Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Dec 21, 2024
Open Peer Review Period: Dec 21, 2024 - Feb 15, 2025
Date Accepted: Apr 30, 2025
(closed for review but you can still tweet)
Impact of Digital Therapeutics for the Management of Adult Patients with Diabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
ABSTRACT
Background:
The increasing approval and application of digital therapeutic products in the management of chronic diseases, including diabetes, has raised questions about their effectiveness. This study conducted a systematic review and meta-analysis of research reporting on the effectiveness of digital therapeutic interventions in the management of diabetic patients.
Objective:
To report the effectiveness of digital therapeutic (DTx) interventions in the management of patients with type I diabetes, type II diabetes and prediabetes.
Methods:
Data sources included Web of Science, Medline, Embase, and the Cochrane Library. We included randomized controlled trials assessing the effectiveness of DTx interventions in the health management of individuals with prediabetes and those diagnosed with type 1 and type 2 diabetes. Our primary outcomes were HbA1c levels, FBG levels, BMI, and weight.
Results:
Nineteen studies were included in the meta-analysis (n=3264). The DTx intervention produced a noteworthy reduction in HbA1c levels among individuals with diabetes (-0.54%, 95% CI -0.72 to -0.36), as well as decreases in FBG levels (-0.56, 95% CI -0.76 to -0.37) and BMI (-0.84, 95% CI -1.23 to -0.45). Additionally, it contributed to the increases in LDL-C (-0.13, 95% CI -0.22 to -0.03) and triglyceride levels (-0.18, 95% CI -0.34 to -0.02). Subgroup analyses revealed a beneficial impact of DTx on improving HbA1c levels in patients with type 2 diabetes mellitus (MD -0.66, 95% CI -0.92 to -0.41). However, this intervention did not elicit a comparable improvement in HbA1c levels for patients with type 1 diabetes mellitus (MD -0.45, 95% CI -0.89 to -0.00). DTx did not significantly affect weight reduction (-1.07, 95% CI -2.33 to 0.20), systolic and diastolic blood pressure, total cholesterol levels, or high-density lipoprotein levels.
Conclusions:
The DTx intervention holds promise for enhancing health management among individuals with diabetes, potentially attenuating HbA1c levels, FBG levels, and BMI, especially in individuals with T2DM. Clinical Trial: We previously registered the review protocol at the PROSPERO database for systematic reviews (CRD42023473743).
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