TY  - JOUR
AU  - Bodner, Emma
AU  - Roth, Lena
AU  - Wiencke, Kathleen
AU  - Bischoff, Christian
AU  - Schwarz, Peter EH
PY  - 2025
DA  - 2025/1/24
TI  - Effect of Multimodal App-Based Interventions on Glycemic Control in Patients With Type 2 Diabetes: Systematic Review and Meta-Analysis
JO  - J Med Internet Res
SP  - e54324
VL  - 27
KW  - app-based interventions
KW  - diabetes mellitus type 2
KW  - digital health
KW  - real world evidence
KW  - pragmatic trials
KW  - ehealth
KW  - mhealth
KW  - HbA1c
KW  - systematic review
KW  - meta-analysis
KW  - interventions
KW  - app
KW  - glycemic
KW  - patients
KW  - type 2 diabetes
AB  - 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 
SN  - 1438-8871
UR  - https://www.jmir.org/2025/1/e54324
UR  - https://doi.org/10.2196/54324
DO  - 10.2196/54324
ID  - info:doi/10.2196/54324
ER  -