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Msane S, Khathi A, Sosibo A. Therapeutic Potential of Various Intermittent Fasting Regimens in Alleviating Type 2 Diabetes Mellitus and Prediabetes: A Narrative Review. Nutrients 2024; 16:2692. [PMID: 39203828 PMCID: PMC11357349 DOI: 10.3390/nu16162692] [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: 06/14/2024] [Revised: 07/22/2024] [Accepted: 08/12/2024] [Indexed: 09/03/2024] Open
Abstract
Intermittent fasting has drawn significant interest in the clinical research community due to its potential to address metabolic complications such as obesity and type 2 diabetes mellitus. Various intermittent fasting regimens include alternate-day fasting (24 h of fasting followed by 24 h of eating), time-restricted fasting (fasting for 14 h and eating within a 10 h window), and the 5:2 diet (fasting for two days and eating normally for the other five days). Intermittent fasting is associated with a reduced risk of type 2 diabetes mellitus-related complications and can slow their progression. The increasing global prevalence of type 2 diabetes mellitus highlights the importance of early management. Since prediabetes is a precursor to type 2 diabetes mellitus, understanding its progression is essential. However, the long-term effects of intermittent fasting on prediabetes are not yet well understood. Therefore, this review aims to comprehensively compile existing knowledge on the therapeutic effects of intermittent fasting in managing type 2 diabetes mellitus and prediabetes.
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Affiliation(s)
| | - Andile Khathi
- Department of Human Physiology, School of Laboratory Medicine and Medical Sciences, College of Health Sciences, University of KwaZulu-Natal, Durban 4041, South Africa;
| | - Aubrey Sosibo
- Department of Human Physiology, School of Laboratory Medicine and Medical Sciences, College of Health Sciences, University of KwaZulu-Natal, Durban 4041, South Africa;
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Emad-Eldin M, Balata GF, Elshorbagy EA, Hamed MS, Attia MS. Insulin therapy in type 2 diabetes: Insights into clinical efficacy, patient-reported outcomes, and adherence challenges. World J Diabetes 2024; 15:828-852. [PMID: 38766443 PMCID: PMC11099362 DOI: 10.4239/wjd.v15.i5.828] [Citation(s) in RCA: 2] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/25/2023] [Revised: 02/01/2024] [Accepted: 03/20/2024] [Indexed: 05/10/2024] Open
Abstract
Insulin therapy plays a crucial role in the management of type 2 diabetes as the disease progresses. Over the past century, insulin formulations have undergone significant modifications and bioengineering, resulting in a diverse range of available insulin products. These products show distinct pharmacokinetic and pharmacodynamic profiles. Consequently, various insulin regimens have em-erged for the management of type 2 diabetes, including premixed formulations and combinations of basal and bolus insulins. The utilization of different insulin regimens yields disparate clinical outcomes, adverse events, and, notably, patient-reported outcomes (PROs). PROs provide valuable insights from the patient's perspective, serving as a valuable mine of information for enhancing healthcare and informing clinical decisions. Adherence to insulin therapy, a critical patient-reported outcome, significantly affects clinical outcomes and is influenced by multiple factors. This review provides insights into the clinical effectiveness of various insulin preparations, PROs, and factors impacting insulin therapy adherence, with the aim of enhancing healthcare practices and informing clinical decisions for individuals with type 2 diabetes.
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Affiliation(s)
- Mahmoud Emad-Eldin
- Department of Pharmacy Practice, Faculty of Pharmacy, Zagazig University, Zagazig HFQM+872, Al-Sharqia Governorate, Egypt
| | - Gehan F Balata
- Department of Pharmacy Practice, Faculty of Pharmacy, Heliopolis University, Cairo 44519, Egypt
- Department of Pharmaceutics, Faculty of Pharmacy, Zagazig University, Zagazig 44519, Al-Sharqia Governorate, Egypt
| | - Eman A Elshorbagy
- Department of Internal Medicine, Faculty of Medicine, Zagazig University, Zagazig 44519, Al-Sharqia Governorate, Egypt
| | - Mona S Hamed
- Department of Community at Faculty of Medicine, Zagazig University, Zagazig 44519, Al-Sharqia Governorate, Egypt
| | - Mohamed S Attia
- Department of Pharmaceutics, Faculty of Pharmacy, Zagazig University, Zagazig 44519, Al-Sharqia Governorate, Egypt
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Zhang P, Bao Y, Chen M, Zhang H, Zhu D, Ji L, Li X, Ji J, Zhao F, Fisher EB, Zhao Y, Duolikun N, Wang D, Jia W. Changes of health-related quality of life after initiating basal insulin treatment among people with type 2 diabetes. Medicine (Baltimore) 2023; 102:e34718. [PMID: 37653806 PMCID: PMC10470713 DOI: 10.1097/md.0000000000034718] [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: 09/05/2022] [Revised: 07/20/2023] [Accepted: 07/21/2023] [Indexed: 09/02/2023] Open
Abstract
To assess the association between insulin regimens and health-related quality of life (HRQoL) after the introduction of basal insulin (BI) among people with type 2 diabetes in real-world clinical settings. 16,339 registered people with diabetes who had inadequate glycaemic control by oral agents initiated BI (either single BI or Basal-bolus) and completed a 6-month follow-up from 209 hospitals were included in the analyses. At the end of the follow-up, the switches of insulin regimens, change of HRQoL (EQ-5D-3L) and their associations were assessed. Initial insulin regimens of single BI and of basal-bolus (BI included Glargine, Detemir, and Neutral Protamine Hagedorn) accounted for 75.6% and 24.4%, respectively. At 6 months, regimens used were BI alone (65.2%), basal-bolus (10.4%), and premixed (6.4%), whereas 17.9% stopped all insulin therapy. The visual analogue scale score increased by 5.46 (P < .001), and the index value increased slightly by 0.02 (P < .001). Univariate analysis showed that people with diabetes taking basal-bolus regimen had the greatest improvement on HRQoL in all dimensions, especially in the reduction of the percentage of Pain/Discomfort (by 10.03%) and Anxiety/Depression (by 11.21%). In multivariable analysis, single BI or premixed insulin at 6 months was associated with more improvement of visual analogue scale score compared with stopping all insulin. Improved HRQoL was observed after initiating BI in people with type 2 diabetes . If the same achievement on HbA1c control can be guaranteed, single BI is preferred to other regimens from the viewpoint of HRQoL. Basal-bolus has the most significant potential to increase HRQoL, however, the people with diabetes characteristics differ from those initiating BI alone. Further longitudinal cohort study with a longer study period might be necessary to evaluate the certain effect.
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Affiliation(s)
- Puhong Zhang
- The George Institute for Global Health, Beijing, China
- The George Institute for Global Health, Faculty of Medicine and Health, University of New South Wales, Sydney, NSW
| | - Yuqian Bao
- Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People’s Hospital, Shanghai, China
| | - Minyuan Chen
- The George Institute for Global Health, Beijing, China
| | - Heng Zhang
- The George Institute for Global Health, Beijing, China
| | - Dongshan Zhu
- The George Institute for Global Health, Beijing, China
| | - Linong Ji
- The George Institute for Global Health, Beijing, China
- Department of Endocrinology and Metabolism, Peking University People’s Hospital, Beijing, China
| | - Xian Li
- The George Institute for Global Health, Beijing, China
| | - Jiachao Ji
- The George Institute for Global Health, Beijing, China
| | - Fang Zhao
- The George Institute for Global Health, Beijing, China
| | - Edwin B. Fisher
- Peers for Progress and Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC
| | - Yang Zhao
- The George Institute for Global Health, Beijing, China
- WHO Collaborating Centre on Implementation Research for Prevention and Control of Noncommunicable Diseases, Melbourne, VIC
| | | | - Du Wang
- The George Institute for Global Health, Beijing, China
| | - Weiping Jia
- Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People’s Hospital, Shanghai, China
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Sendekie AK, Netere AK, Belachew EA. Hypoglycemic events and glycemic control effects between NPH and premixed insulin in patients with type 2 diabetes mellitus: A real-world experience at a comprehensive specialized hospital in Ethiopia. PLoS One 2022; 17:e0275032. [PMID: 36149907 PMCID: PMC9506660 DOI: 10.1371/journal.pone.0275032] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/27/2022] [Accepted: 09/09/2022] [Indexed: 11/18/2022] Open
Abstract
BACKGROUND Though initiation of insulin results in a significant change in glycemic levels, treating patients without significant hypoglycemic events remains difficult in diabetes patients initiated with different insulin-based regimens. This study assessed the association of hypoglycemic incidence and glycemic control between NPH and premixed insulin regimens in patients with type 2 diabetes mellitus (T2DM). METHODS This was a retrospective observational study in patients with T2DM who were treated with insulin-based therapy from 2015 to 2020 at the University of Gondar Comprehensive Specialized hospital. Average fasting blood glucose (FBG) between NPH and premixed insulin regimens was compared using an independent t-test. The Association of NPH and premixed insulin regimens with hypoglycemic incidences and glycemic control was examined by a logistic regression model. P < 0.05 was statistically significant. RESULTS From 405 participants, more than half (55.3%) were males with a mean age of 59.2(±9.1) years. Baseline mean HbA1C and FBG levels were 12.73(±1.1) % and 347.7(±48.5) mg/dl, respectively. Within a one-year follow-up period of insulin initiation, the rate of hypoglycemia was 13.1%. The incidence of hypoglycemia was significantly higher in patients initiated with premixed insulin compared with NPH insulin regimens (P < 0.001). After one year of insulin initiation, HbA1C decreased from 12.7 to 7.6 and from 12.8 to 7.3% and FBG levels decreased from 347.5 to 160.7 and from 348.2 to 147.3 mg/dl following initiation of NPH and premixed insulin, respectively. Patients treated with premixed-based insulin were found more likely to achieve target FBG compared with patients treated with NPH insulin regimens after one year of initiation (P = 0.02). CONCLUSION Premixed insulin-based regimen has found to have a higher hypoglycemic incidence, but a better level of glycemic control compared to NPH insulin-based therapy. Therefore, patients initiated with premixed insulin need to be highly vigilant and motivated to recognize the symptoms of hypoglycemia.
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Affiliation(s)
- Ashenafi Kibret Sendekie
- Department of Clinical Pharmacy, School of Pharmacy, College of Medicine and Health Science, University of Gondar, Gondar, Ethiopia
| | - Adeladlew Kassie Netere
- Department of Clinical Pharmacy, School of Pharmacy, College of Medicine and Health Science, University of Gondar, Gondar, Ethiopia
| | - Eyayaw Ashete Belachew
- Department of Clinical Pharmacy, School of Pharmacy, College of Medicine and Health Science, University of Gondar, Gondar, Ethiopia
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Sendekie AK, Teshale AB, Tefera YG. Glycemic control in newly insulin-initiated patients with type 2 diabetes mellitus: A retrospective follow-up study at a university hospital in Ethiopia. PLoS One 2022; 17:e0268639. [PMID: 35617250 PMCID: PMC9135271 DOI: 10.1371/journal.pone.0268639] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/19/2022] [Accepted: 05/04/2022] [Indexed: 01/05/2023] Open
Abstract
Background Though many trials had examined the effectiveness of taking insulin with or without oral agents, there are limited real-world data, particularly among patients with type 2 diabetes mellitus (T2DM) in the resource limited settings. This study aimed to examine level of glycemic control among patients with T2DM after initiation of insulin and factors associated with poor glycemic control. Methods An analysis of retrospective medical records of patients with T2DM who initiated insulin due to uncontrolled hyperglycemia by oral agents was conducted from 2015–2020 in the University of Gondar Comprehensive Specialized Hospital. Difference in median fasting plasma glucose (FPG) before and after insulin initiations was examined by a Wilcoxon signed-rank test. Kruskal Wallis test was performed to explore difference in the median level of FPG among treatment groups. A logistic regression model was also used to identify associated factors of poor glycemic control after insulin initiation. Statistical significance was declared at p < 0.05. Results Of 424 enrolled patients with T2DM, 54.7% were males and the mean age was 59.3±9.3 years. A Wilcoxon signed-rank test showed that there was significant deference in FPG before and after insulin initiation (P < 0.001). A declining trend of blood glucose was observed during the 1-year follow-up period of post-initiation. However, majority of the participants did not achieve target glucose levels. Participants who had higher FPG and systolic blood pressure (SBP) before insulin initiation were found more likely to have poor glycemic control after insulin initiation. Similarly, patients who received atorvastatin compared with simvastatin were found to have poor glycemic control in the post-period of initiation (P = 0.04). Premixed insulin was associated with a lower likelihood of poor glycemic control than neutral protamine Hagedorn (NPH) insulin (P < 0.001). Conclusion Following insulin initiation, a significant change in glycemic level and declining trend of FPG was observed during a 1-year follow-up period. However, the majority of patients still had a poorly controlled glycemic level. Appropriate management focusing on predictors of glycemic control would be of a great benefit to achieve glycemic control.
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Affiliation(s)
- Ashenafi Kibret Sendekie
- Department of Clinical Pharmacy, School of Pharmacy, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia
- * E-mail: ,
| | - Achamyeleh Birhanu Teshale
- Department of Epidemiology and Biostatistics, Institute of Public health, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia
| | - Yonas Getaye Tefera
- Department of Clinical Pharmacy, School of Pharmacy, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia
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Uzoigwe C, Radin M, Hamersky CM, DeKoven M, Holt C, Karkare S, Polonsky WH. Quality of life in patients with type 2 diabetes after switching to insulin degludec: results from a cross-sectional survey. Qual Life Res 2021; 30:1629-1640. [PMID: 33550540 PMCID: PMC8178133 DOI: 10.1007/s11136-020-02753-6] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 12/28/2020] [Indexed: 11/30/2022]
Abstract
PURPOSE Five quality of life (QoL) domains are particularly important to patients with type 2 diabetes (T2D) using basal insulin-sense of physical well-being, sense of safety regarding hypoglycemia, sense of diabetes as burdensome, feelings of freedom and flexibility, and sleep quality. METHODS An online survey assessed these QoL domains in adult patients with T2D in the USA who had switched from a previous basal insulin to insulin degludec (IDeg): modified versions of the World Health Organization (Five) Well-Being Index (WHO-5), Hypoglycemia Attitudes and Behavior Scale (HABS; confidence and anxiety subscales only), and Diabetes Distress Scale (DDS; emotional burden and regimen-related distress subscales only); three items assessing feelings of freedom and flexibility; and one item assessing sleep quality (hours of restful sleep). Patients rated each item for their previous basal insulin and currently while using IDeg. Correlations between sleep quality and the other QoL scales were also assessed. RESULTS In total, 152 patients completed the survey and were included in the study sample. Patients reported significantly improved scores while using IDeg on all WHO-5, DDS, HABS, feelings of freedom and flexibility item scores, and total raw/mean subscale scores (P < 0.0001). Patients also reported a significantly greater number of hours of restful sleep [mean (SD) 6.6 (2.0) vs. 5.5 (1.8); P < 0.0001]. Better sleep quality statistically significantly correlated with improved QoL in all other domains assessed. CONCLUSIONS Treatment with IDeg after switching from a previous basal insulin was associated with statistically significant improvements in all QoL domains assessed.
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Affiliation(s)
- Chioma Uzoigwe
- Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, NJ, 08536, USA.
| | - Michael Radin
- Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, NJ, 08536, USA
| | - Carol M Hamersky
- Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, NJ, 08536, USA
| | | | | | | | - William H Polonsky
- Behavioral Diabetes Institute, San Diego, CA, USA.,University of California, San Diego, CA, USA
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Wieringa TH, de Wit M, Twisk JWR, Snoek FJ. Improving interpretability of individual Diabetes Symptom Checklist-Revised (DSC-R) scores: the role of patient characteristics. BMJ Open Diabetes Res Care 2020; 8:8/1/e001146. [PMID: 32241781 PMCID: PMC7170392 DOI: 10.1136/bmjdrc-2019-001146] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/22/2019] [Revised: 03/02/2020] [Accepted: 03/09/2020] [Indexed: 12/14/2022] Open
Abstract
INTRODUCTION The Diabetes Symptom Checklist-Revised (DSC-R) is a well-validated patient-reported outcome designed to assess symptom burden in persons with type 2 diabetes mellitus (T2DM) across eight domains. The DSC-R has so far primarily been used in research settings. With the aim to make the DSC-R applicable in clinical practice by improving its interpretability, we sought to identify patient characteristics associated with DSC-R (domain) scores as a first initiative toward reference values. RESEARCH DESIGN AND METHODS We used baseline data from two large observational studies to select patient characteristics significantly associated with DSC-R domain and total scores. Multivariable Tobit analyses with the backward procedure per (domain) score were performed. RESULTS Data from 1531 participants with T2DM were included. On a 0-100 scale, the median DSC-R total score was 15.88 (7.06-29.41), with domain scores ranging from 5.00 (0.00-22.50) (pain) to 35.00 (10.00-60.00) (fatigue). Low well-being status was most profoundly associated with higher scores across all domains. Persons with one or more complication, as well as one or more symptomatic hypoglycemic episode during the past 3 months, scored higher on (almost) all domains and the total scale. CONCLUSIONS Complications, symptomatic hypoglycemia, and low well-being are important characteristics to take into account when using the DSC-R in individual patients. Further validation of our findings is warranted in diverse patient populations.
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Affiliation(s)
- Thomas H Wieringa
- Department of Medical Psychology, Amsterdam UMC, Vrije Universiteit, Amsterdam Public Health research institute, Amsterdam, The Netherlands
| | - Maartje de Wit
- Department of Medical Psychology, Amsterdam UMC, Vrije Universiteit, Amsterdam Public Health research institute, Amsterdam, The Netherlands
| | - Jos W R Twisk
- Department of Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit, Amsterdam Public Health research institute, Amsterdam, The Netherlands
| | - Frank J Snoek
- Department of Medical Psychology, Amsterdam UMC, Vrije Universiteit, Amsterdam Public Health research institute, Amsterdam, The Netherlands
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Fritschi C, Park C, Quinn L, Collins EG. Real-Time Associations Between Glucose Levels and Fatigue in Type 2 Diabetes: Sex and Time Effects. Biol Res Nurs 2020; 22:197-204. [PMID: 32008368 DOI: 10.1177/1099800419898002] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/01/2023]
Abstract
OBJECTIVE Fatigue is a pervasive and serious complaint among aging adults with type 2 diabetes. Anecdotally, hyperglycemia was thought to cause fatigue, but prior cross-sectional analyses failed to find any relationship between glucose levels and fatigue. However, study methodology may have caused this relationship to be missed. Our aim was to use concurrent and continuous data across 5 days to examine real-time momentary relationships between glucose and fatigue levels by week, day, and time of day. Additionally, we explored how these relationships differed by sex. METHOD Participants (N = 54, 51% male, 54% non-White) wore continuous glucose monitors and wrist actigraphy into which they inputted fatigue ratings 6-8 times daily during waking hours across 5 days. Generalized estimation equation models were used to explore the relationship between glucose and fatigue when averaged by week, day, and time of day. Differences by sex were also explored. RESULTS HbA1c and baseline and real-time fatigue were higher in women than in men. Baseline HbA1c and self-reported general fatigue were unrelated. Fatigue levels averaged by day and time of day were higher in women than in men (p < .05). Glucose and fatigue were significantly related at all levels of data (weekly, daily, and time of day) in women but not men. CONCLUSIONS Our findings suggest that, when measured concurrently, glucose excursions may affect fatigue levels in women.
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Affiliation(s)
- Cynthia Fritschi
- Department of Biobehavioral Health Science, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA
| | - Chang Park
- College of Nursing, University of Illinois at Chicago, Chicago, IL, USA
| | - Laurie Quinn
- Department of Biobehavioral Health Science, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA
| | - Eileen G Collins
- Department of Biobehavioral Health Science, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA.,Research & Development, Edward Hines, Jr. VA Hospital, Hines, IL, USA
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Upsher R, Allen-Taylor M, Reece I, Chamley M, Ismail K, Forbes A, Winkley K. Experiences of Attending Group Education to Support Insulin Initiation in Type 2 Diabetes: A Qualitative Study. Diabetes Ther 2020; 11:119-132. [PMID: 31732858 PMCID: PMC6965558 DOI: 10.1007/s13300-019-00727-7] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/05/2019] [Indexed: 11/27/2022] Open
Abstract
INTRODUCTION Type 2 diabetes is a progressive condition and many people require insulin therapy 5-10 years post diagnosis. Considering the global increase in type 2 diabetes, group education programmes to initiate insulin are beneficial as they are cost-effective and provide peer support. However, group education to initiate insulin has not been widely evaluated and there is a need to elicit the views and experience of people with type 2 diabetes who start insulin in groups. The aim of this study was to explore the perspectives of people with type 2 diabetes who receive nurse-led group-based insulin education. METHODS Qualitative, semi-structured interviews of people with type 2 diabetes in south London, UK, who had attended group education sessions to start insulin. Inductive thematic analysis identified themes within the data. RESULTS Fifteen people with type 2 diabetes were interviewed. Three main themes were identified: creating a supportive environment; facilitator skills; and effectiveness of group. Factors which created a supportive environment included peer support, providing reassurance and printed materials. Facilitator skills associated with positive experiences included addressing negative insulin beliefs and managing group dynamics. The effectiveness of the group was determined by ongoing self-management success, need for more peer support, and insulin concerns post insulin education group. CONCLUSION Positive experiences of insulin group education for people with type 2 diabetes were associated with sharing experiences with other people starting insulin, reassurance from healthcare professionals, appropriate supportive materials, and skill of the facilitator to address insulin concerns and manage group dynamics. People with type 2 diabetes may benefit more from education if healthcare professionals are skilled in psychological techniques to facilitate group education aimed at addressing concerns around insulin therapy. Further research needs to assess the effectiveness of structured insulin group education for people with type 2 diabetes.
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Affiliation(s)
- Rebecca Upsher
- Diabetes, Psychiatry, and Psychology, Department of Psychological Medicine, King's College London and Institute of Psychiatry, Psychology and Neuroscience, London, UK.
| | - Maya Allen-Taylor
- Florence Nightingale Faculty of Nursing and Midwifery and Palliative Care, King's College London, London, UK
| | - Ilse Reece
- Florence Nightingale Faculty of Nursing and Midwifery and Palliative Care, King's College London, London, UK
| | - Mark Chamley
- Lambeth Clinical Commissioning Group Diabetes Intermediate Care Team, South London, London, UK
| | - Khalida Ismail
- Diabetes, Psychiatry, and Psychology, Department of Psychological Medicine, King's College London and Institute of Psychiatry, Psychology and Neuroscience, London, UK
| | - Angus Forbes
- Florence Nightingale Faculty of Nursing and Midwifery and Palliative Care, King's College London, London, UK
| | - Kirsty Winkley
- Florence Nightingale Faculty of Nursing and Midwifery and Palliative Care, King's College London, London, UK
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Davis TME, Bruce DG, Curtis BH, Barraclough H, Davis WA. The relationship between intensification of blood glucose-lowering therapies, health status and quality of life in type 2 diabetes: The Fremantle Diabetes Study Phase II. Diabetes Res Clin Pract 2018; 142:294-302. [PMID: 29879496 DOI: 10.1016/j.diabres.2018.05.047] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/03/2018] [Revised: 05/25/2018] [Accepted: 05/30/2018] [Indexed: 10/14/2022]
Abstract
AIMS To determine whether therapeutic intensification in type 2 diabetes influences health status and quality of life (QoL). METHODS We studied 930 participants in the longitudinal observational Fremantle Diabetes Study Phase II (mean age 65.3 years, 53.8% males, median diabetes duration 8.0 years) with valid data from baseline assessment and two biennial reviews (4 years of follow-up) between 2008 and 2015. The main outcome measures were the Short Form-12 version 2 physical and mental health composite scores (PCS, MCS) and the average weighted impact (AWI) score from the Audit of Diabetes Dependent QoL. RESULTS There were reductions in PCS at Year 4 compared with baseline and Year 2 in patients on stable diet-based management (n = 160), oral glucose-lowering medication (OGLM; n = 387), and insulin with/without OGLM (n = 168; P < 0.05), but no statistically significant temporal changes in MCS/AWI. Insulin-treated patients had the lowest PCS, MCS and AWI compared to the other two subgroups at each time-point (P ≤ 0.012). In participants initiating OGLM (n = 84) or insulin (n = 85), there were no differences in PCS, MCS or AWI at the biennial assessments either side of these therapeutic changes (P ≥ 0.08). CONCLUSIONS These real-life data show that treatment intensification, including insulin initiation, does not impact adversely on patient well-being in community-based type 2 diabetes. Since insulin use at entry was associated with longer diabetes duration, worse glycaemic control, and a greater risk of chronic complications, the burden of disease rather than treatment modality appears the primary determinant of health status and QoL.
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Affiliation(s)
- Timothy M E Davis
- Medical School, University of Western Australia, Fremantle Hospital, Fremantle, Western Australia, Australia.
| | - David G Bruce
- Medical School, University of Western Australia, Fremantle Hospital, Fremantle, Western Australia, Australia
| | - Bradley H Curtis
- Eli Lilly Australia and New Zealand, 112 Wharf Rd, West Ryde, NSW, Australia
| | - Helen Barraclough
- Eli Lilly Australia and New Zealand, 112 Wharf Rd, West Ryde, NSW, Australia
| | - Wendy A Davis
- Medical School, University of Western Australia, Fremantle Hospital, Fremantle, Western Australia, Australia
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Weatherall J, Polonsky WH, Lanar S, Knoble N, Håkan-Bloch J, Constam E, Philis-Tsimikas A, Marrel A. When insulin degludec enhances quality of life in patients with type 2 diabetes: a qualitative investigation. Health Qual Life Outcomes 2018; 16:87. [PMID: 29720273 PMCID: PMC5932896 DOI: 10.1186/s12955-018-0883-1] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/11/2017] [Accepted: 03/25/2018] [Indexed: 11/16/2022] Open
Abstract
Background Anecdotal reports suggest that insulin degludec (IDeg) may offer unique health-related quality of life (HRQoL) benefits. As the nature of these benefits remain unclear, this study utilized qualitative research methods to investigate and elucidate the experience of “feeling better” after initiating IDeg. Methods Twenty adults with type 2 diabetes (T2D) who reported “feeling better” on IDeg for > 3 months participated in 90-min interviews. One focus group and nine telephone interviews were conducted at two sites in the United States (US) and one focus group was conducted in Switzerland. Patients were ≥ 18 years of age, did not take mealtime insulin, and had switched to IDeg from another basal insulin. Discussions were audio-recorded, transcribed and translated (Swiss German). Utilizing grounded theory, transcripts were analyzed by sorting quotes into concepts using thematic analysis. Results Participants' mean age was 66 years and the average duration of T2D was 17.6 years. Mean duration of IDeg use was 1.45 years. Four major factors were identified as key contributors to patients’ sense of “feeling better”: 1) reduced sense of diabetes as burdensome and requiring excessive attention; 2) enhanced feelings of adaptability and freedom; 3) heightened sense of security, especially regarding concerns about hypoglycemia; and 4) greater sense of physical well-being (greater energy/less fatigue). Content saturation was achieved. Generally, patients from the US sites were more focused on medical results than Swiss patients, who were more likely to identify IDeg’s effect on overall HRQoL. A limitation of the study was that the population was primarily white, > 60 and otherwise healthy (no comorbid physical or mental condition). Conclusions A group of patients with T2D, who had switched to IDeg from another basal insulin, reported HRQoL benefits which were attributed to both diabetes-specific improvements (feeling less burdened by day-to-day diabetes demands) and non-specific gains (greater energy). The conclusions may have limited transferability due to the characteristics of the sample population and further research is needed.
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Affiliation(s)
| | - William H Polonsky
- Behavioral Diabetes Institute, San Diego, CA, USA.,University of California, San Diego, CA, USA
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12
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Lee KP. Translation and validation of the Insulin Treatment Appraisal Scale in Hong Kong primary care patients. J Diabetes Investig 2018; 9:311-320. [PMID: 28626953 PMCID: PMC5835470 DOI: 10.1111/jdi.12704] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/13/2017] [Revised: 05/22/2017] [Accepted: 06/04/2017] [Indexed: 11/24/2022] Open
Abstract
AIMS/INTRODUCTION Patients with type 2 diabetes mellitus often delay the initiation or titration of insulin treatment due to psychological factors. This phenomenon is referred to as psychological insulin resistance (PIR). The Insulin Treatment Appraisal Scale (ITAS) is a 20-item instrument for assessing PIR. A previous Chinese version of the ITAS (C-ITAS) was found to be subject to problems arising from its translation. The present study aimed to translate and validate this instrument, which will facilitate research and aid in counseling in a clinical setting. MATERIALS AND METHODS The C-ITAS was modified to develop the Hong Kong version of the C-ITAS (C-ITAS-HK) according to published guidelines for the translation of transcultural research. A total of 328 diabetes mellitus patients who were followed-up in 10 different publically funded primary care outpatient clinics were recruited for self-administration of the C-ITAS-HK. Demographic data were recorded, and clinical data (e.g., presence of diabetes mellitus complications) were obtained from case records. The C-ITAS-HK results were subjected to psychometric analysis, including the assessment of Cronbach's alpha, factor analysis and test-retest reliability. RESULTS Factor analysis supported a two-factor structure with good internal consistency (whole scale 0.846, negative subscale 0.882, positive subscale 0.619). The test-retest reliability correlation coefficients for all items were positive, at 0.871, 0.782, and 0.692 for the whole scale, negative subscale and positive subscale, respectively. The ITAS scores differed significantly between participants with PIR and those without in the expected direction, suggesting good discriminant validity. CONCLUSIONS The C-ITAS-HK is a valid tool for measuring and assessing PIR in the Hong Kong primary care diabetes mellitus population.
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Affiliation(s)
- Kam Pui Lee
- Jockey Club School of Public Health and Primary CareThe Chinese University of Hong KongShatinHong Kong
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Wieringa TH, de Wit M, Twisk JWR, Snoek FJ. Does hypoglycaemia affect the improvement in QoL after the transition to insulin in people with type 2 diabetes? J Endocrinol Invest 2018; 41:249-258. [PMID: 28803366 PMCID: PMC5785617 DOI: 10.1007/s40618-017-0744-5] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/21/2017] [Accepted: 08/07/2017] [Indexed: 11/19/2022]
Abstract
PURPOSE Quality of Life (QoL) of insulin-naïve people with type 2 diabetes mellitus (T2DM) improves after transition to insulin. Little is known about the role of hypoglycaemia in this context. Secondary analyses of the Study of the Psychological Impact in Real care of Initiating insulin glargine Treatment (SPIRIT) aimed to investigate the relationship between hypoglycaemia and QoL when transitioning to insulin. METHODS Insulin-naïve Dutch people with T2DM in suboptimal glycaemic control (HbA1c >53 mmol/mol; 7.0%) on maximum dose of oral glucose-lowering medications were included from 363 primary care practices (n = 911). Participants started insulin glargine and completed QoL-questionnaires (WHO-5 Well-being Index (WHO-5; emotional well-being), Hypoglycaemia Fear Survey-worry scale (HFS-w; hypoglycaemia fear) and Diabetes Symptom Checklist-revised (DSC-r; diabetes symptom distress) at baseline, 3 and 6 months follow-up. Linear GEE analyses were used to investigate the association between symptomatic, nocturnal, severe hypoglycaemia (number of episodes during 3 months prior to visit) and QoL over time. RESULTS 52.5% men participated, mean age 62.2 years (SD ± 10.92), and median HbA1c 67 mmol/mol (range 61-77) (8.3%). More symptomatic hypoglycaemic episodes were associated with higher HFS-w and DSC-r scores (P < 0.01). Experiencing multiple nocturnal or severe episodes was related to higher symptom distress as well, when compared to no episodes. These associations did not change significantly over time. CONCLUSIONS Hypoglycaemia is associated with lower QoL in terms of hypoglycaemia fear and diabetes symptom distress. The transition to insulin does not affect this relationship, suggesting hypoglycaemia in itself has a detrimental effect on diabetes-related QoL independent of treatment regimen.
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Affiliation(s)
- T. H. Wieringa
- Department of Medical Psychology, VU University Medical Center (VUMC), De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands
- Amsterdam Public Health Research Institute, Amsterdam, The Netherlands
| | - M. de Wit
- Department of Medical Psychology, VU University Medical Center (VUMC), De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands
- Amsterdam Public Health Research Institute, Amsterdam, The Netherlands
| | - J. W. R. Twisk
- Amsterdam Public Health Research Institute, Amsterdam, The Netherlands
- Department of Clinical Epidemiology and Biostatistics, VU University Medical Center (VUMC), De Boelelaan 1089a, 1081 HV Amsterdam, The Netherlands
| | - F. J. Snoek
- Department of Medical Psychology, VU University Medical Center (VUMC), De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands
- Amsterdam Public Health Research Institute, Amsterdam, The Netherlands
- Department of Medical Psychology, Academic Medical Center (AMC), Meibergdreef 9, 1100 DD Amsterdam, The Netherlands
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Tang TS, Yusuf FLA, Polonsky WH, Fisher L. Assessing quality of life in diabetes: II - Deconstructing measures into a simple framework. Diabetes Res Clin Pract 2017; 126:286-302. [PMID: 28190527 DOI: 10.1016/j.diabres.2016.10.007] [Citation(s) in RCA: 18] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/24/2016] [Accepted: 10/13/2016] [Indexed: 12/19/2022]
Abstract
A growing number of instruments measuring diabetes-specific health-related quality of life (HRQOL) have been identified in previous systematic reviews, the most recent being published in 2008. The purpose of this paper is report on an updated systematic review of diabetes-specific HRQOL measures highlighting the time period 2006-2016; to deconstruct existing diabetes-specific HRQOL measures into a simple framework for evaluating the goodness-of-fit between specific research needs and instrument characteristics; and to present core characteristics of measures not yet reported in other reviews to further facilitate scale selection. Using the databases Medline, Pubmed, CINAHL, OVID Embase, and PsycINFO, we identified 20 diabetes-specific HRQOL measures that met our inclusion criteria. For each measure, we extracted eight core characteristics for our measurement selection framework. These characteristics include target population (type 1 vs. type 2), number and type of HRQOL dimensions measured and scored, type of score and calculation algorithm, sensitivity to change data reported in subsequent studies, number of survey items, approximate time length to complete, number of studies using the instrument in the past 10years, and specific languages instruments is translated. This report provides a way to compare and contrast existing diabetes-specific HRQOL measures to aid in appropriate scale selection and utilization.
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Affiliation(s)
| | | | - William H Polonsky
- Behavioral Diabetes Institute, San Diego, CA, USA; University of California, San Diego, CA, USA
| | - Lawrence Fisher
- University of California, San Francisco, San Francisco, CA, USA
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15
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Furler J, O'Neal D, Speight J, Manski-Nankervis JA, Gorelik A, Holmes-Truscott E, Ginnivan L, Young D, Best J, Patterson E, Liew D, Segal L, May C, Blackberry I. Supporting insulin initiation in type 2 diabetes in primary care: results of the Stepping Up pragmatic cluster randomised controlled clinical trial. BMJ 2017; 356:j783. [PMID: 28274941 PMCID: PMC6287657 DOI: 10.1136/bmj.j783] [Citation(s) in RCA: 42] [Impact Index Per Article: 5.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
Objective To compare the effectiveness of a novel model of care ("Stepping Up") with usual primary care in normalising insulin initiation for type 2 diabetes, leading to improved glycated haemoglobin (HbA1c) levels.Design Cluster randomised controlled trial.Setting Primary care practices in Victoria, Australia, with a practice nurse and at least one consenting eligible patient (HbA1c ≥7.5% with maximal oral treatment).Participants 266 patients with type 2 diabetes and 74 practices (mean cluster size 4 (range 1-8) patients), followed up for 12 months.Intervention The Stepping Up model of care intervention involved theory based change in practice systems and reorientation of the roles of health professionals in the primary care diabetes team. The core components were an enhanced role for the practice nurse in leading insulin initiation and mentoring by a registered nurse with diabetes educator credentials.Main outcome measures The primary endpoint was change in HbA1c. Secondary endpoints included the proportion of participants who transitioned to insulin, proportion who achieved target HbA1c, and a change in depressive symptoms (patient health questionnaire, PHQ-9), diabetes specific distress (problem areas in diabetes scale, PAID), and generic health status (assessment of quality of life instrument, AQoL-8D).Results HbA1c improved in both arms, with a clinically significant between arm difference (mean difference -0.6%, 95% confidence interval -0.9% to -0.3%), favouring the intervention. At 12 months, in intervention practices, 105/151 (70%) of participants had started insulin, compared with 25/115 (22%) in control practices (odds ratio 8.3, 95% confidence interval 4.5 to 15.4, P<0.001). Target HbA1c (≤7% (53 mmol/mol)) was achieved by 54 (36%) intervention participants and 22 (19%) control participants (odds ratio 2.2, 1.2 to 4.3, P=0.02). Depressive symptoms did not worsen at 12 months (PHQ-9: -1.1 (3.5) v -0.1 (2.9), P=0.05). A statistically significant difference was found between arms in the mean change in mental health (AQoL mental component summary: 0.04 (SD 0.16) v -0.002 (0.13), mean difference 0.04 (95% confidence interval 0.002 to 0.08), P=0.04), favouring the intervention, but no significant difference in physical health (AQoL physical component summary: 0.03 (0.15) v 0.02 (0.13)) nor diabetes specific distress (5.6 (15.5) v -2.4 (15.4)). No severe hypoglycaemia events were reported.Conclusions The Stepping Up model of care was associated with increased insulin initiation rates in primary care, and improvements in glycated haemoglobin without worsening emotional wellbeing.Trial registration Australian and New Zealand Clinical Trials Registry ACTRN12612001028897.
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Affiliation(s)
- John Furler
- Department of General Practice, University of Melbourne, Carlton, Melbourne, VIC, 3053, Australia
| | - David O'Neal
- Department of Medicine, St Vincent's Hospital, University of Melbourne, Melbourne, Australia
| | - Jane Speight
- School of Psychology, Deakin University, Victoria, Australia
- The Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Victoria, Australia
- AHP Research, United Kingdom
| | - Jo-Anne Manski-Nankervis
- Department of General Practice, University of Melbourne, Carlton, Melbourne, VIC, 3053, Australia
| | - Alexandra Gorelik
- Melbourne EpiCentre, the University of Melbourne, Melbourne, Australia
| | - Elizabeth Holmes-Truscott
- School of Psychology, Deakin University, Victoria, Australia
- The Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Victoria, Australia
| | - Louise Ginnivan
- School of Psychology, Deakin University, Victoria, Australia
| | - Doris Young
- Department of General Practice, University of Melbourne, Carlton, Melbourne, VIC, 3053, Australia
- Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia
| | - James Best
- Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore
| | | | - Danny Liew
- School of Public Health and Preventive Medicine, Monash University, Australia
| | - Leonie Segal
- Health Economics and Social Policy Group, Division of Health Sciences, University of South Australia, Adelaide, Australia
| | - Carl May
- Faculty of Health Sciences, University of Southampton, Southampton, UK
| | - Irene Blackberry
- John Richards Initiative, Australian Institute for Primary Care and Ageing, College of Science, Health and Engineering, La Trobe University, Melbourne, Australia
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Abstract
OBJECTIVE To investigate the impact associated with mild hypoglycemia among patients with type 2 diabetes (T2DM) in the United States and to identify risk factors among different subpopulations. METHODS We performed a literature search to gather available data allowing estimation of rates of mild hypoglycemia. Because risk factors are interdependent, risk factors included in the model were based on those reported within multivariate analyses or judged to be biologically plausible by the medical community. Based on literature search results, we built a mathematical model predicting the rates of mild hypoglycemia in individual patients as a function of the patient's antidiabetic medications, hemoglobin A1c levels, duration of diabetes, kidney function, and body mass index. RESULTS We estimated an overall average rate of mild hypoglycemia among US patients with T2DM of 2.2 ± 0.8 events per person per year. Patients taking oral antidiabetic medications only had an average rate of 1.9 ± 0.8 events per person per year. The average rate for all patients taking insulin, including those combining it with other antidiabetic medications, was 4.9 ± 2.0 events per person per year. Mild hypoglycemia rates increased with age, with 80-year-old patients experiencing 1.5 times the risk of 40-year-old patients. Based on published values for direct and indirect medical costs for mild hypoglycemia events, we determined that the economic impact in the US of mild hypoglycemic events is approximately $900 million per year, roughly equal to that of severe hypoglycemic events. One of the key limitations to our model is that it applies to the US population under standard medical care and not to clinical trials and does not include certain known risk factors such as rigorous exercise. CONCLUSIONS Understanding the benefit versus risk of glycemic control and hypoglycemia is fundamental to the successful management of patients with T2DM. Our validated hypoglycemia model is an important step in addressing this issue and may be helpful to researchers, clinicians, and payers to determine the patients who are at the highest risk for hypoglycemia, whether a patient is experiencing events at 'higher-than-expected' rates, and the corresponding economic burden.
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Home P, Baik SH, Gálvez GG, Malek R, Nikolajsen A. An analysis of the cost-effectiveness of starting insulin detemir in insulin-naïve people with type 2 diabetes. J Med Econ 2015; 18:230-40. [PMID: 25407031 DOI: 10.3111/13696998.2014.985788] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/09/2022]
Abstract
AIMS There is limited evidence with respect to the cost-effectiveness of starting insulin in people with diabetes outside the 'western' world. The aim of this study was to assess the cost-effectiveness of starting basal insulin treatment with insulin detemir in people with type 2 diabetes (T2D) inadequately controlled on oral glucose-lowering drugs (OGLDs) in Mexico, South Korea, India, Indonesia, and Algeria. METHODS The IMS CORE Diabetes Model was used to project clinical and cost outcomes over a 30-year time horizon. Clinical outcomes, baseline characteristics and health state utility data were taken from the A1chieve study. A 1-year analysis was also conducted based on treatment costs and quality-of-life data. Incremental cost-effectiveness ratios (ICERs) were expressed as a fraction of GDP per capita, and WHO-CHOICE recommendations (ICER < 3.0) used to define cost-effectiveness. RESULTS Starting insulin detemir was associated with a projected increase in life expectancy (≥1 year) and was considered cost-effective in all of the studied populations with ICERs of -0.02 (Mexico), 0.00 (South Korea), 0.48 (India), 0.12 (Indonesia), and 0.88 (Algeria) GDP/quality-adjusted life-year. Cost-effectiveness was maintained after conducting sensitivity analyses in the 30-year and 1-year analyses. A projected increase in treatment costs was partially offset by a reduction in complications. The difference in overall costs between insulin detemir and OGLDs alone was USD518, 1431, 3510, 15, and 5219, respectively. CONCLUSION Changes in clinical outcomes associated with starting insulin detemir in insulin-naïve individuals with T2D resulted in health gains that made the intervention cost-effective in five countries with distinct healthcare resources.
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Affiliation(s)
- Philip Home
- The Medical School, Newcastle University , Newcastle upon Tyne , UK
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18
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Polonsky WH, Thompson S, Wei W, Riddle MC, Chaudhari S, Jackson J, Bruno AS. Greater fear of hypoglycaemia with premixed insulin than with basal-bolus insulin glargine and glulisine: patient-reported outcomes from a 60-week randomised study. Diabetes Obes Metab 2014; 16:1121-7. [PMID: 24919603 DOI: 10.1111/dom.12328] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/27/2014] [Revised: 05/21/2014] [Accepted: 06/10/2014] [Indexed: 11/29/2022]
Abstract
AIM To assess the effect of initiating insulin treatment on quality of life of patients with type 2 diabetes (T2DM) in the 60-week All-to-Target trial (NCT00384085). METHODS Patient-reported outcomes from a phase IV, multicentre, randomised, open-label, parallel-group study were analysed. Participants were randomised to: insulin glargine with up to one insulin glulisine injection (G + 1); insulin glargine with stepwise addition of up to three insulin glulisine injections (G + 3); or twice-daily premixed 70/30 insulin protamine-aspart/aspart (PM-2). Patient-reported outcome questionnaires were administered at weeks 0, 6, 12, 24, 36, 48 and 60. RESULTS There were no between-group differences in the Psychosocial Adjustment to Illness State-Self Report (PAIS-SR) or in the EuroQoL Group Five-Dimension Self-Report Index Questionnaire (EQ-5D) from baseline to week 60; however, PAIS-SR scores improved significantly over this period in the G + 3 group (p = 0.0016) and EQ-5D scores worsened significantly in the PM-2 group (p = 0.02). Hypoglycemia Fear Survey Behaviour and Worry subscales worsened significantly for all groups, with greater deterioration being observed in the PM-2 group than in the G + 1 group (Behaviour, p = 0.0050; Worry, p = 0.0017) and G + 3 groups (Behaviour, p = 0.0105; Worry, p = 0.0016). Total scores on the Diabetes Quality of Life (DQoL) questionnaire improved more in the G + 3 group than in the PM-2 group over the study period (p = 0.0284), with all groups showing a significant improvement in DQoL score over time. CONCLUSION Insulin glargine-based regimens showed advantages over premixed insulin in a number of patient-reported outcome measures. The potential impact on fear of hypoglycaemia may be of particular relevance when addressing the major barriers to early insulin treatment.
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Affiliation(s)
- W H Polonsky
- Department of Psychiatry, University of California and Behavioral Diabetes Institute, San Diego, CA, USA
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Polonsky W, Traylor L, Wei W, Shi R, Ameer B, Vlajnic A, Nicolucci A. More satisfied, but why? A pooled patient-level analysis of treatment satisfaction following the initiation of insulin glargine vs. comparators in insulin-naïve patients with type 2 diabetes mellitus. Diabetes Obes Metab 2014; 16:255-61. [PMID: 24028669 DOI: 10.1111/dom.12214] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/04/2013] [Revised: 05/21/2013] [Accepted: 09/08/2013] [Indexed: 11/30/2022]
Abstract
AIM To assess patient-reported outcomes associated with initiating insulin glargine among insulin-naïve patients with type 2 diabetes mellitus (T2DM). METHODS This was a pooled analysis of patient-level data from Phase 3, randomized controlled trials evaluating once-daily insulin glargine vs. comparator treatment for ≥24 weeks in previously insulin-naïve adult patients with T2DM and poor glycaemic control. Eligible studies utilized strict, predefined insulin titration algorithms with weekly dose-adjustment to achieve fasting plasma glucose (FPG) levels of ≤5.6 mmol/l. Treatment satisfaction was measured using the Diabetes Treatment Satisfaction Questionnaire (DTSQ) change (c) and status (s) versions. RESULTS A total of 1577 patients from four studies were included; 830 patients treated with insulin glargine and 747 with comparators. At week 24, DTSQc scores improved in both groups with a significantly higher increase in treatment satisfaction for insulin glargine vs. comparators (13.5 vs. 12.1; p < 0.0001). Multivariate regression analysis revealed that significant predictors of DTSQc improvement at week 24 were insulin glargine treatment (p < 0.0001), higher baseline DTSQs (p < 0.0001), and lower baseline body weight (p = 0.0103). Greater improvement in DTSQc at week 24 was significantly associated with decrease from baseline in glycosylated haemoglobin (p < 0.001) and FPG (p = 0.0001); a numerically more positive change in weight from baseline approached significance (p = 0.07). CONCLUSION Initiation of insulin glargine in insulin-naïve patients with T2DM is associated with greater improvements in treatment satisfaction than alternative interventions, with perceived improvements in glycaemic control and baseline weight likely to be important factors.
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Affiliation(s)
- W Polonsky
- University of California, San Diego, CA, USA
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20
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Curtis B, Lage MJ. Glycemic control among patients with type 2 diabetes who initiate basal insulin: a retrospective cohort study. J Med Econ 2014; 17:21-31. [PMID: 24195723 DOI: 10.3111/13696998.2013.862538] [Citation(s) in RCA: 21] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/09/2022]
Abstract
OBJECTIVE To examine changes in glycemic control for patients with type 2 diabetes mellitus (T2DM) after initiation of basal insulin and factors associated with improved glycemic control. METHODS An analysis of retrospective medical records of patients with T2DM was examined using Humedica's electronic medical records database (January 2007-August 2012). Patients with T2DM, initiating basal insulin, age ≥ 21 years, with a recorded HbA1c test in both the 1 year prior and the 2 years post-initiation were included. A multivariate regression examined factors associated with changes in glycemic control. Logistic regressions examined factors associated with improvements or worsening of glycemic control, compared to relatively unchanged glycemic control. RESULTS Many (14,457) individuals met the inclusion-exclusion criteria. Multivariate analyses revealed that older age (p < 0.0001), residence in the Western region of the US (vs South) (p < 0.0001), Medicare insurance vs Medicaid or being uninsured (p = 0.0138), and higher household income (p = 0.0065) were associated with improved glycemic control. Patients diagnosed with comorbid peripheral vascular disease (p = 0.0072), cancer (p = 0.0019), obesity (p = 0.0002), moderate (p = 0.0103), and severe chronic kidney disease (p < 0.0001), or end-stage renal disease (p = 0.0075) in the pre-period were found to have significantly improved glycemic control in the post-period. Use of prandial insulin (p = 0.0087), pre-mix insulin (p = 0.0003) in the pre-period, a higher pre-period HbA1c score (p < 0.0001), and longer duration between pre-period and post-period HbA1c testing (p < 0.0001) were significantly associated with higher HbA1c levels in the post-period. LIMITATIONS Analyses rely on electronic medical records which cannot capture patient healthcare utilization occurring outside of the data capture system. Analyses do not control for insulin dosage or type of basal insulin prescribed. CONCLUSIONS Among patients with T2DM treated with basal insulin, a number of factors may influence glycemic outcomes. These findings suggest a role for a more personalized approach to the treatment of patients with T2DM.
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Affiliation(s)
- Bradley Curtis
- Global Health Outcomes, Eli Lilly and Company , Indianapolis, IN , USA
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Hajós TRS, Polonsky WH, Pouwer F, Gonder-Frederick L, Snoek FJ. Toward defining a cutoff score for elevated fear of hypoglycemia on the hypoglycemia fear survey worry subscale in patients with type 2 diabetes. Diabetes Care 2014; 37:102-8. [PMID: 23990513 DOI: 10.2337/dc13-0971] [Citation(s) in RCA: 45] [Impact Index Per Article: 4.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/03/2023]
Abstract
OBJECTIVE To determine a cutoff score for clinically meaningful fear of hypoglycemia (FoH) on the Hypoglycemia Fear Survey Worry subscale (HFS-W). RESEARCH DESIGN AND METHODS Data on the HFS-W, history of hypoglycemia, emotional well-being (World Health Organization-5 well-being index), and distress about diabetes symptoms (Diabetes Symptom Checklist-Revised) were available from Dutch patients with type 2 diabetes who were treated with oral medication or insulin (n = 1,530). Four criteria were applied to define a threshold for clinically meaningful FoH: 1) modal score distribution (MD criterion), 2) scores 2 SDs above the mean (SD criterion), 3) concurrent validity with severe hypoglycemia and suboptimal well-being (CV criterion), and 4) an elevated score (≥3) on more than one HFS-W item (elevated item endorsement [EI criterion]). Associations between the outcomes of these approaches and a history of severe hypoglycemia and suboptimal well-being were studied. RESULTS Of the 1,530 patients, 19% had a HFS-W score of 0 (MD criterion), and 5% reported elevated FoH (HFS-W ≥ mean + 2 SD; SD criterion). Patients with severe hypoglycemia reported higher HFS-W scores than those without (25 ± 20 vs. 15 ± 17; P < 0.001). Patients with suboptimal well-being reported higher HFS-W scores than those with satisfactory well-being (20 ± 18 vs. 13 ± 15; P < 0.001, CV criterion). Elevated FoH (defined by the EI criterion) was seen in 26% of patients. The SD and EI criteria were the strongest associated with history of severe hypoglycemia. The EI criterion was the strongest associated with suboptimal well-being. CONCLUSIONS Although no definite cutoff score has been determined, the EI criterion may be most indicative of clinically relevant FoH in this exploratory study. Further testing of the clinical relevance of this criterion is needed.
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Liebl A, Andersen H, Svendsen AL, Vora J, Yale JF. Resource utilisation and quality of life following initiation of insulin detemir in patients with type 2 diabetes mellitus. Int J Clin Pract 2013; 67:740-9. [PMID: 23869677 DOI: 10.1111/ijcp.12133] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/26/2012] [Accepted: 01/21/2013] [Indexed: 01/22/2023] Open
Abstract
OBJECTIVE Barriers to insulin initiation in type 2 diabetes mellitus (T2DM) include fear of treatment complexity and perceived lack of time and resources by primary care physicians. The SOLVE study investigated the effect of insulin initiation on resource utilisation and patient quality of life. METHODS SOLVE was a 24-week cohort study in 10 countries evaluating the safety and effectiveness of initiating once-daily insulin detemir in patients with T2DM. Patient quality of life was assessed using the Insulin Treatment Appraisal Scale (ITAS). RESULTS A total of 14,611 (84%) patients completed the 24-week study. During the study, HbA1c improved by 1.3 ± 1.5%. The corresponding insulin dose increased from 13 ± 6 IU (0.16 ± 0.09 IU/kg) at baseline, to 22 ± 16 IU (0.27 ± 0.17 IU/kg) at final visit. FlexPen was the preferred device (63%) for insulin administration. The time taken to teach patients to self-inject and perform dose self-adjustment was 15 ± 13 min and 11 ± 11 min, respectively. The quality of life analysis included 6875 patients. The addition of insulin was associated with an improvement in mean ITAS score [-3.5 (95% CI -3.8, -3.3), p < 0.001]. Physicians reported the use or self-adjustment of insulin detemir as easy or very easy in 79% of participants; and satisfaction with the level of glycaemic control was reported for 74% of patients. CONCLUSIONS Initiating basal insulin therapy resulted in a substantial decrease in HbA1c and improved patients' perceptions of insulin treatment.
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Affiliation(s)
- A Liebl
- Center for Diabetes and Metabolism, m&i-Fachklinik Bad Heilbrunn, Bad Heilbrunn, Germany.
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Venskutonyte L, Brismar K, Rydén-Bergsten T, Rydén L, Kjellström B. Satisfaction with glucose-lowering treatment and well-being in patients with type 2 diabetes and myocardial infarction: a DIGAMI2 QoL sub-study. Diab Vasc Dis Res 2013. [PMID: 23188892 DOI: 10.1177/1479164112463711] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/26/2023] Open
Abstract
The second Diabetes Glucose and Myocardial Infarction (DIGAMI 2) study randomised patients with diabetes and myocardial infarction to insulin or oral-based treatment. To determine the effects of insulin-based treatment, the Diabetes Treatment Satisfaction Questionnaire (DTSQ) and the Psychological General Well-Being (PGWB) Index were administered at baseline and 12 months. Insulin-treated patients (n = 197) had a worse risk profile and more co-morbidity at baseline than patients on oral glucose-lowering agents (n = 127). The treatment satisfaction and psychological well-being was similar between insulin and oral groups at baseline [DTSQ: median (first-third quartile) 30 (24-34) vs 31 (27-34), NS; PGWB: 77 (73-82) vs 79 (76-82), NS] and at 12 months [DTSQ: 32 (28-35) vs 34 (30-36), NS; PGWB: 81 (78-84) vs 82 (78-84), NS]. Improvement was significant in both groups. Insulin-based therapy was well accepted and did not decrease treatment satisfaction or psychological well-being compared to oral glucose-lowering treatment in patients with type 2 diabetes and myocardial infarction.
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Affiliation(s)
- Laura Venskutonyte
- Cardiology Unit, Department of Medicine, Karolinska Institutet, Stockholm, Sweden.
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Spriensma AS, Hajos TRS, de Boer MR, Heymans MW, Twisk JWR. A new approach to analyse longitudinal epidemiological data with an excess of zeros. BMC Med Res Methodol 2013; 13:27. [PMID: 23425202 PMCID: PMC3599839 DOI: 10.1186/1471-2288-13-27] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/19/2012] [Accepted: 02/15/2013] [Indexed: 12/04/2022] Open
Abstract
Background Within longitudinal epidemiological research, ‘count’ outcome variables with an excess of zeros frequently occur. Although these outcomes are frequently analysed with a linear mixed model, or a Poisson mixed model, a two-part mixed model would be better in analysing outcome variables with an excess of zeros. Therefore, objective of this paper was to introduce the relatively ‘new’ method of two-part joint regression modelling in longitudinal data analysis for outcome variables with an excess of zeros, and to compare the performance of this method to current approaches. Methods Within an observational longitudinal dataset, we compared three techniques; two ‘standard’ approaches (a linear mixed model, and a Poisson mixed model), and a two-part joint mixed model (a binomial/Poisson mixed distribution model), including random intercepts and random slopes. Model fit indicators, and differences between predicted and observed values were used for comparisons. The analyses were performed with STATA using the GLLAMM procedure. Results Regarding the random intercept models, the two-part joint mixed model (binomial/Poisson) performed best. Adding random slopes for time to the models changed the sign of the regression coefficient for both the Poisson mixed model and the two-part joint mixed model (binomial/Poisson) and resulted into a much better fit. Conclusion This paper showed that a two-part joint mixed model is a more appropriate method to analyse longitudinal data with an excess of zeros compared to a linear mixed model and a Poisson mixed model. However, in a model with random slopes for time a Poisson mixed model also performed remarkably well.
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Affiliation(s)
- Alette S Spriensma
- Department of Epidemiology and Biostatistics, VU University Medical Center, P.O. Box 7057, Amsterdam 1007 MB, The Netherlands.
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Shah S, Zilov A, Malek R, Soewondo P, Bech O, Litwak L. Improvements in quality of life associated with insulin analogue therapies in people with type 2 diabetes: results from the A1chieve observational study. Diabetes Res Clin Pract 2011; 94:364-70. [PMID: 22153568 DOI: 10.1016/j.diabres.2011.10.020] [Citation(s) in RCA: 37] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/20/2011] [Revised: 10/10/2011] [Accepted: 10/13/2011] [Indexed: 11/22/2022]
Abstract
AIMS To determine the effects on quality of life after starting insulin with, or switching to, insulin analogue therapies in the 24-week, prospective, non-interventional, observational A(1)chieve study conducted across four continents in people with type 2 diabetes. METHODS Health-related quality of life (HRQoL) was assessed at baseline and at 24 weeks by the validated EQ-5D questionnaire (visual analogue score [VAS] and five dimensions) in 66,726 people who had started using basal insulin detemir, mealtime insulin aspart (with or without a basal insulin) or biphasic insulin aspart 30. RESULTS For the overall cohort, reported HRQoL increased significantly by 13.8 points from 63.4 points at baseline to 77.2 points at 24 weeks (p<0.001) (scale 1-100, 100=best health imaginable). Beginning or changing insulin was associated with a significant increase in HRQoL score (+15.0 points and +11.1 points, respectively), resulting in a similar score at 24 weeks in the two populations (77.8 and 75.9 points). Reported HRQoL also increased statistically significantly in people administering any insulin analogue regimen and across all regions, although there were some marked regional differences in reported HRQoL at baseline. CONCLUSION Compared with baseline scores, beginning insulin with, or switching to, insulin analogue therapies are associated with increased HRQoL.
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Affiliation(s)
- Siddharth Shah
- Bhatia Hospital, Bombay Mutual Terrace, 534 Sandhurst Bridge, 3rd Floor, Mumbai 400007, India.
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