences, Divine Word University, Madang 511, Papua New Guinea
| | - Nicholas Zimbare
- Faculty of Medicine and Health Sciences, Divine Word University, Madang 511, Papua New Guinea
| | - Jeffrey Kewande
- Faculty of Medicine and Health Sciences, Divine Word University, Madang 511, Papua New Guinea
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Pais R, Cariou B, Noureddin M, Francque S, Schattenberg JM, Abdelmalek MF, Lalazar G, Varma S, Dietrich J, Miller V, Sanyal A, Ratziu V. A proposal from the liver forum for the management of comorbidities in non-alcoholic steatohepatitis therapeutic trials. J Hepatol 2023; 79:829-841. [PMID: 37001695 DOI: 10.1016/j.jhep.2023.03.014] [Citation(s) in RCA: 6] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/15/2022] [Revised: 02/08/2023] [Accepted: 03/13/2023] [Indexed: 06/19/2023]
Abstract
The current document has been developed by the Liver Forum who mandated the NAFLD-Associated Comorbidities Working Group - a multistakeholder group comprised of experts from academic medicine, industry and patient associations - to identify aspects of diverse comorbidities frequently associated with non-alcoholic steatohepatitis (NASH) that can interfere with the conduct of therapeutic trials and, in particular, impact efficacy and safety results. The objective of this paper is to propose guidance for the management of relevant comorbidities in both candidates and actual participants in NASH therapeutic trials. We relied on specific guidelines from scientific societies, when available, but adapted them to the particulars of NASH trials with the aim of addressing multiple interacting requirements such as maintaining patient safety, reaching holistic therapeutic objectives, minimising confounding effects on efficacy and safety of investigational agents and allowing for trial completion. We divided the field of action into: first, analysis and stabilisation of the patient's condition before inclusion in the trial and, second, management of comorbidities during trial conduct. For the former, we discussed the concept of acceptable vs. optimal control of comorbidities, defined metabolic and ponderal stability prior to randomisation and weighed the pros and cons of a run-in period. For the latter, we analysed non-hepatological comorbid conditions for changes or acute events possibly occurring during the trial, including changes in alcohol consumption, in order to detail when specific interventions are necessary and how best to manage concomitant drug intake in line with methodological constraints. These recommendations are intended to act as a guide for clinical trialists and are open to further refinement when additional data become available.
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Affiliation(s)
- Raluca Pais
- Sorbonne Université, Assistance Publique-Hôpitaux de Paris, Hôpital Pitié-Salpêtrière, Institute of Cardiometabolism and Nutrition, France; Centre de Recherche Saint Antoine, INSERM UMRS_938 Paris, France
| | - Bertrand Cariou
- Nantes Université, CHU Nantes, CNRS, INSERM, l'institut du Thorax, F-44000 Nantes, France
| | | | - Sven Francque
- Department of Gastroenterology Hepatology, Antwerp University Hospital, Drie Eikenstraat 655, B-2650 Edegem, Belgium; InflaMed Centre of Excellence, Laboratory for Experimental Medicine and Paediatrics, Translational Sciences in Inflammation and Immunology, Faculty of Medicine and Health Sciences, University of Antwerp, Universiteitsplein 1, B-2610 Wilrijk, Belgium European Reference Network on Hepatological Diseases (ERN RARE-LIVER), Belgium
| | - Jörn M Schattenberg
- Metabolic Liver Research Program, I. Department of Medicine, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany
| | - Manal F Abdelmalek
- Division of Gastroenterology and Hepatology, Duke University, Durham, NC, USA
| | - Gadi Lalazar
- Liver Unit, Digestive Disease Institute, Shaare Zedek Medical Center, Jerusalem, Israel
| | - Sharat Varma
- Novo Nordisk A/S, Vandtårnsvej 108-110, 2860 Søborg Denmark
| | - Julie Dietrich
- GENFIT, Parc Eurasanté 885, Avenue Eugène Avinée, 59120, Loos, France
| | - Veronica Miller
- Forum for Collaborative Research, University of California Berkeley School of Public Health, Washington D.C., USA
| | - Arun Sanyal
- Virginia Commonwealth University School of Medicine, Richmond, Virginia, USA
| | - Vlad Ratziu
- Sorbonne Université, Assistance Publique-Hôpitaux de Paris, Hôpital Pitié-Salpêtrière, Institute of Cardiometabolism and Nutrition, France; INSERM UMRS 1138 CRC, Paris, France.
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Klaric KA, Parai JL, Kepron CA, Walker AE, Milroy CM. Postmortem survey of haemoglobin A1c, non-alcoholic steatohepatitis and liver fibrosis within a general population. J Clin Pathol 2023; 76:606-611. [PMID: 35534202 DOI: 10.1136/jclinpath-2021-207998] [Citation(s) in RCA: 4] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/16/2021] [Accepted: 04/14/2022] [Indexed: 11/04/2022]
Abstract
AIMS Non-alcoholic steatohepatitis (NASH), fatty liver disease and fibrosis are associated with diabetes mellitus and obesity. Previous autopsy series have reported prevalence of fatty liver disease to be 11%-24%. Recent studies, using imaging and serology, suggest a prevalence of 20%-35%, NASH of 5% and advanced fibrosis of 2%-3%. We examined the prevalence of NASH and liver fibrosis in a general autopsy population. METHODS A cross-sectional study of consecutive, adult, medicolegal autopsies over a 1-year period was conducted. Liver sections were scored for fibrosis, inflammation and steatosis using a modified NASH scoring system. Stepwise logistic regression was used to identify associations between NASH or moderate/severe fibrosis and several clinicopathological parameters, including postmortem haemoglobin A1c (HbA1c). RESULTS Of 376 cases, 86 (22.9%) were classified as NASH. Prevalence of diabetes mellitus, body mass index (BMI) and postmortem HbA1c were significantly higher in NASH cases (39.5%, 32.3 kg/m2 and 6.88%) than non-NASH cases (12.1%, 27.0 kg/m2 and 5.73%). Decedents with moderate/severe fibrosis (6.9%) had higher prevalence of diabetes, BMI and HbA1c (50%, 31.4 kg/m2 and 6.7%) compared with those with no/mild fibrosis (16%, 28 kg/m2 and 5.9%). HbA1c ≥7% was found to be an independent predictor of NASH (OR 5.11, 95% CI 2.61 to 9.98) and advanced fibrosis (OR 3.94, 95% CI 1.63 to 9.53). CONCLUSIONS NASH and advanced fibrosis were higher in our general adult autopsy population compared with previously published estimates. This is a large series with histological evaluation showing that HbA1c >7.0% is independently associated with NASH and advanced fibrosis.
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Affiliation(s)
- Kristina-Ana Klaric
- Department of Pathology and Laboratory Medicine, University of Ottawa Faculty of Medicine, Ottawa, Ontario, Canada
| | - Jacqueline Louise Parai
- Department of Pathology and Laboratory Medicine, University of Ottawa Faculty of Medicine, Ottawa, Ontario, Canada
- Pathology and Laboratory Medicine, Ottawa Hospital General Campus, Ottawa, Ontario, Canada
| | - Charis Anthea Kepron
- Department of Pathology and Laboratory Medicine, University of Ottawa Faculty of Medicine, Ottawa, Ontario, Canada
- Pathology and Laboratory Medicine, Ottawa Hospital General Campus, Ottawa, Ontario, Canada
| | - Alfredo Eugene Walker
- Department of Pathology and Laboratory Medicine, University of Ottawa Faculty of Medicine, Ottawa, Ontario, Canada
- Pathology and Laboratory Medicine, Ottawa Hospital General Campus, Ottawa, Ontario, Canada
| | - Christopher Mark Milroy
- Department of Pathology and Laboratory Medicine, University of Ottawa Faculty of Medicine, Ottawa, Ontario, Canada
- Pathology and Laboratory Medicine, Ottawa Hospital General Campus, Ottawa, Ontario, Canada
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Alsharif AA, Wong ICK, Ma T, Lau W, Alhamed M, Alwafi H, Wei L. The association between dementia and the risk of hypoglycaemia events among patients with diabetes mellitus: a propensity-score matched cohort analysis. Front Med (Lausanne) 2023; 10:1177636. [PMID: 37476614 PMCID: PMC10354255 DOI: 10.3389/fmed.2023.1177636] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/01/2023] [Accepted: 06/02/2023] [Indexed: 07/22/2023] Open
Abstract
Background Hypoglycaemia commonly occurs in patients diagnosed with diabetes mellitus (DM) and dementia. The impact of dementia on hypoglycaemic events is controversial. Thus, we evaluated whether dementia increases the risk of hypoglycaemic events in older patients diagnosed with DM. Design A retrospective cohort study. Setting We used the IQVIA Medical Research Data (IMRD-UK) database (formerly known as the THIN database). Participants All patients aged ≥55 years and diagnosed with DM who were prescribed at least two prescriptions of antidiabetic medication between 2000 and 2017. Two groups of patients, dementia and non-dementia group, were propensity-score (PS) matched at 1:2. The risk of hypoglycaemia was assessed through a Cox regression analysis. Main outcome and measures Hypoglycaemic events were determined during the follow-up period by Read codes. Results From the database, 133,664 diabetic patients were identified, with a mean follow-up of 6.11 years. During the study period, 7,762 diabetic patients diagnosed with dementia were matched with 12,944 diabetic patients who had not been diagnosed with dementia. The PS-matched Cox regression analysis showed that patients diagnosed with dementia were at a 2-fold increased risk for hypoglycaemic events compared with those not diagnosed with dementia (hazard ratio [HR], 2.00; 95% CI, 1.63-2.66). A similar result was shown for a multivariable analysis using all patient data (adjusted HR, 2.25; 95% CI, 2.22-2.32). Conclusion Our findings suggest that diabetic patients with a diagnosis of dementia have a statistically significant higher risk of experiencing hypoglycaemia.
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Affiliation(s)
- Alaa A. Alsharif
- Department of Pharmacy Practice, Faculty of Pharmacy, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia
- Research Department of Practice and Policy, University College London School of Pharmacy, London, United Kingdom
| | - Ian C. K. Wong
- Research Department of Practice and Policy, University College London School of Pharmacy, London, United Kingdom
- Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, Centre for Safe Medication Practice and Research, The University of Hong Kong, Hong Kong, China
| | - Tian Ma
- Research Department of Practice and Policy, University College London School of Pharmacy, London, United Kingdom
| | - Wallis Lau
- Research Department of Practice and Policy, University College London School of Pharmacy, London, United Kingdom
- Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, Centre for Safe Medication Practice and Research, The University of Hong Kong, Hong Kong, China
| | - Meshari Alhamed
- Department of Emergency Medicine, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia
- King Abdullah International Medical Research Center, Riyadh, Saudi Arabia
| | - Hassan Alwafi
- Faculty of Medicine, Umm Al Qura University, Mecca, Saudi Arabia
| | - Li Wei
- Research Department of Practice and Policy, University College London School of Pharmacy, London, United Kingdom
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Sahay RK, Giri R, Shembalkar JV, Gupta SK, Mohan B, Kurmi P, Kumar SR, Sawardekar VM, Mishra A, Murthy LS, Arya VV, Sonawane AR, Soni PN, Gofne SK, Karnawat SR, Rajurkar MN, Patel PM, Lakhwani LK, Mehta SC, Joglekar SJ. Fixed-Dose Combination of Dapagliflozin + Sitagliptin + Metformin in Patients with Type 2 Diabetes Poorly Controlled with Metformin: Phase 3, Randomized Comparison with Dual Combinations. Adv Ther 2023; 40:3227-3246. [PMID: 37258803 DOI: 10.1007/s12325-023-02523-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/27/2023] [Accepted: 04/14/2023] [Indexed: 06/02/2023]
Abstract
INTRODUCTION This study compared efficacy and safety of triple drug fixed-dose combination (FDC) of dapagliflozin (DAPA) + sitagliptin (SITA) + metformin (MET) extended release (ER) with SITA + MET sustained release (SR) and DAPA + MET ER in patients with type 2 diabetes poorly controlled with metformin. METHODS This phase 3, randomized, open-label, active-controlled study included adult patients with glycated hemoglobin (HbA1c) ≥ 8% (64 mmol/mol) and ≤ 11% (97 mmol/mol), randomized in 1:1:1 ratio to receive either FDC of DAPA + SITA + MET ER (10 mg + 100 mg + 1000 mg) tablets once daily (n = 137) or co-administration of SITA + MET SR (100 mg + 1000 mg) tablets once daily (n = 139) or FDC of DAPA + MET ER (10 mg + 1000 mg) tablets once daily (n = 139). Primary endpoint was mean change in HbA1c from baseline to week 16. RESULTS Mean baseline HbA1c was approximately 9% (75 mmol/mol) in each treatment group. At week 16, adjusted mean reduction in HbA1c from baseline was significantly greater with DAPA + SITA + MET ER (- 1.73% [- 19.0 mmol/mol]) compared to SITA + MET SR (- 1.28% [- 14.1 mmol/mol]; difference of - 0.46% [- 5.1 mmol/mol], p < 0.001) and DAPA + MET ER (- 1.33% [- 14.6 mmol/mol]; difference - 0.4% [4.4 mmol/mol], p < 0.001). Similarly, at week 12, reduction in HbA1c from baseline was significantly greater with DAPA + SITA + MET ER compared to SITA + MET SR (p = 0.0006) and DAPA + MET ER (p = 0.0276). At week 16, DAPA + SITA + MET ER showed significant reduction in postprandial blood glucose compared to DAPA + MET ER (p = 0.0394) and significant reduction in fasting blood glucose with DAPA + SITA + MET ER compared to SITA + MET SR (p = 0.0226). The proportion of patients achieving HbA1c < 7.0% (53 mmol/mol) at week 16 was significantly higher with DAPA + SITA + MET ER (38.5%) versus SITA + MET SR (12.8%) (p < 0.001) and DAPA + MET ER (21.3%) (p = 0.0023). All study medications were well tolerated. CONCLUSION Triple FDC of DAPA + SITA + MET ER tablets once daily was significantly better in achieving glycemic control versus dual combination once daily in patients with type 2 diabetes poorly controlled with metformin without any significant safety concerns. TRIAL REGISTRATION CTRI/2021/11/038176, registered on 22 November 2021.
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Affiliation(s)
| | | | | | | | - Brij Mohan
- Brij Medical Centre Pvt Ltd., Kanpur, India
| | | | | | | | | | | | | | | | - Pravin N Soni
- PCMC'S PGI Yashwantrao Chavan Memorial Hospital, Pune, India
| | | | - Shital R Karnawat
- Chopda Medicare & Research Centre Pvt. Ltd., Magnum Heart Institute, Nashik, India
| | - Mandodari N Rajurkar
- Sun Pharma Laboratories Limited, India Clinical Research, Sun House, Plot Number 201 B/1, Western Express Highway, Goregaon (East), Mumbai, 400063, India.
| | - Piyush M Patel
- Sun Pharma Laboratories Limited, India Clinical Research, Sun House, Plot Number 201 B/1, Western Express Highway, Goregaon (East), Mumbai, 400063, India
| | - Lalit K Lakhwani
- Sun Pharma Laboratories Limited, India Clinical Research, Sun House, Plot Number 201 B/1, Western Express Highway, Goregaon (East), Mumbai, 400063, India
| | - Suyog C Mehta
- Sun Pharma Laboratories Limited, India Clinical Research, Sun House, Plot Number 201 B/1, Western Express Highway, Goregaon (East), Mumbai, 400063, India
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Swaray SM, Tetteh J, Djonor SK, Ekem-Ferguson G, Clottey RY, Yacoba A, Yawson AE. Changes in trends and patterns of glycaemic control at Ghana's National Diabetes Management and Research Centre during the era of the COVID-19 pandemic. PLOS GLOBAL PUBLIC HEALTH 2023; 3:e0002024. [PMID: 37315063 DOI: 10.1371/journal.pgph.0002024] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Received: 08/29/2022] [Accepted: 05/12/2023] [Indexed: 06/16/2023]
Abstract
BACKGROUND Maintaining optimal glycaemic control (GC) delays the onset and progression of diabetes-related complications, especially microvascular complications. We aimed to establish the trend and pattern of GC, and its associated factors in persons living with diabetes (PLWD), and to examine the influence of COVID-19 on GC. METHODS A retrospective study involving secondary data from 2,593 patients' physical records from the National Diabetes Management and Research Centre (NDMRC) in Accra, extracted from 2015-2021. Growth rate of GC was assessed, and ordinal logistic and Poisson models weighted with Mahalanobis distance matching within propensity caliper were adopted to assess the impact of COVID-19 pandemic on GC. Stata 16.1 was utilized and the significant value set as p≤0.05. RESULTS GC pattern indicated a steady deterioration ranging from 38.6% (95%CI = 34.5-42.9) in 2015 to 69.2% (95%CI = 63.5-74.4) in 2021. The overall growth from 2015-2021 was 8.7%. Being a woman and increasing diastolic pressure significantly increase the likelihood of poor glycaemic control (PGC) by 22% and 25%, respectively compared with their respective counterparts [aOR(95%CI = 1.01-1.46 and 1.25(1.10-1.41), respectively]; whilst lower age increased the risk of PGC throughout the years. We found that risk of PGC during the era of COVID-19 was approximately 1.57(95%CI = 1.08-2.30) times significant, whilst the adjusted prevalence ratio (aPR) of PGC during the era of COVID-19 was approximately 64% significantly higher than the era without COVID-19 (aPR = 1.64, 95%CI = 1.10-2.43). CONCLUSION GC worsened from 2015-2021, especially during the COVID era. Younger age, uncontrolled blood pressure and/or being a woman were associated with PGC. The NDMRC and other centres that provide specialist healthcare in resource-limited settings, must determine the factors that militate against optimal service delivery in the era of the COVID-19 pandemic, and implement measures that would improve resilience in provision of essential care in the face of shocks.
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Affiliation(s)
| | - John Tetteh
- Department of Community Health, University of Ghana Medical School, College of Health Sciences, University of Ghana, Accra, Ghana
| | | | - George Ekem-Ferguson
- National Cardiothoracic Centre, Korle Bu Teaching Hospital, Accra, Ghana
- Department of Psychiatry, Korle Bu Teaching Hospital, Accra, Ghana
| | - Ruth Yawa Clottey
- National Diabetes Management and Research Centre, Korle-Bu Teaching Hospital, Accra, Ghana
| | - Atiase Yacoba
- National Diabetes Management and Research Centre, Korle-Bu Teaching Hospital, Accra, Ghana
- Department of Medicine & Therapeutics, University of Ghana Medical School, Accra, Ghana
| | - Alfred Edwin Yawson
- Department of Community Health, University of Ghana Medical School, College of Health Sciences, University of Ghana, Accra, Ghana
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Adane T, Melku M, Worku YB, Fasil A, Aynalem M, Kelem A, Getawa S. The Association between Neutrophil-to-Lymphocyte Ratio and Glycemic Control in Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis. J Diabetes Res 2023; 2023:3117396. [PMID: 37305430 PMCID: PMC10257553 DOI: 10.1155/2023/3117396] [Citation(s) in RCA: 28] [Impact Index Per Article: 14.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/29/2022] [Revised: 04/18/2023] [Accepted: 05/26/2023] [Indexed: 06/13/2023] Open
Abstract
Background Glycated hemoglobin (HbA1c) is a commonly used clinical marker to monitor the control of type 2 diabetes mellitus patients (T2DM). However, it is unable to identify the ongoing inflammatory changes in the body. These factors could be easily identified and monitored by the neutrophil-to-lymphocyte ratio (NLR). Therefore, this study is aimed at investigating the relationship between NLR and glycemic control in T2DM. Method A comprehensive search of eligible studies was performed in various databases published until July 2021. A random effect model was used to estimate the standardized mean difference (SMD). A metaregression, subgroup, and sensitivity analysis were conducted to search for potential sources of heterogeneity. Result A total of 13 studies were included in this study. Accordingly, the SMD of the NLR values between the poor and good glycemic control groups was 0.79 (95% CI, 0.46-1.12). Our study also showed that high NLR was significantly associated with poor glycemic control in T2DM patients (OR = 1.50, 95% CI: 1.30-1.93). Conclusion The results of this study suggest an association between high NLR values and an elevated HbA1C in T2DM patients. Therefore, NLR should be considered a marker of glycemic control in addition to HbA1c in T2DM patients.
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Affiliation(s)
- Tiruneh Adane
- Department of Hematology and Immunohematology, School of Biomedical and Laboratory Sciences, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia
| | - Mulugeta Melku
- Department of Hematology and Immunohematology, School of Biomedical and Laboratory Sciences, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia
| | - Yilkal Belete Worku
- Department of Internal Medicine, School of Medicine, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia
| | - Alebachew Fasil
- Department of Clinical Chemistry, School of Biomedical and Laboratory Sciences, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia
| | - Melak Aynalem
- Department of Hematology and Immunohematology, School of Biomedical and Laboratory Sciences, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia
| | - Amanuel Kelem
- Department of Medical Laboratory Sciences, Asrat Woldeyes Health Science Campus, Debre Berhan University, Debre Berhan, Ethiopia
| | - Solomon Getawa
- Department of Hematology and Immunohematology, School of Biomedical and Laboratory Sciences, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia
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Haghdoost A, Bakhshandeh S, Tohidi S, Ghorbani Z, Namdari M. Improvement of oral health knowledge and behavior of diabetic patients: an interventional study using the social media. BMC Oral Health 2023; 23:359. [PMID: 37270487 DOI: 10.1186/s12903-023-03007-w] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/17/2022] [Accepted: 05/03/2023] [Indexed: 06/05/2023] Open
Abstract
BACKGROUND Diabetic patients are not often aware of relationship between diabetes mellitus (DM) and periodontal diseases, and the researchers recommend further knowledge enhancement of diabetic patients in this regard. This study aimed to enhance oral health knowledge of diabetic adults via an educational intervention. METHODS In this interventional study, three private offices of endocrinologists specialized in treatment of DM were selected for the recruitment of participants. In total, 120 diabetic adults (40 from each office) took part in an educational intervention in three groups (patients from each office made up one group): (I) physician-aid, (II) researcher-aid, and (III) social media. In group (I), participants received educational materials (brochure and CD) from their endocrinologist, in group (II) participants received educational materials from researcher. Group (III) joining an educational group in WhatsApp for 3 months. A self-reported standard questionnaire was filled out by the patients before, and after the intervention to assess oral health knowledge. Data were analyzed by SPSS version 21 using independent t-test, Mann-Whitney test, Chi-square test, and ANCOVA. RESULTS The mean oral health knowledge score increased in all three groups after the educational interventions (P < 0.001); the highest increase occurred in the social media group. Toothbrushing twice daily or more had the greatest improvement in the physician-aid group compared with the other two groups (P < 0.001). The greatest improvement in dental flossing once daily or more occurred in the social media group (P = 0.01). The mean level of the hemoglobin A1c (HbA1c) decreased in all three groups, but not significantly (P = 0.83). CONCLUSION The results showed that educational interventions enhance oral health knowledge, and improve the behavior of diabetic adults. The education via the social media can be an efficient method for knowledge enhancement of diabetic patients.
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Affiliation(s)
- Atousa Haghdoost
- Dental Research Center, Research Institute of Dental Sciences, School of Dentistry, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | - Soheila Bakhshandeh
- Department of Community Oral Health, School of Dentistry, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
| | - Sajjad Tohidi
- Department of Endodontics, School of Dentistry, Qazvin University of Medical Science, Qazvin, Iran
| | - Zahra Ghorbani
- Department of Community Oral Health, School of Dentistry, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | - Mahshid Namdari
- Department of Community Oral Health, School of Dentistry, Shahid Beheshti University of Medical Sciences, Tehran, Iran
- Department of Biostatistics, School of Allied Medical Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran
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Raets L, Van Doninck L, Van Crombrugge P, Moyson C, Verhaeghe J, Vandeginste S, Verlaenen H, Vercammen C, Maes T, Dufraimont E, Roggen N, De Block C, Jacquemyn Y, Mekahli F, De Clippel K, Van Den Bruel A, Loccufier A, Laenen A, Devlieger R, Mathieu C, Benhalima K. Normal glucose tolerant women with low glycemia during the oral glucose tolerance test have a higher risk to deliver a low birth weight infant. Front Endocrinol (Lausanne) 2023; 14:1186339. [PMID: 37334297 PMCID: PMC10272607 DOI: 10.3389/fendo.2023.1186339] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/14/2023] [Accepted: 05/22/2023] [Indexed: 06/20/2023] Open
Abstract
Background Data are limited on pregnancy outcomes of normal glucose tolerant (NGT) women with a low glycemic value measured during the 75g oral glucose tolerance test (OGTT). Our aim was to evaluate maternal characteristics and pregnancy outcomes of NGT women with low glycemia measured at fasting, 1-hour or 2-hour OGTT. Methods The Belgian Diabetes in Pregnancy-N study was a multicentric prospective cohort study with 1841 pregnant women receiving an OGTT to screen for gestational diabetes (GDM). We compared the characteristics and pregnancy outcomes in NGT women according to different groups [(<3.9mmol/L), (3.9-4.2mmol/L), (4.25-4.4mmol/L) and (>4.4mmol/L)] of lowest glycemia measured during the OGTT. Pregnancy outcomes were adjusted for confounding factors such as body mass index (BMI) and gestational weight gain. Results Of all NGT women, 10.7% (172) had low glycemia (<3.9 mmol/L) during the OGTT. Women in the lowest glycemic group (<3.9mmol/L) during the OGTT had compared to women in highest glycemic group (>4.4mmol/L, 29.9%, n=482), a better metabolic profile with a lower BMI, less insulin resistance and better beta-cell function. However, women in the lowest glycemic group had more often inadequate gestational weight gain [51.1% (67) vs. 29.5% (123); p<0.001]. Compared to the highest glycemia group, women in the lowest group had more often a birth weight <2.5Kg [adjusted OR 3.41, 95% CI (1.17-9.92); p=0.025]. Conclusion Women with a glycemic value <3.9 mmol/L during the OGTT have a higher risk for a neonate with birth weight < 2.5Kg, which remained significant after adjustment for BMI and gestational weight gain.
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Affiliation(s)
- Lore Raets
- Department of Endocrinology, University Hospital Gasthuisberg, KU Leuven, Leuven, Belgium
| | | | - Paul Van Crombrugge
- Department of Endocrinology, Onze-Lieve-Vrouwziekenhuis (OLV) Ziekenhuis Aalst-Asse-Ninove, Aalst, Belgium
| | - Carolien Moyson
- Department of Endocrinology, University Hospital Gasthuisberg, KU Leuven, Leuven, Belgium
| | - Johan Verhaeghe
- Department of Obstetrics & Gynecology, Universitair Ziekenhuis (UZ) Gasthuisberg, KU Leuven, Leuven, Belgium
| | - Sofie Vandeginste
- Department of Obstetrics & Gynecology, Onze-Lieve-Vrouwziekenhuis (OLV) Ziekenhuis Aalst-Asse-Ninove, Aalst, Belgium
| | - Hilde Verlaenen
- Department of Obstetrics & Gynecology, Onze-Lieve-Vrouwziekenhuis (OLV) Ziekenhuis Aalst-Asse-Ninove, Aalst, Belgium
| | - Chris Vercammen
- Department of Endocrinology, Imelda Ziekenhuis, Bonheiden, Belgium
| | - Toon Maes
- Department of Endocrinology, Imelda Ziekenhuis, Bonheiden, Belgium
| | - Els Dufraimont
- Department of Obstetrics & Gynecology, Imelda Ziekenhuis, Bonheiden, Belgium
| | - Nele Roggen
- Department of Obstetrics & Gynecology, Imelda Ziekenhuis, Bonheiden, Belgium
| | - Christophe De Block
- Department of Endocrinology-Diabetology-Metabolism, Antwerp University Hospital, Edegem, Belgium
| | - Yves Jacquemyn
- Department of Obstetrics & Gynecology, Antwerp University Hospital, Edegem, Belgium
- Antwerp Surgical Training, Anatomy and Research Centre (ASTARC) and Global Health Institute (GHI), Antwerp University University of Antwerp (UA), Antwerp, Belgium
| | - Farah Mekahli
- Department of Endocrinology, Kliniek St-Jan Brussel, Brussel, Belgium
| | - Katrien De Clippel
- Department of Obstetrics & Gynecology, Kliniek St-Jan Brussel, Brussel, Belgium
| | - Annick Van Den Bruel
- Department of Endocrinology, Algemeen Ziekenhuis (AZ) St. Jan Brugge, Brugge, Belgium
| | - Anne Loccufier
- Department of Obstetrics & Gynecology, Algemeen Ziekenhuis (AZ) St. Jan Brugge, Brugge, Belgium
| | - Annouschka Laenen
- Center of Biostatics and Statistical bioinformatics, KU Leuven, Leuven, Belgium
| | - Roland Devlieger
- Department of Obstetrics & Gynecology, Universitair Ziekenhuis (UZ) Gasthuisberg, KU Leuven, Leuven, Belgium
| | - Chantal Mathieu
- Department of Endocrinology, University Hospital Gasthuisberg, KU Leuven, Leuven, Belgium
| | - Katrien Benhalima
- Department of Endocrinology, University Hospital Gasthuisberg, KU Leuven, Leuven, Belgium
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Bolat S, Ertürk Zararsız G, Doğan K, Kochan N, Yerlitaş SI, Cephe A, Zararsız G, Cicero AFG. Concordance of LDL-C Estimating Equations with Direct Enzymatic Measurement in Diabetic and Prediabetic Subjects. J Clin Med 2023; 12:jcm12103570. [PMID: 37240676 DOI: 10.3390/jcm12103570] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/01/2023] [Revised: 05/13/2023] [Accepted: 05/16/2023] [Indexed: 05/28/2023] Open
Abstract
Low-density lipoprotein cholesterol (LDL-C) is a well-established biomarker in the management of dyslipidemia. Therefore, we aimed to evaluate the concordance of LDL-C-estimating equations with direct enzymatic measurement in diabetic and prediabetic populations. The data of 31,031 subjects included in the study were divided into prediabetic, diabetic, and control groups according to HbA1c values. LDL-C was measured by direct homogenous enzymatic assay and calculated by Martin-Hopkins, Martin-Hopkins extended, Friedewald, and Sampson equations. The concordance statistics between the direct measurements and estimations obtained by the equations were evaluated. All equations evaluated in the study had lower concordance with direct enzymatic measurement in diabetic and prediabetic groups compared to the non-diabetic group. Even so, the Martin-Hopkins extended approach demonstrated the highest concordance statistic in diabetic and prediabetic patients. Further, Martin-Hopkins extended was found to have the highest correlation with direct measurement compared with other equations. Over the 190 mg/dL LDL-C concentrations, the equation with the highest concordance was again Martin-Hopkins extended. In most scenarios, the Martin-Hopkins extended performed best in prediabetic and diabetic groups. Additionally, direct assay methods can be used at low values of the non-HDL-C/TG ratio (<2.4), as the performance of the equations in LDL-C estimation decreases as non-HDL-C/TG decreases.
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Affiliation(s)
- Serkan Bolat
- Department of Biochemistry, Sivas Cumhuriyet University School of Medicine, Sivas 58140, Turkey
| | - Gözde Ertürk Zararsız
- Department of Biostatistics, Erciyes University School of Medicine, Kayseri 38039, Turkey
- Drug Application and Research Center (ERFARMA), Erciyes University, Kayseri 38280, Turkey
| | - Kübra Doğan
- Department of Biochemistry, Sivas Numune Hospital, Sivas 58380, Turkey
| | - Necla Kochan
- İzmir Biomedicine and Genome Center (IBG), İzmir 35340, Turkey
| | - Serra I Yerlitaş
- Department of Biostatistics, Erciyes University School of Medicine, Kayseri 38039, Turkey
- Drug Application and Research Center (ERFARMA), Erciyes University, Kayseri 38280, Turkey
| | - Ahu Cephe
- Institutional Data Management and Analytics Unit, Erciyes University Rectorate, Kayseri 38280, Turkey
| | - Gökmen Zararsız
- Department of Biostatistics, Erciyes University School of Medicine, Kayseri 38039, Turkey
- Drug Application and Research Center (ERFARMA), Erciyes University, Kayseri 38280, Turkey
| | - Arrigo F G Cicero
- Medical and Surgical Sciences Department, Alma Mater Studiorum University of Bologna, 40126 Bologna, Italy
- Cardiovascular Medicine Unit, IRCCS AOU S. Orsola di Bologna, 40138 Bologna, Italy
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Roberts G, Krinsley JS, Preiser JC, Quinn S, Rule PR, Brownlee M, Umpierrez GE, Hirsch IB. Malglycemia in the critical care setting. Part I: Defining hyperglycemia in the critical care setting using the glycemic ratio. J Crit Care 2023; 77:154327. [PMID: 37178493 DOI: 10.1016/j.jcrc.2023.154327] [Citation(s) in RCA: 5] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/22/2023] [Revised: 04/29/2023] [Accepted: 05/05/2023] [Indexed: 05/15/2023]
Abstract
INTRODUCTION Stress-induced hyperglycemia (SIH) is conventionally represented by Blood Glucose (BG) although recent evidence indicates the Glycemic Ratio (GR, quotient of mean BG and estimated preadmission BG) is a superior prognostic marker. We assessed the association between in-hospital mortality and SIH, using BG and GR in an adult medical-surgical ICU. METHODS We included patients with hemoglobin A1c (HbA1c) and minimum four BGs in a retrospective cohort investigation (n = 4790). RESULTS A critical SIH threshold of GR 1.1 was identified. Mortality increased with increasing exposure to GR ≥ 1.1 (r2 = 0.94, p = 0.0007). Duration of exposure to BG ≥ 180 mg/dL demonstrated a less robust association with mortality (r2 = 0.75, p = 0.059). In risk-adjusted analyses, hours GR ≥ 1.1 (OR 1.0014, 95%CI (1.0003-1.0026), p = 0.0161) and hours BG ≥ 180 mg/dL (OR 1.0080, 95%CI (1.0034-1.0126), p = 0.0006) were associated with mortality. In the cohort with no exposure to hypoglycemia however, only hours GR ≥ 1.1 was associated with mortality (OR 1.0027, 95%CI (1.0012-1.0043), p = 0.0007), not BG ≥ 180 mg/dL (OR 1.0031, 95%CI (0.9949-1.0114), p = 0.50) and this relationship remained intact for those who never experienced BG outside the 70-180 mg/dL range (n = 2494). CONCLUSIONS Clinically significant SIH commenced above GR 1.1. Mortality was associated with hours of exposure to GR ≥ 1.1 which was a superior marker of SIH compared to BG.
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Affiliation(s)
- Greg Roberts
- SA Pharmacy, Flinders Medical Centre, Bedford Park, SA 5042, Australia; College of Medicine and Public Health, Flinders University, Bedford Park, SA 5042, Australia.
| | - James S Krinsley
- Division of Critical Care, Department of Medicine, Stamford Hospital, and the Columbia Vagelos College of Physicians and Surgeons, Stamford, CT, United States of America
| | | | - Stephen Quinn
- Department of Health Science and Biostatistics, Swinburne University of Technology, Hawthorn, Victoria, Australia.
| | - Peter R Rule
- PRI, Los Altos Hills, CA, United States of America
| | - Michael Brownlee
- Diabetes Research Emeritus, Biomedical Sciences Emeritus, Einstein Diabetes Research Center, Department of Medicine and Pathology Emeritus, Albert Einstein College of Medicine, Bronx, NY, United States of America.
| | - Guillermo E Umpierrez
- Division of Metabolism, Endocrinology and Nutrition, University of Washington Medicine Diabetes Institute, Seattle, WA, United States of America.
| | - Irl B Hirsch
- Department of Medicine, Division of Endocrinology, Emory University School of Medicine, Atlanta, GA, United States of America.
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Cranston I, Jamdade V, Liao B, Newson RS. Clinical, Economic, and Patient-Reported Benefits of Connected Insulin Pen Systems: A Systematic Literature Review. Adv Ther 2023; 40:2015-2037. [PMID: 36928495 PMCID: PMC10130105 DOI: 10.1007/s12325-023-02478-1] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/08/2022] [Accepted: 02/21/2023] [Indexed: 03/18/2023]
Abstract
INTRODUCTION The objective of this systematic literature review was to evaluate the available literature concerning the clinical, economic, and patient-reported benefits of insulin pen platforms, including connected insulin pens/caps/sleeves and insulin platforms, as well as mobile apps capable of receiving near real-time insulin dosing information. METHODS Medline and Embase databases and the Cochrane Library were searched for published literature between January 2015 and May 2021, and manual searches for conference abstracts from 2018 to May 2021 were performed. These searches were supplemented by internet searches for relevant literature and clinical trials. Study selection involved the population, intervention, comparator, outcomes, time frame, and study design outline. Included studies investigated connected insulin systems or connected caps/sleeves enabling pens to be connected, or apps able to connect to these systems, in individuals of all ages with type 1 or type 2 diabetes mellitus. RESULTS Searches identified a total of 26 publications (mostly observational studies and conference abstracts) for inclusion, representing ten unique, predominantly small studies. Evidence in this field is still in its early stages, and only two randomized controlled trials met our inclusion criteria. Available results showed that connected insulin pens and their systems potentially helped reduce suboptimal insulin use and may therefore improve glycemic control. Satisfaction of people with diabetes with the technologies used was high, and economic benefits were noted. Features of effective connected insulin pen devices include simplicity of use and data upload/sharing, useful "point-of-care" alerts, and simple and understandable data presentation to facilitate more effective consultations. CONCLUSIONS Connected insulin pen systems could be increasingly considered as part of routine clinical care for insulin-treated persons with diabetes who must manage the complexity of their daily insulin routine. Future research focusing on the way data obtained from these devices can be most effectively used alongside other information is urgently needed.
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Affiliation(s)
- Iain Cranston
- Academic Department of Endocrinology and Diabetes, Portsmouth Hospitals University NHS Trust, Portsmouth, UK
| | | | | | - Rachel S Newson
- Eli Lilly and Company, 60 Margaret Street, Sydney, NSW, 2000, Australia.
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Alenazi F, Peddle M, Bressington D, Mahzari M, Gray R. Adherence therapy for adults with type 2 diabetes: a feasibility study of a randomized controlled trial. Pilot Feasibility Stud 2023; 9:71. [PMID: 37106431 PMCID: PMC10134646 DOI: 10.1186/s40814-023-01294-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/26/2022] [Accepted: 04/10/2023] [Indexed: 04/29/2023] Open
Abstract
BACKGROUND Adherence Therapy is a candidate intervention to promote consistent medication taking in people with type 2 diabetes. The aim of this study was to establish the feasibility of conducting a randomized controlled trial of adherence therapy in people with type 2 diabetes who were non-adherent with medication. METHODS The design is an open-label, single-center, randomized controlled feasibility trial. Participants were randomly allocated to receive either eight sessions of telephone-delivered adherence therapy or treatment as usual. Recruitment occurred during the COVID-19 pandemic. Outcome measures-adherence, beliefs about medication, and average blood glucose (sugar) levels (HbA1c)-were administered at baseline and after 8 weeks (TAU group) or at the completion of the treatment (AT group). Feasibility outcomes included the number of people approached to participate in the trial and the numbers that consented, completed study measures, finished treatment with adherence therapy, and dropped out of the trial. Fieldwork for this trial was conducted in the National Guard Hospital, a tertiary care provider, in the Kingdom of Saudi Arabia. RESULTS Seventy-eight people were screened, of which 47 met eligibility criteria and were invited to take part in the trial. Thirty-four people were excluded for various reasons. The remaining thirteen who consented to participate were enrolled in the trial and were randomized (AT, n = 7) (TAU, n = 6). Five (71%) of the seven participants in the adherence therapy arm completed treatment. Baseline measures were completed by all participants. Week 8 (post-treatment) measures were completed by eight (62%) participants. Dropout may have been linked to a poor understanding of what was involved in taking part in the trial. CONCLUSIONS It may be feasible to conduct a full RCT of adherence therapy, but careful consideration should be given to developing effective recruitment strategies, consent procedures, rigorous field testing, and clear support materials. TRIAL REGISTRATION The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12619000827134, on the 7th of June 2019.
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Affiliation(s)
- Fatimah Alenazi
- School of Nursing and Midwifery, La Trobe University, Melbourne, Victoria, 3086, Australia.
- Department of Public Health, College of Public Health and Health Informatics, Qassim University, AlBukayriyah, Kingdom of Saudi Arabia.
| | - Monica Peddle
- School of Nursing and Midwifery, Deakin University, Melbourne, Australia
| | - Daniel Bressington
- Faculty of Nursing, Chiang Mai University, 110/406 Inthawaroros Road, Sri Phum District, Chiang Mai, 50200, Thailand
- Faculty of Health, Charles Darwin University, Ellengowan Drive, Darwin, Northern Territory, 0810, Australia
| | - Moeber Mahzari
- College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Kingdom of Saudi Arabia
- Department of Medicine, Division of Endocrinology, Ministry of National Guard, Health Affairs, Riyadh, Kingdom of Saudi Arabia
- King Abdullah International Medical Research Center, Riyadh, Kingdom of Saudi Arabia
| | - Richard Gray
- School of Nursing and Midwifery, La Trobe University, Melbourne, Victoria, 3086, Australia
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