Impact of Digital Therapeutics for the Management of Adult Patients With Diabetes: Systematic Review and Meta-Analysis of Randomized Controlled Trials (Preprint)

<sec> <title>BACKGROUND</title> The growing approval and use of digital therapeutics (DTx) for managing chronic diseases, such as diabetes, has prompted questions about their effectiveness. </sec> <sec> <title>OBJECTIVE</title> This systematic review and meta-analysis aimed to report the effectiveness of DTx interventions in the management of patients with type 1 diabetes, type 2 diabetes, and prediabetes. </sec> <sec> <title>METHODS</title> Data sources, including Web of Science, MEDLINE, Embase, and the Cochrane Library, were searched from inception to July 30, 2023. 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 diabetes and type 2 diabetes. Our primary outcomes were glycated hemoglobin (HbA&lt;sub&gt;1c&lt;/sub&gt;) levels, fasting blood glucose (FBG) levels, BMI, and weight. Trials that met the eligibility criteria were scored for risk of bias using the Cochrane Risk of Bias Tool 2.0. A narrative synthesis and meta-analysis of included studies were also conducted. </sec> <sec> <title>RESULTS</title> A total of 19 studies were included in the meta-analysis (n=3264). The DTx intervention produced a noteworthy reduction in HbA&lt;sub&gt;1c&lt;/sub&gt; levels among individuals with diabetes (weighted mean difference [WMD] −0.54%, 95% CI −0.72 to −0.36), as well as decreases in FBG levels (WMD −0.56, 95% CI −0.76 to −0.37) and BMI (WMD −0.84, 95% CI −1.23 to −0.45). In addition, it contributed to the increases in low-density lipoprotein cholesterol (WMD −0.13, 95% CI −0.22 to −0.03) and triglyceride levels (WMD −0.18, 95% CI −0.34 to −0.02). Subgroup analyses revealed a beneficial impact of DTx on improving HbA&lt;sub&gt;1c&lt;/sub&gt; levels in patients with type 2 diabetes mellitus (mean difference −0.66, 95% CI −0.92 to −0.41). However, this intervention did not elicit a comparable improvement in HbA&lt;sub&gt;1c&lt;/sub&gt; levels for patients with type 1 diabetes mellitus (mean difference −0.45, 95% CI −0.89 to −0.00). DTx did not significantly affect weight reduction (WMD −1.07, 95% CI −2.33 to 0.20), systolic and diastolic blood pressure, total cholesterol levels, or high-density lipoprotein levels. </sec> <sec> <title>CONCLUSIONS</title> The DTx intervention holds promise for enhancing health management among individuals with diabetes, potentially attenuating HbA&lt;sub&gt;1c&lt;/sub&gt; levels, FBG levels, and BMI, especially in individuals with type 2 diabetes. </sec> <sec> <title>CLINICALTRIAL</title> PROSPERO CRD42023473743; https://www.crd.york.ac.uk/PROSPERO/view/CRD42023473743 </sec>