Background: Digital technologies for type 2 diabetes mellitus (T2DM) care hold great potential to improve patients’ health in the long term. Only a subset of telemedicine offerings are digital interventions that meet the criteria for prescribable digitale Gesundheitsanwendung (digital health apps; DiGAs) in Germany. Digital treatments further provide vast amounts of patient data that are important to generate evidence. Objective: This systematic review aims to analyze the efficacy of multimodal digital therapies that mainly meet the DiGA criteria for patients with T2DM and to elicit the potential of such therapies. This includes evidence from randomized controlled trials (RCTs) as well as from real-world data. The outcome of interest was a reduction in glycated hemoglobin (hemoglobin A1c [HbA1c]; long-term blood glucose measurements). Methods: A systematic literature search was conducted in the literature bases PubMed, LIVIVO, and Cochrane, based on the predefined PICO (Population; Intervention; Control; Outcome) scheme. Identified studies were assessed for risk of bias, pragmatism, and overall quality of evidence. Meta-analyses were conducted for between group differences using RCTs only, and for within-group differences using RCTs and non-RCTs, to examine the effect of the interventions on HbA1c. Results: In total, 795 records were identified, of which 24 were eligible for this systematic review and 23 studies were eligible for the meta-analysis. The results of the meta-analyses showed significant and clinically relevant reductions in HbA1c in patients with T2DM. Regarding the between-group difference for HbA1c reduction, the pooled effect of the RCTs showed a reduction of –0.36% (95% CI –0.59% to –0.14%; P<.001), favoring app-based interventions. The average mean within-group reduction in HbA1c was –0.79 (95% CI –1.02 to –0.55), with no significant difference between RCTs (–0.69, 95% CI –1.13 to –0.24) and non-RCTs (–0.87, 95% CI –1.16 to –0.57; P<.01, differences between RCTs and RCTs P=.44). A pragmatism rating showed that both study types were on average (very) pragmatic, that is, close to usual care. However, the overall quality of evidence was low to very low. Conclusions: This systematic review shows that digital therapies that mainly meet the DiGA criteria can effectively improve HbA1c in patients with T2DM. The integration of digital health care into usual care holds great potential and should be considered as a complementary option to usual care in the future. Trial Registration: PROSPERO CRD42023440203; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=440203

Obesity is a risk factor in cardiovascular disease (CVD), and scalable treatment approaches are needed in routine care. The aim of this retrospective observational study was to investigate self-reported weight change during the use of a prescription digital therapy for multimodal lifestyle therapy for obesity. Adults with obesity and self-reported CVD risk factors (n = 4314) or self-reported established CVD (n = 1418) prescribed zanadio for up to 12 months were included. The primary outcome was percentage change in self-reported body weight over time. Clinically meaningful weight loss (≥5%) was observed in patients on continued prescriptions, with greater weight loss observed in patients with prolonged program exposure. The results were directionally consistent across analyses that used a randomly missing approach and a sensitivity analysis with the last observation forward, although estimates varied in magnitude. Interpretation of this data in a real-world setting is limited by self-reported weight and comorbidity data, attrition which is typical for weight loss programs in the reality of care, and uncertainty about the mechanism of missing data. These results suggest that zanadio may support clinically meaningful self-reported weight loss in patients continuing treatment, but further studies linking clinical data and with longer follow-up are needed.

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: Digital technologies for type 2 diabetes mellitus (T2DM) care hold great potential to improve patients’ health in the long term. Only a subset of telemedicine offerings are digital interventions that meet the criteria for prescribable digitale Gesundheitsanwendung (digital health apps; DiGAs) in Germany. Digital treatments further provide vast amounts of patient data that are important to generate evidence. Objective: This systematic review aims to analyze the efficacy of multimodal digital therapies that mainly meet the DiGA criteria for patients with T2DM and to elicit the potential of such therapies. This includes evidence from randomized controlled trials (RCTs) as well as from real-world data. The outcome of interest was a reduction in glycated hemoglobin (hemoglobin A_1c [HbA_1c]; long-term blood glucose measurements). Methods: A systematic literature search was conducted in the literature bases PubMed, LIVIVO, and Cochrane, based on the predefined PICO (Population; Intervention; Control; Outcome) scheme. Identified studies were assessed for risk of bias, pragmatism, and overall quality of evidence. Meta-analyses were conducted for between group differences using RCTs only, and for within-group differences using RCTs and non-RCTs, to examine the effect of the interventions on HbA_1c. Results: In total, 795 records were identified, of which 24 were eligible for this systematic review and 23 studies were eligible for the meta-analysis. The results of the meta-analyses showed significant and clinically relevant reductions in HbA_1c in patients with T2DM. Regarding the between-group difference for HbA_1c reduction, the pooled effect of the RCTs showed a reduction of –0.36% (95% CI –0.59% to –0.14%; P<.001), favoring app-based interventions. The average mean within-group reduction in HbA_1c was –0.79 (95% CI –1.02 to –0.55), with no significant difference between RCTs (–0.69, 95% CI –1.13 to –0.24) and non-RCTs (–0.87, 95% CI –1.16 to –0.57; P<.01, differences between RCTs and RCTs P=.44). A pragmatism rating showed that both study types were on average (very) pragmatic, that is, close to usual care. However, the overall quality of evidence was low to very low. Conclusions: This systematic review shows that digital therapies that mainly meet the DiGA criteria can effectively improve HbA_1c in patients with T2DM. The integration of digital health care into usual care holds great potential and should be considered as a complementary option to usual care in the future. Trial Registration: PROSPERO CRD42023440203; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=440203

Background: Healthcare systems face increasing demands in chronic disease management such as obesity. Mobile applications offer scalable tools for weight management, ranging from simple trackers to prescribable digital therapeutics. Objective: This review evaluates the effectiveness of fully remote, app‐based interventions using a multimodal approach for weight loss in adults with obesity. Complying with international guidelines, these interventions combine behavior change strategies for diet, physical activity, and/or psychosocial education. Methods: A systematic literature search was performed. Eligible studies were assessed using the Cochrane Risk of Bias Tool 2 and the Grading of Recommendations, Assessment, Development and Evaluation approach for certainty of evidence. A meta‐analysis was performed for body weight outcomes. Results: Twelve randomized controlled trials and five systematic reviews were included, reporting changes in body weight or body mass index. The standardized mean difference of body weight changes at the end of intervention was −0.50 (95% confidence interval: −0.77, −0.22), corresponding to a mean difference of −2.61 kg (−4.45, −0.78). Heterogeneity was substantial ( I ² = 79.2%; p < 0.0001). Conclusion: Fully remote, app‐based interventions show moderate weight loss with promising potential in obesity management. However, heterogeneity between studies highlights the need for further research into potential factors with a significant influence on the results.