Although some evidence shows the beneficial effects of meal replacement (MR) on blood pressure (BP) and inflammation as one of the main factors of cardiovascular disease, there are still no comprehensive findings in this field. Therefore, we investigate the effects of total and partial MRs on BP and C-reactive protein (CRP) in this comprehensive study and meta-analysis. In order to identify all randomized controlled trials that investigated the effects of MRs on BP and CRP levels, a systematic search was conducted in the original databases using predefined keywords. The pooled weighted mean difference (WMD) and 95% confidence intervals (CIs) were computed using the random-effects model. Forty studies were included in this article. The findings indicated significant reductions in systolic blood pressure (SBP) (WMD, -2.51 mmHg; 95% CI, -3.48 to -1.54; P < 0.001), diastolic blood pressure (DBP) (WMD, -1.43 mmHg; 95% CI, -2.02 to -0.85; P < 0.001), and CRP (WMD, -0.50 mg/L; 95% CI, -0.89 to -0.11; P = 0.012) levels following MR consumption compared to the control group. The findings obtained from the subgroup analysis showed that MRs cause a greater reduction in SBP in people over 50 years of age, and the duration of the intervention ≤ 24 weeks. Also, the subgroup analysis shows the greater effect of DBP and CRP, respectively, in the type of intervention with total meal replacement and less equal to 50 years. In conclusion, it appears that MR, along with other lifestyle factors, can lead to significant improvements in BP and CRP.

The prevalence of obesity has increased significantly in recent years and is a causal risk factor for the development of type 2 diabetes. Moreover, chronic degenerative joint diseases are also triggered by obesity.

Both obesity-related secondary diseases-type 2 diabetes and chronic degenerative joint disease-can be prevented or at least delayed by lifestyle intervention aimed at weight reduction. The progression of these diseases can also be favourably influenced by radical weight loss. Diets with a reduction in carbohydrates-a so-called "low-carb" or ketogenic diet-appear to be superior to a low-fat diet.

If joint replacement surgery is necessary, preoperative and perioperative interdisciplinary care by a team of experienced therapists from the fields of orthopaedics and obesity/type 2 diabetes is required. The Düsseldorf TeDia model in the network of Catholic hospitals in Düsseldorf takes these requirements into account by providing interdisciplinary care for such patients at the orthopaedic centre at St. Vinzenz Hospital Düsseldorf and the West German Diabetes and Health Centre (WDGZ). Patients with pronounced obesity or diabetes mellitus are presented preoperatively at the WDGZ on an outpatient basis, and weight reduction therapy or optimization of the diabetic metabolic situation is initiated. If joint problems persist despite weight reduction or pronounced degenerative changes that require surgery, the WDGZ provides inpatient diabetology care in the orthopaedic clinic with the option of further outpatient follow-up care.

Background: Establishing a healthy lifestyle has a great potential to reduce the prevalence of non-communicable diseases (NCDs) and their risk factors. NCDs contribute immensely to the economic costs of the health care system arising from therapy, medication use, and productivity loss. Aim: The aim of this study was to evaluate the effect of the Healthy Lifestyle Community Program (cohort 2; HLCP-2) on medication use and consequently on medication costs for selected NCDs (diabetes, hypertension, and dyslipidemia). Methods: Data stem from a 24-month non-randomised, controlled intervention trial aiming to improve risk factors for NCDs. Participants completed questionnaires at six measurement time points assessing medication use, from which costs were calculated. The following medication groups were included in the analysis as NCD medication: glucose-lowering medications (GLM), antihypertensive drugs (AHD) and lipid-lowering drugs (LLD). Statistical tests for inter- and intra-group comparison and multiple regression analysis were performed. Results: In total, 118 participants (intervention group [IG]: n = 79; control group [CG]: n = 39) were considered. Compared to baseline medication use decreased slightly in the IG and increased in the CG. Costs for NCD medication were significantly lower in the IG than in the CG after 6 (p = 0.004), 12 (p = 0.040), 18 (p = 0.003) and 24 months (p = 0.008). After multiple regression analysis and adjusting for confounders, change of costs differed significantly between the groups in all final models. Conclusion: The HLCP-2 was able to moderately prevent an increase of medication use and thus reduce costs for medication to treat NCDs with the greatest impact on AHD.Trial registrationGerman Clinical Trials Register DRKS (www.drks.de; reference: DRKS00018775).

The global prevalence of obesity and overweight is a significant concern in the field of public health. Numerous interventional studies have been conducted to assess the possible meal replacements (MRs) effect on anthropometric indicators and indices and laboratory test that reflect obesity. However, there are no comprehensive results in this field. The study aim was to understand the possible effects of MRs on body weight, body mass index (BMI), fat mass, waist circumferences (WC), and leptin levels. A systematic search was conducted in five electronic databases in order to find randomized clinical trials (RCTs) that examined the possible MRs effect on obesity. Analyses were performed in R software, version 4.2.1. The random-effects model analysis was used to provide pooled mean difference and 95% confidence intervals (95% CI). Seventy studies were included. Body weight (WMD: -3.35 kg, 95% CI: -4.28 to -2.42), BMI (WMD: -1.12 kg/m2, 95% CI: -1.51 to -0.72), fat mass (WMD: -2.77 kg, 95% CI: -3.59 to -1.6), WC (WMD: -2.82 cm, 95% CI: -3.51 to -2.12) were significantly reduced after MRs compared to control. No significant effect was observed on leptin (WMD: -3.37 ng/ml, 95% CI: -8.23 to 1.49). Subgroup analyses indicated that impact of total MRs on anthropometric factors was greater in comparison to partial MRs. Considering other lifestyle factors, MRs can lead to anthropometric indicators and indices reduction.

This systematic review and meta-analysis included randomized controlled trials or observational studies that compare digital health interventions (DHIs) for telemedicine/telehealth versus usual care for managing blood pressure (BP) in adults. We searched PubMed, Cochrane CENTRAL, and IchuShi-Web, and used a random-effects meta-analysis of the weighted mean difference (MD) between the comparison groups to pool data from the included studies. The outcome included the pooled MD of office BP from baseline to each follow-up period. This meta-analysis considered 117 studies with 68677 participants as eligible. The 3-month intervention period reduced office systolic BP (SBP) compared with usual care in 38 studies (MD: -3.21 mmHg [95% confidence interval: -4.51 to -1.90]), with evidence of heterogeneity. Office SBP across intervention periods demonstrated comparable effects (3-, 6- [54 studies], 12- [43 studies], and >12-month periods [9 studies]). The benefits for office diastolic BP were similar to those for office SBP. Additionally, the interventions significantly reduced the office SBP compared with the control, regardless of the mode of intervention delivery (smartphone apps [38 studies], text messages [35 studies], and websites [34 studies]) or type of facility (medical [74 studies] vs. non-medical [33 studies]). The interventions were more effective in 41 hypertension cohorts compared with 66 non-hypertension cohorts (-4.81 mmHg [-6.33, -3.29] vs. -2.17 mmHg [-3.15, -1.19], P = 0.006 for heterogeneity). In conclusion, DHIs for telemedicine/telehealth improved BP management compared with usual care. The effectiveness with heterogeneity should be considered, as prudent for implementing evidence-based medicine. This meta-analysis considered 117 studies with 68677 participants eligible. The DHIs for telemedicine/telehealth reduced office BP compared with usual care, regardless of intervention duration, intervention delivery mode, facility type, and cohort type. Additionally, the DHIs reduced the risk of uncontrolled BP compared with usual care, regardless of intervention duration, intervention delivery mode, and facility type. BP blood pressure, DHI digital health intervention, MD mean difference, RR risk ratio, SBP systolic blood pressure.

Self-efficacy and self-management are fundamental factors for successful treatment of type 2 diabetes, but long-term studies are rare. The aim of the present study is to investigate whether the effects achieved in the context of a lifestyle intervention based on the transtheoretical model can be maintained by the patients in the long term.

A two-arm randomised controlled trial examined whether long-term effects of self-efficacy, self-management, and HbA1c can be achieved by a lifestyle intervention of 12 months and persisted beyond the intervention. During the intervention, the intervention group (n = 86, mean age 59.7 years) was supported by a telephone coach and telemedical devices, while the control group (n = 65, mean age 58.8 years) received regular care. In the year after intervention, both groups received standard care.

The intervention group achieved significantly better self-management after 12 and 24 months (12M, 1.11 (0.81; 1.41) p < .000; 24M, 0.52 (0.19; 0.85) p = .002) as well as self-efficacy (12M, 1.18 (0.83; 1.52) p < .000; 24M, 0.76 (0.39; 1.13) p < .000) and HbA1c than the control group.

TTM-based lifestyle interventions show a long-term effect beyond the duration of the intervention in most areas, and behavioural changes can be sustained by patients.

Telemedicine, propelled by recent technological advancements, has transformed healthcare delivery, notably benefiting patients with chronic non-communicable diseases (NCDs) such as systemic arterial hypertension and diabetes mellitus. This meta-analysis of randomized clinical trials aimed to assess the efficacy of telehealth-based interventions on disease control rates and clinical parameters among NCD patients, including systolic and diastolic blood pressure (SBP and DBP), fasting blood glucose (FBG), and glycated hemoglobin (HbA1c) levels.

We conducted searches in PubMed, Scopus, Web of Science, and the Cochrane Database for interventional studies that compared tele-monitoring with usual care in patients with hypertension and type 2 diabetes mellitus. Odds ratios with 95% confidence intervals (CIs) were computed.

Our meta-analysis included 75 studies, encompassing a total of 106,261 patients, with 50,074 (47.12%) receiving usual care and 56,187 (52.88%) receiving tele-monitoring care. The telemedicine group was associated with a statistically significant reduction in SBP (mean difference (MD) -4.927 mmHg; 95% CI -6.193 to -3.660; p < 0.001; I² = 90%), DBP (MD -2.019 mmHg; 95% CI -2.679 to -1.359; p < 0.001; I² = 54%), FBG (MD -0.405 mmol/L; 95% CI -0.597 to -0.213; p < 0.001; I² = 32%), and HbA1c (MD -0.418%; 95% CI -0.525 to -0.312; p < 0.001; I² = 76%).

Our meta-analysis shows that telehealth technologies notably enhance blood pressure and blood glucose control. This supports integrating telemedicine into clinical protocols as a valuable complementary tool for managing hypertension and diabetes mellitus comprehensively.

Background: While a positive correlation between age and HbA1c has been suggested in non-diabetic individuals, warranting higher HbA1c reference ranges for older adults, evidence among individuals with diabetes is less clear and may reveal an inverse trend. This study aimed to examine the relationship between age and HbA1c in a diabetic population, considering red cell parameters and other confounding factors; Methods: This cross-sectional study included 268 diabetic participants from Mongolia-Japan University Hospital (mean age 57.0 ± 9.9 years, 38.8% male, median diabetes duration 8.0 years, mean HbA1c 9.2 ± 3.3%). We analyzed the association between age and HbA1c using linear regression models, adjusting for diabetic characteristics, chronic complications, inflammation markers, and red cell indices. Subgroup analyses were conducted based on red cell distribution width (RDW) median splits; Results: A significant negative association between age and HbA1c was observed, with an unstandardized B coefficient (95% CI) of -0.112 (-0.166; -0.058, p < 0.001). This association persisted after adjustment for diabetic characteristics, complications, inflammation markers, and red cell indices (-0.115, -0.179; -0.051, p = 0.001). Subgroup analyses indicated a stronger negative association in participants with lower RDW levels (-0.174, -0.269; -0.079, p < 0.001) compared to those with higher RDW (-0.080, -0.147; -0.014, p = 0.019), suggesting that red cell characteristics may modify this relationship. No significant interactions were identified except for RDW; Conclusions: Our findings reveal a distinct negative association between age and HbA1c in diabetic individuals, independent of diabetic characteristics, complications, and inflammation markers. This association is particularly pronounced in individuals with lower RDW levels, highlighting the potential role of red cell morphology in influencing HbA1c levels with aging in diabetes.

Background: In recent years, the integration of mobile health (m-Health) interventions has garnered increasing attention as a potential means to improve blood pressure (BP) management in adults. This updated systematic review with meta-analysis aimed to identify the effect of m-Health-based interventions on BP in adults and to evaluate the effect of m-Health on BP according to the characteristics of subjects, interventions, and countries. Methods: The search was carried out in PubMed, Embase, ResearchGate, and Cochrane databases in January 2022. Study selection and data extraction were performed by two independent reviewers. For analysis, random effects models were used with a confidence interval (CI) of 95% and p < 0.05. Results: Fifty studies were included in this review and in the meta-analysis. Interventions with m-Health reduced systolic BP in 3.5 mmHg (95% CI -4.3; -2.7; p < 0.001; I2 = 85.8%) and diastolic BP in 1.8 mmHg (95% CI -2.3; -1.4; p < 0.001; I2 = 78.9%) compared to usual care. The effects of m-Health interventions on BP were more evident in men and in older adults, in interventions lasting 6-8 weeks, with medication reminders, with the possibility of insertion of BP values (p < 0.05). Conclusion: The results of this study support the effectiveness of m-Health in reducing BP when compared to standard care. However, these effects are dependent on the characteristics of the subjects and interventions. Given the substantial heterogeneity among the results of this systematic review with meta-analysis, its interpretation should be cautious. Future research on this topic is warranted.

Lifestyle interventions have garnered significant research interest for their potential to enhance health-related quality of life (HRQoL). Understanding the impact of these interventions on various dimensions of HRQoL is crucial for effective healthcare strategies. This study aims to systematically review and meta-analyze the effects of lifestyle interventions on HRQoL in randomized control trials. A systematic search was conducted across five scientific databases, including PubMed, Web of Science, Scopus, the Cochrane Library, and gray literature, with a filter applied to include only English language publications. Study selection was carried out by two independent reviewers in several steps, including duplicate removal and eligibility evaluation for meta-analysis. Information extracted from the studies included authors, countries, study designs, target populations, ages, genders, number of participants, interventions, outcomes, and results. A total of 61 randomized control trials were included in this meta-analysis. The meta-analysis revealed that lifestyle interventions significantly improved healthrelated quality of life compared to control groups, with Hedges' g of 0.38 (95% CI 0.25-0.50, Z = 5.94; P < 0.001; I2 = 84.59%). This positive effect was consistently observed in patients with heart-related diseases and metabolic disorders. Meta-regression analysis indicated that lifestyle interventions had the most substantial impact on health-related quality of life in the 1-month follow-up period. Considering the cost-effectiveness of lifestyle interventions compared to other intervention types, they can benefit various patient groups. This systematic review contributes to health policy goals by advocating focused preventive strategies in alignment with the observed benefits of lifestyle interventions.

The association of cardiovascular health levels, as measured by the Life's Essential 8 score, with cardiovascular disease (CVD) incidence and mortality among individuals with type 2 diabetes (T2D) has not been fully elucidated.

This cohort study included 15,118 participants with T2D from the UK Biobank who were free of CVD and cancer at baseline. The cardiovascular health of participants was evaluated using the Life's Essential 8 score, categorizing their health levels into low, moderate, and high based on this assessment.

During a median follow-up period of 13.0 years, we observed a total of 4421 cases of CVD, comprising 3467 cases of coronary heart disease (CHD), 811 cases of stroke, 1465 cases of heart failure (HF), and 523 cases of CVD mortality. Compared to participants with low cardiovascular health, those with high cardiovascular health had a 52 %, 50 %, 47 %, 67 %, and 51 % lower risk of CVD, CHD, stroke, HF, and CVD mortality, respectively. Among the components of the Life's Essential 8 score, body mass index showed the highest population attributable risk of 12.1 %. Similar findings were observed in joint analyses of cardiovascular health and diabetes severity status.

This study emphasizes the importance of maintaining good cardiovascular health among individuals with T2D to reduce their risk of CVD incidence and mortality.

Diabetes is considered one of the fastest growing diseases worldwide. Especially in the treatment of type 2 diabetes, lifestyle interventions have proven to be effective. However, long-term studies in real-world contexts are rare, which is why further research is needed. The aim of the present study is to investigate whether effects achieved in the context of a long-term lifestyle intervention can be sustained by patients in the long term.

In a two-arm randomized trial we compared diabetes care as usual to a lifestyle intervention combining telemedically support and individual needs-based telephone coaching. The study included 151 patients with type 2 diabetes randomized to either the intervention or control group. Intervention Group (IG; N = 86, 80.2% male, mean age: 59.7) received telemedical devices and telephone coaching over a period of 12 months, Control Group (CG; N = 65, 83.1% male, mean age: 58,8) received care as usual. The primary outcome was chance in HbA1c. A follow-up survey was conducted after 24 months.

The intervention group showed significantly better HbA1c- values compared to the control group at both 12 and 24 months (12 M: - 0.52 (-0.73; - 0.32), p < .000; 24 M: - 0.38 (-0.61; - 0.15), p = .001). The strongest change was seen in the first three months, with the best value obtained at 6 months and stable thereafter.

Combined telephone coaching with telemedicine support could lead to better long-term glycemic control in people with type 2 diabetes. In the future, more long-term studies should be conducted in real-world settings and lifestyle interventions should be offered more widely.

Therapeutic education and patient self-management are crucial in diabetes prevention and treatment. Improving diabetes self-management requires multidisciplinary team intervention, nutrition education that facilitates self-management, informed decision-making, and the organization and delivery of appropriate health care services. The emergence of telehealth services has provided the public with various tools for educating themselves and for evaluating, monitoring, and improving their health and nutrition-related behaviors. Combining health technologies with clinical expertise, social support, and health professional involvement could help persons living with diabetes improve their disease self-management skills and prevent its long-term consequences.

This scoping review's primary objective was to identify the key digital tool features of complex telehealth interventions used for type 2 diabetes or prediabetes self-management and monitoring with health professional involvement that help improve health outcomes. A secondary objective was to identify how these key features are developed and combined.

A 5-step scoping review methodology was used to map relevant literature published between January 1, 2010 and March 31, 2022. Electronic searches were performed in the MEDLINE, CINAHL, and Embase databases. The searches were limited to scientific publications in English and French that either described the conceptual development of a complex telehealth intervention that combined self-management and monitoring with health professional involvement or evaluated its effects on the therapeutic management of patients with type 2 diabetes or prediabetes. Three reviewers independently identified the articles and extracted the data.

The results of 42 studies on complex telehealth interventions combining diabetes self-management and monitoring with the involvement of at least 1 health professional were synthesized. The health professionals participating in these studies were physicians, dietitians, nurses, and psychologists. The digital tools involved were smartphone apps or web-based interfaces that could be used with medical devices. We classified the features of these technologies into eight categories, depending on the intervention objective: (1) monitoring of glycemia levels, (2) physical activity monitoring, (3) medication monitoring, (4) diet monitoring, (5) therapeutic education, (6) health professional support, (7) other health data monitoring, and (8) health care management. The patient-logged data revealed behavior patterns that should be modified to improve health outcomes. These technologies, used with health professional involvement, patient self-management, and therapeutic education, translate into better control of glycemia levels and the adoption of healthier lifestyles. Likewise, they seem to improve monitoring by health professionals and foster multidisciplinary collaboration through data sharing and the development of more concise automatically generated reports.

This scoping review synthesizes multiple studies that describe the development and evaluation of complex telehealth interventions used in combination with health professional support. It suggests that combining different digital tools that incorporate diabetes self-management and monitoring features with a health professional's advice and interaction results in more effective interventions and outcomes.

To collect health and wellness coaching (HWC) literature related to treatment of obesity and Type 2 Diabetes (T2D) for systematic assessment using a novel rubric.

Pubmed, CINAHL, and PsychInfo.

Given 282 articles retrieved, only randomized and controlled trials meeting a HWC criteria-based definition were included; studies with intervention <4 months or <4 sessions were excluded.

Rubric assessment required details of two theoretical frameworks (i.e., study design and HWC intervention design) be extracted from each included paper.

Data were derived from a 28-item rubric querying items such as sampling characteristics, statistical methods, coach characteristics, HWC strategy, and intervention fidelity.

29 articles were reviewed. Inter-rater rubric scoring yielded high intraclass correlation (r = .85). Rubric assessment of HWC literature resulted in moderate scores (56.7%), with study design scoring higher than intervention design; within intervention design, T2D studies scored higher than obesity.

A novel research design rubric is presented and successfully applied to assess HWC research related to treatment of obesity and T2D. Most studies reported beneficial clinical findings; however, rubric results revealed moderate scores for study and intervention design. Implications for future HWC research are discussed.

Health and Wellness Coaching (HWC) may be beneficial in chronic condition care. We sought to appraise its effectiveness on quality of life (QoL), self-efficacy (SE), depression, and anxiety.

We searched MEDLINE, EMBASE, CINAHL, PsycINFO, and Cochrane CENTRAL for randomized trials published January 2005 - March 2023 that compared HWC to standard clinical care or another intervention without coaching. We examined QoL, SE, depression, or anxiety outcomes. Meta-analysis utilizing the random-effects model was used to estimate the pooled standardized mean difference (SMD).

Thirty included studies demonstrated that HWC improved QoL within 3 months (SMD 0.62 95 % CI 0.22-1.02, p = 0.002), SE within 1.5 months (SMD 0.38, 95 % CI 0.03-0.73, p = 0.03), and depression at 3, 6, and 12 months (SMD 0.67, 95 % CI 0.13-1.20, p = 0.01), (SMD 0.72, 95 % CI 0.19-1.24, p = 0.006), and (SMD 0.41, 95 % CI 0.09-0.73, p = 0.01) Certainty in the evidence for most outcomes was either very low or low primarily due to the high risk of bias, heterogeneity, and imprecision.

HWC improves QoL, SE, and depression across chronic illness populations. Future research needs to standardize intervention reporting and outcome collection.

Future HWC studies should standardize intervention components, reporting, and outcome measures, apply relevant chronic illness theories, and aim to follow participants for greater than one year.

Nonalcoholic fatty liver disease (NAFLD) is a dynamic chronic liver disease that develops in close association with metabolic irregularities. Between 2016 and 2019, the global prevalence among adults was reported as 38% and among children and adolescents it was about 10%. NAFLD can be progressive and is associated with increased mortality from cardiovascular disease, extrahepatic cancers and liver complications. Despite these numerous adverse outcomes, no pharmacological treatments currently exist to treat nonalcoholic steatohepatitis, the progressive form of NAFLD. Therefore, the main treatment is the pursuit of a healthy lifestyle for both children and adults, which includes a diet rich in fruits, nuts, seeds, whole grains, fish and chicken and avoiding overconsumption of ultra-processed food, red meat, sugar-sweetened beverages and foods cooked at high heat. Physical activity at a level where one can talk but not sing is also recommended, including leisure-time activities and structured exercise. Avoidance of smoking and alcohol is also recommended. Policy-makers, community and school leaders need to work together to make their environments healthy by developing walkable and safe spaces with food stores stocked with culturally appropriate and healthy food items at affordable prices as well as providing age-appropriate and safe play areas in both schools and neighbourhoods.

Meal replacement (MR) is beneficial for the management of type 2 diabetes (T2D). However, MR prescription and patient characteristics vary substantially between studies using MR in T2D patients.

This work aimed to evaluate the efficacy and safety of MR in T2D patients by meta-analysis, with a focus on subgroup analysis of variable participant characteristics and MR prescription.

We searched PubMed, CENTRAL, Embase, Web of Science, and the clinical trial registration database up to March 2022. We included randomized controlled trials (RCTs) of 2 weeks or more assessing the effect and safety of MR in T2D patients in comparison with conventional diabetic diets (CDs).

A total of 17 RCTs involving 2112 participants were ultimately included. Compared with CDs, MR significantly reduced glycated hemoglobin A1c (HbA1c) (MD -0.46%; P < .001), fasting blood glucose (FBG, -0.62 mmol/L; P < .001), body weight (-2.43 kg; P < .001), and body mass index (BMI, -0.65; P < .001), and improved other cardiometabolic risk factors. In subgroup analyses, total MR showed greater improvement in HbA1c (-0.72% vs -0.32%; P = .01), FBG (-1.45 vs -0.56 mmol/L; P = .02), body weight (-6.57 vs -1.58 kg; P < .001), and BMI (-2.78 vs -0.37; P < .001) than partial MR. MR with caloric restriction showed more reduction in body weight (-3.20 vs -0.75 kg; P < .001) and BMI (-0.84 vs -0.24; P = .003) compared with those without caloric restriction. MR showed similar benefits in studies that included patients using insulin and those that did not. Both partial and total MR were well tolerated.

Compared with CDs, the MR-based dietary pattern further improved the glycemic control and adipose indicators in T2D patients. Appropriate calorie restriction and total MR might be more beneficial, while both patients treated with or without insulin treatment could similarly benefit from MR usage.

The effectiveness of the multimodal Telemedical Lifestyle Intervention Program (TeLIPro) was proven in the advanced stages of type 2 diabetes mellitus (T2DM). Since its therapeutic potential focusing on telemedical coaching without using a formula diet is unknown, we evaluated improvements in HbA1c, HbA1c normalisation rate, cardiometabolic risk factors, quality-of-life, and eating behaviour in real life. In this randomized-controlled trial, AOK Rhineland/Hamburg insured T2DM patients (n = 1163) were randomized (1:1) into two parallel groups, and 817 received the allocated intervention. In addition to routine care, all participants got scales, step counters, and access to an online portal. The TeLIPro group additionally received equipment for self-monitoring of blood glucose and telemedical coaching. Data were collected at baseline, after 6 and 12 months of intervention as well as after a 6-month follow-up. The primary endpoint after 12 months was (i) the estimated treatment difference (ETD) in HbA1c change and (ii) the HbA1c normalisation rate in those with diabetes duration < 5 years. The TeLIPro group demonstrated significantly stronger improvements in HbA1c (ETD -0.4% (-0.5; -0.2); p < 0.001), body weight, body-mass-index, quality-of-life, and eating behaviour, especially in T2DM patients with diabetes duration ≥ 5 years (ETD -0.5% (-0.7; -0.3); p < 0.001). The HbA1c normalisation rate did not significantly differ between groups (25% vs. 18%). Continuous addition of TeLIPro to routine care is effective in improving HbA1c and health-related lifestyle in T2DM patients with longer diabetes duration in real life.

Background The association of a healthy lifestyle with the prognosis of type 2 diabetes remains uncertain. We aimed to evaluate the associations of a healthy lifestyle and a higher American Heart Association's Life's Essential 8 score with incident macrovascular and microvascular diseases in type 2 diabetes. Methods and Results A total of 13 543 participants with baseline type 2 diabetes and free of macrovascular and microvascular diseases from the UK Biobank were included. A healthy lifestyle was determined based on body mass index, smoking, alcohol consumption, physical activity, sleep duration, and diet. Life's Essential 8 scores were generated from 8 metrics according to the American Heart Association's cardiovascular health advisory, ranging from 0 to 100. During a median follow-up of 12.1 years, 3279 (24.2%) incident macrovascular diseases and 2557 (18.9%) microvascular diseases were documented. Compared with those with a poor lifestyle, participants with an ideal lifestyle had significantly lower risks of incident macrovascular disease (hazard ratio [HR], 0.46 [95% CI, 0.36-0.59]) and microvascular disease (HR, 0.60 [95% CI, 0.47-0.77]). Significantly lower risks of macrovascular disease (HR, 0.20 [95% CI, 0.05-0.79]) and microvascular disease (HR, 0.24 [95% CI, 0.06-0.98]) were also found in the high cardiovascular health group (Life's Essential 8 scores: 80-100), compared to the low cardiovascular health group (scores: 0-49). Adhering to an ideal lifestyle may prevent 37.0% of macrovascular disease and 24.7% of microvascular disease, and attaining a high cardiovascular health may prevent 71.9% of macrovascular disease and 67.5% of microvascular disease. Conclusions A healthy lifestyle and a higher Life's Essential 8 score were associated with lower risks of macrovascular and microvascular diseases among participants with type 2 diabetes.

Self-management of Type 2 diabetes mellitus (T2D) is challenging. Regular self-monitoring of blood glucose and healthy lifestyles are required to improve glycometabolic control, thus delaying diabetes complications, and reducing hospitalizations. Digital technologies can empower patients in their disease management promoting self-management and motivation to change behaviors. We report the results of an exploratory trial aimed at evaluating the metabolic outcomes of using digital solutions for T2D self-management developed in the ProEmpower project, a European Commission funded Pre-Commercial Procurement.

Two digital solutions, DM4All and DiaWatch, which were codesigned with providers, patients, and caregivers, enabled the collection of clinical parameters by the patient using a smartphone integrated with the medical devices (glucometer, sphygmomanometer, scale, smart watch for heart rate monitoring and step counter). Data were automatically sent to the shared care plan allowing professionals to monitor adherence to treatment, set goals, and communicate more effectively with patients. At baseline and after an average follow-up of 8 months, glycosylated hemoglobin (HbA1c), body weight, blood pressure, and blood lipids were measured in 100 T2D patients using the ProEmpower solutions across different diabetes centers in Campania Region, age 45-79  years, both genders, and compared with a Control cohort of T2D patients (n = 100) with similar clinical characteristics and followed for a comparable period of observation in the same centers.

At baseline, the ProEmpower participants and the Control subjects were on average overweight, with a similar BMI in the two cohorts, and mean HbA1c was at acceptable levels (around 7.0%). After the 8 month exploratory trial, body weight, HbA1c, systolic and diastolic blood pressure, and plasma and LDL-cholesterol significantly decreased in the ProEmpower participants compared to baseline (p < 0.05 for all). The changes in systolic and diastolic blood pressure, and plasma and LDL-cholesterol were significantly different from those observed in the Control cohort (p < 0.05 for all).

This pilot study showed positive effects on metabolic outcomes relevant to cardiovascular risk in T2D of adopting digital telemedicine self-monitoring solutions based on automation of measurements and coaching on healthy lifestyles promotion.

There is a large body of evidence evaluating quality improvement (QI) programmes to improve care for adults living with diabetes. These programmes are often comprised of multiple QI strategies, which may be implemented in various combinations. Decision-makers planning to implement or evaluate a new QI programme, or both, need reliable evidence on the relative effectiveness of different QI strategies (individually and in combination) for different patient populations.

To update existing systematic reviews of diabetes QI programmes and apply novel meta-analytical techniques to estimate the effectiveness of QI strategies (individually and in combination) on diabetes quality of care.

We searched databases (CENTRAL, MEDLINE, Embase and CINAHL) and trials registers (ClinicalTrials.gov and WHO ICTRP) to 4 June 2019. We conducted a top-up search to 23 September 2021; we screened these search results and 42 studies meeting our eligibility criteria are available in the awaiting classification section.

We included randomised trials that assessed a QI programme to improve care in outpatient settings for people living with diabetes. QI programmes needed to evaluate at least one system- or provider-targeted QI strategy alone or in combination with a patient-targeted strategy. - System-targeted: case management (CM); team changes (TC); electronic patient registry (EPR); facilitated relay of clinical information (FR); continuous quality improvement (CQI). - Provider-targeted: audit and feedback (AF); clinician education (CE); clinician reminders (CR); financial incentives (FI). - Patient-targeted: patient education (PE); promotion of self-management (PSM); patient reminders (PR). Patient-targeted QI strategies needed to occur with a minimum of one provider or system-targeted strategy.

We dual-screened search results and abstracted data on study design, study population and QI strategies. We assessed the impact of the programmes on 13 measures of diabetes care, including: glycaemic control (e.g. mean glycated haemoglobin (HbA1c)); cardiovascular risk factor management (e.g. mean systolic blood pressure (SBP), low-density lipoprotein cholesterol (LDL-C), proportion of people living with diabetes that quit smoking or receiving cardiovascular medications); and screening/prevention of microvascular complications (e.g. proportion of patients receiving retinopathy or foot screening); and harms (e.g. proportion of patients experiencing adverse hypoglycaemia or hyperglycaemia). We modelled the association of each QI strategy with outcomes using a series of hierarchical multivariable meta-regression models in a Bayesian framework. The previous version of this review identified that different strategies were more or less effective depending on baseline levels of outcomes. To explore this further, we extended the main additive model for continuous outcomes (HbA1c, SBP and LDL-C) to include an interaction term between each strategy and average baseline risk for each study (baseline thresholds were based on a data-driven approach; we used the median of all baseline values reported in the trials). Based on model diagnostics, the baseline interaction models for HbA1c, SBP and LDL-C performed better than the main model and are therefore presented as the primary analyses for these outcomes. Based on the model results, we qualitatively ordered each QI strategy within three tiers (Top, Middle, Bottom) based on its magnitude of effect relative to the other QI strategies, where 'Top' indicates that the QI strategy was likely one of the most effective strategies for that specific outcome. Secondary analyses explored the sensitivity of results to choices in model specification and priors.  Additional information about the methods and results of the review are available as Appendices in an online repository. This review will be maintained as a living systematic review; we will update our syntheses as more data become available.

We identified 553 trials (428 patient-randomised and 125 cluster-randomised trials), including a total of 412,161 participants. Of the included studies, 66% involved people living with type 2 diabetes only. Participants were 50% female and the median age of participants was 58.4 years. The mean duration of follow-up was 12.5 months. HbA1c was the commonest reported outcome; screening outcomes and outcomes related to cardiovascular medications, smoking and harms were reported infrequently. The most frequently evaluated QI strategies across all study arms were PE, PSM and CM, while the least frequently evaluated QI strategies included AF, FI and CQI. Our confidence in the evidence is limited due to a lack of information on how studies were conducted.  Four QI strategies (CM, TC, PE, PSM) were consistently identified as 'Top' across the majority of outcomes. All QI strategies were ranked as 'Top' for at least one key outcome. The majority of effects of individual QI strategies were modest, but when used in combination could result in meaningful population-level improvements across the majority of outcomes. The median number of QI strategies in multicomponent QI programmes was three.  Combinations of the three most effective QI strategies were estimated to lead to the below effects:  - PR + PSM + CE: decrease in HbA1c by 0.41% (credibility interval (CrI) -0.61 to -0.22) when baseline HbA1c < 8.3%; - CM + PE + EPR: decrease in HbA1c by 0.62% (CrI -0.84 to -0.39) when baseline HbA1c > 8.3%;  - PE + TC + PSM: reduction in SBP by 2.14 mmHg (CrI -3.80 to -0.52) when baseline SBP < 136 mmHg; - CM + TC + PSM: reduction in SBP by 4.39 mmHg (CrI -6.20 to -2.56) when baseline SBP > 136 mmHg;  - TC + PE + CM: LDL-C lowering of 5.73 mg/dL (CrI -7.93 to -3.61) when baseline LDL < 107 mg/dL; - TC + CM + CR: LDL-C lowering by 5.52 mg/dL (CrI -9.24 to -1.89) when baseline LDL > 107 mg/dL. Assuming a baseline screening rate of 50%, the three most effective QI strategies were estimated to lead to an absolute improvement of 33% in retinopathy screening (PE + PR + TC) and 38% absolute increase in foot screening (PE + TC + Other).

There is a significant body of evidence about QI programmes to improve the management of diabetes. Multicomponent QI programmes for diabetes care (comprised of effective QI strategies) may achieve meaningful population-level improvements across the majority of outcomes. For health system decision-makers, the evidence summarised in this review can be used to identify strategies to include in QI programmes. For researchers, this synthesis identifies higher-priority QI strategies to examine in further research regarding how to optimise their evaluation and effects. We will maintain this as a living systematic review.

Previous systematic reviews have aimed to clarify the effect of telemedicine on diabetes. However, such reviews often have a narrow focus, which calls for a more comprehensive systematic review within the field. Hence, the objective of the present systematic review, meta-analysis, and meta-regression is to evaluate the effectiveness of telemedicine solutions versus any comparator without the use of telemedicine on diabetes-related outcomes among adult patients with type 2 diabetes (T2D).

This review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We considered telemedicine randomized controlled trials (RCT) including adults (≥18 years) diagnosed with T2D. Change in glycated hemoglobin (HbA1c, %) was the primary outcome. PubMed, EMBASE, and the Cochrane Library Central Register of Controlled Trials (CENTRAL) were searched on October 14, 2020. An overall treatment effect was estimated using a meta-analysis performed on the pool of included studies based on the mean difference (MD). The revised Cochrane risk-of-bias tool was applied and the certainty of evidence was graded using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach.

The final sample of papers included a total of 246, of which 168 had sufficient information to calculate the effect of HbA1c%. The results favored telemedicine, with an MD of -0.415% (95% confidence interval [CI] = -0.482% to -0.348%). The heterogeneity was great (I2 = 93.05%). A monitoring component gave rise to the higher effects of telemedicine.

In conclusion, telemedicine may serve as a valuable supplement to usual care for patients with T2D. The inclusion of a telemonitoring component seems to increase the effect of telemedicine.

We explored the dietary effects of replacing normal dietary staple foods with supplementary nutritional protein powder, dietary fiber, and fish oil on several metabolic parameters. We examined weight loss, glucose and lipid metabolism, and intestinal flora in obese individuals when compared with individuals on a reduced staple food low carbohydrate diet.

From inclusion and exclusion criteria, 99 participants (28 kg/m² ≤ body mass index (BMI) ≤ 35 kg/m²) were recruited and randomly assigned to control and intervention 1 and 2 groups. Physical examinations and biochemical indices were performed/gathered before the intervention and at 4 and 13 weeks post intervention. After 13 weeks, feces was collected and 16s rDNA sequenced.

After 13 weeks, when compared with controls, body weight, BMI, waist circumference, hip circumference, systolic blood pressure, and diastolic blood pressure values in intervention group 1 were significantly reduced. In intervention group 2, body weight, BMI, waist circumference, and hip circumference were significantly reduced. Triglyceride (TG) levels in both intervention groups were significantly reduced. Fasting blood glucose, glycosylated hemoglobin, glycosylated albumin, total cholesterol, and apolipoprotein B levels in intervention group 1 were decreased, while high density lipoprotein cholesterol (HDL-c) decreased slightly. Glycosylated albumin, TG, and total cholesterol levels in intervention group 2 decreased, while HDL-c decreased slightly, High sensitive C-reactive protein, MPO, Ox-LDL, LEP, TGF-β₁, IL-6, GPLD1, pro NT, GPC-4, and LPS levels in both intervention groups were lower when compared with controls. Adiponectin (ADPN) levels in intervention groups were higher when compared with controls. Tumor necrosis factor-α (TNF-α) levels in intervention group 1 were lower when compared with controls. There is no obvious difference in α diversity and β diversity between intestinal flora of 3 groups. Among the first 10 species of Phylum, only the control group and the intervention group 2 had significantly higher Patescibacteria than the intervention group 1. Among the first 10 species of Genus, only the number of Agathobacter in intervention group 2 was significantly higher than that in control group and intervention group 1.

We showed that an LCD, where nutritional protein powder replaced some staple foods and dietary fiber and fish oil were simultaneously supplemented, significantly reduced weight and improved carbohydrate and lipid metabolism in obese individuals when compared with an LCD which reduced staple food intake.

The impact on body weight development is usually analysed by comparing different diet types. Our approach was to change only one component, namely bread, common to most diets. In a single-centre triple-blind randomised controlled trial the effects of two different breads on body weight were analyzed without further lifestyle modification. Overweight adult volunteers (n = 80) were randomised 1:1 to exchange previously consumed breads for either a rye bread from milled whole grain (control) or a medium-carbohydrate, low-insulin-stimulating bread (intervention). Pre-tests demonstrated that the two bread types strongly differed in the glucose and insulin response elicited, but had similar energy content, texture and taste. The primary endpoint was the estimated treatment difference (ETD) in change of body weight after 3 months of treatment. Whereas body weight remained unchanged in the control group (-0.1 ± 2.0 kg), significant weight reduction was observed in the intervention group (-1.8 ± 2.9 kg), with an ETD of -1.7 ± 0.2 kg (p = 0.007), that was more pronounced in participants ≥ 55 years (-2.6 ± 3.3 kg), paralleled by significant reductions in body mass index and hip circumference. Moreover, in the intervention group, the percentage of participants with significant weight loss (≥1 kg) was twice as high as in the control group (p < 0.001). No other statistically significant changes in clinical or lifestyle parameters were noted. Simply exchanging a common insulinogenic bread for a low-insulin-stimulating bread demonstrates potential to induce weight loss in overweight persons, especially those at older age.

Digital health interventions such as smartphone applications (mHealth) or Internet resources (eHealth) are increasingly used to improve the management of chronic conditions, such as type 2 diabetes mellitus. These digital health interventions can augment or replace traditional health services and may be paid for using healthcare budgets. While the impact of digital health interventions for the management of type 2 diabetes on health outcomes has been reviewed extensively, less attention has been paid to their economic impact.

This study aims to critically review existing literature on the impact of digital health interventions for the management of type 2 diabetes on health and social care utilisation and costs.

Studies that assessed the impact on health and social care utilisation of digital health interventions for type 2 diabetes were included in the study. We restricted the digital health interventions to information provision, self-management and behaviour management. Four databases were searched (MEDLINE, EMBASE, PsycINFO and EconLit) for articles published between January 2010 and March 2021. The studies were analysed using a narrative synthesis approach. The risk of bias and reporting quality were appraised using the ROBINS-I checklist.

The review included 22 studies. Overall, studies reported mixed evidence on the impact of digital health interventions on health and social care utilisation and costs, and suggested this impact differs according to the healthcare utilisation component. For example, digital health intervention use was associated with lower medication use and fewer outpatient appointments, whereas evidence on general practitioner visits and inpatient admissions was mixed. Most reviewed studies focus on a single component of healthcare utilisation.

The review shows no clear evidence of an impact of digital health interventions on health and social care utilisation or costs. Further work is needed to assess the impact of digital health interventions across a broader range of care utilisation components and settings, including social and mental healthcare services.

The study protocol was registered on PROSPERO before searches began in April 2021 (registration number: CRD42020172621).

Behavioral programs are needed for prevention and treatment of NAFLD and the effectiveness of a web-based intervention (WBI) is similar to a standard group-based intervention (GBI) on liver disease biomarkers.

We aimed to test the long-term effectiveness of both programs on diabetes incidence, a common outcome in NAFLD progression.

546 NAFLD individuals (212 WBI, 334 GBI) were followed up to 60 months with regular 6- to 12-month hospital visits. The two cohorts differed in several socio-demographic and clinical data. In the course of the years, the average BMI similarly decreased in both cohorts, by 5% or more in 24.4% and by 10% or more in 16.5% of cases available at follow-up. After excluding 183 cases with diabetes at entry, diabetes was newly diagnosed in 48 cases during follow-up (31 (16.6% of cases without diabetes at entry) in the GBI cohort vs. 17 (9.7%) in WBI; p = 0.073). Time to diabetes was similar in the two cohorts (mean, 31 ± 18 months since enrollment). At multivariable regression analysis, incident diabetes was significantly associated with prediabetes (odds ratio (OR) 4.40; 95% confidence interval (CI) 1.97-9.81; p < 0.001), percent weight change (OR 0.57; 95% CI 0.41-0.79; p < 0.001) and higher education (OR 0.49; 95% CI 0.27-0.86; p = 0.014), with no effect of other baseline socio-demographic, behavioral and clinical data, and of the type of intervention. The importance of weight change on incident diabetes were confirmed in a sensitivity analysis limited to individuals who completed the follow-up.

In individuals with NAFLD, WBI is as effective as GBI on the pending long-term risk of diabetes, via similar results on weight change.

Given the high rates globally of Type 2 Diabetes Mellitus (T2DM), there is a clear need to target health behaviours through person-centred interventions. Health coaching is one strategy that has been widely recognised as a tool to foster positive behaviour change. However, it has been used inconsistently and has produced mixed results. This systematic review sought to explore the use of behaviour change techniques (BCTs) in health coaching interventions and identify which BCTs are linked with increased effectiveness in relation to HbA1C reductions.

In line with the PICO framework, the review focused on people with T2DM, who received health coaching and were compared with a usual care or active control group on HbA1c levels. Studies were systematically identified through different databases including Medline, Web of science, and PsycINFO searches for relevant randomised controlled trials (RCTs) in papers published between January 1950 and April 2022. The Cochrane collaboration tool was used to evaluate the quality of the studies. Included papers were screened on the reported use of BCTs based on the BCT taxonomy. The effect sizes obtained in included interventions were assessed by using Cohen's d and meta-analysis was used to estimate sample-weighted average effect sizes (Hedges' g).

Twenty RCTs with a total sample size of 3222 were identified. Random effects meta-analysis estimated a small-sized statistically significant effect of health coaching interventions on HbA1c reduction (g+ = 0.29, 95% CI: 0.18 to 0.40). A clinically significant HbA1c decrease of ≥5 mmol/mol was seen in eight studies. Twenty-three unique BCTs were identified in the reported interventions, with a mean of 4.5 (SD = 2.4) BCTs used in each study. Of these, Goal setting (behaviour) and Problem solving were the most frequently identified BCTs. The number of BCTs used was not related to intervention effectiveness. In addition, there was little evidence to link the use of specific BCTs to larger reductions in HbA1c across the studies included in the review; instead, the use of Credible source and Social reward in interventions were associated with smaller reductions in HbA1c.

A relatively small number of BCTs have been used in RCTs of health coaching interventions for T2DM. Inadequate, imprecise descriptions of interventions and the lack of theory were the main limitations of the studies included in this review. Moreover, other possible BCTs directly related to the theoretical underpinnings of health coaching were absent. It is recommended that key BCTs are identified at an early stage of intervention development, although further research is needed to examine the most effective BCTs to use in health coaching interventions.

https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021228567 .

The objective of this clinical practice guideline is to provide updated and new evidence-based recommendations for the comprehensive care of persons with diabetes mellitus to clinicians, diabetes-care teams, other health care professionals and stakeholders, and individuals with diabetes and their caregivers.

The American Association of Clinical Endocrinology selected a task force of medical experts and staff who updated and assessed clinical questions and recommendations from the prior 2015 version of this guideline and conducted literature searches for relevant scientific papers published from January 1, 2015, through May 15, 2022. Selected studies from results of literature searches composed the evidence base to update 2015 recommendations as well as to develop new recommendations based on review of clinical evidence, current practice, expertise, and consensus, according to established American Association of Clinical Endocrinology protocol for guideline development.

This guideline includes 170 updated and new evidence-based clinical practice recommendations for the comprehensive care of persons with diabetes. Recommendations are divided into four sections: (1) screening, diagnosis, glycemic targets, and glycemic monitoring; (2) comorbidities and complications, including obesity and management with lifestyle, nutrition, and bariatric surgery, hypertension, dyslipidemia, retinopathy, neuropathy, diabetic kidney disease, and cardiovascular disease; (3) management of prediabetes, type 2 diabetes with antihyperglycemic pharmacotherapy and glycemic targets, type 1 diabetes with insulin therapy, hypoglycemia, hospitalized persons, and women with diabetes in pregnancy; (4) education and new topics regarding diabetes and infertility, nutritional supplements, secondary diabetes, social determinants of health, and virtual care, as well as updated recommendations on cancer risk, nonpharmacologic components of pediatric care plans, depression, education and team approach, occupational risk, role of sleep medicine, and vaccinations in persons with diabetes.

This updated clinical practice guideline provides evidence-based recommendations to assist with person-centered, team-based clinical decision-making to improve the care of persons with diabetes mellitus.

Persistently poorly controlled type 2 diabetes (PPDM) is common and causes poor outcomes. Comprehensive telehealth interventions could help address PPDM, but effectiveness is uncertain, and barriers impede use in clinical practice.

To address evidence gaps preventing use of comprehensive telehealth for PPDM by comparing a practical, comprehensive telehealth intervention to a simpler telehealth approach.

This active-comparator, parallel-arm, randomized clinical trial was conducted in 2 Veterans Affairs health care systems. From December 2018 to January 2020, 1128 outpatients with PPDM were assessed for eligibility and 200 were randomized; PPDM was defined as maintenance of hemoglobin A1c (HbA1c) level of 8.5% or higher for 1 year or longer despite engagement with clinic-based primary care and/or diabetes specialty care. Data analyses were preformed between March 2021 and May 2022.

Each 12-month intervention was nurse-delivered and used only clinical staffing/resources. The comprehensive telehealth group (n = 101) received telemonitoring, self-management support, diet/activity support, medication management, and depression support. Patients assigned to the simpler intervention (n = 99) received telemonitoring and care coordination.

Primary (HbA1c) and secondary outcomes (diabetes distress, diabetes self-care, self-efficacy, body mass index, depression symptoms) were analyzed over 12 months using intent-to-treat linear mixed longitudinal models. Sensitivity analyses with multiple imputation and inclusion of clinical data examined the impact of missing HbA1c measurements. Adverse events and intervention costs were examined.

The population (n = 200) had a mean (SD) age of 57.8 (8.2) years; 45 (22.5%) were women, 144 (72.0%) were of Black race, and 11 (5.5%) were of Hispanic/Latinx ethnicity. From baseline to 12 months, HbA1c change was -1.59% (10.17% to 8.58%) in the comprehensive telehealth group and -0.98% (10.17% to 9.19%) in the telemonitoring/care coordination group, for an estimated mean difference of -0.61% (95% CI, -1.12% to -0.11%; P = .02). Sensitivity analyses showed similar results. At 12 months, patients receiving comprehensive telehealth had significantly greater improvements in diabetes distress, diabetes self-care, and self-efficacy; no differences in body mass index or depression were seen. Adverse events were similar between groups. Comprehensive telehealth cost an additional $1519 per patient per year to deliver.

This randomized clinical trial found that compared with telemonitoring/care coordination, comprehensive telehealth improved multiple outcomes in patients with PPDM at a reasonable additional cost. This study supports consideration of comprehensive telehealth implementation for PPDM in systems with appropriate infrastructure and may enhance the value of telehealth during the COVID-19 pandemic and beyond.

ClinicalTrials.gov Identifier: NCT03520413.

While obesity impairs health-related quality of life (HRQOL), lifestyle interventions targeting weight reduction have been effective in improving HRQOL. Therefore, we hypothesised that a meal replacement-based lifestyle intervention, which has been shown to successfully reduce weight, would also improve HRQOL more effectively than a lifestyle intervention alone. In the international, multicenter, randomised-controlled ACOORH-trial (Almased-Concept-against- Overweight-and-Obesity-and-Related-Health-Risk), overweight or obese participants with elevated risk for metabolic syndrome (n = 463) were randomised into two groups. Both groups received telemonitoring devices and nutritional advice. The intervention group additionally used a protein-rich, low-glycaemic meal replacement for 6 months. HRQOL was estimated at baseline, after 3 and 12 months, using the SF-36 questionnaire, and all datasets providing HRQOL data (n = 263) were included in this predefined subanalysis. Stronger improvements in the physical component summary (PCS) were observed in the intervention compared to the control group, peaking after 3 months (estimated treatment difference 2.7 [1.2; 4.2]; p < 0.0001), but also in the long-term. Multiple regression analysis demonstrated that insulin levels and the achieved weight loss were associated with the mental component summary (MCS) after 12 months (p < 0.05). Thus, meal replacement-based lifestyle intervention is not only effective in weight reduction but, concomitantly, in enhancing HRQOL.