Medium-term to long-term effect of digital self-management interventions for type 2 diabetes mellitus: protocol of a systematic review.

Abstract

Type 2 diabetes mellitus (T2DM) affects hundreds of millions of people worldwide. Self-management education is a cornerstone of diabetes care. Digital technology-based interventions have demonstrated short-term benefits; however, their medium-term to long-term effects remain unclear. We will systematically search seven databases (PubMed, Embase, the Cochrane Library, the China National Knowledge Infrastructure [CNKI], the China Biomedical Literature Database [CBM], Wanfang and the China Science Journal Database [VIP]) and three clinical trial registries (ClinicalTrials.gov, Chinese Clinical Trial Registry [ChiCTR] and WHO International Clinical Trials Registry Platform [ICTRP]) from inception to March 2026. We will include randomised controlled trials that provide diabetes self-management education via digital technologies, such as mobile applications, websites, text messaging, remote monitoring or computer programmes. Interventions may be fully digital or hybrid, provided that digital technology is the core delivery method. Eligible studies will involve adults with T2DM or studies in which at least 80% of the participants have T2DM, with a minimum follow-up of 12 months. Primary outcomes will be mortality, diabetes-related complications, hospitalisations, severe hypoglycaemia, quality of life and glycated haemoglobin. Secondary outcomes include fasting plasma glucose, lipids, blood pressure, anthropometric measures and patient-reported outcomes such as self-management behaviours and diabetes distress. Two reviewers will independently screen studies, extract data and assess the risk of bias using the Cochrane Risk of Bias 2 (RoB 2) tool. Where data are sufficient and studies are adequately comparable in terms of participants, interventions, comparators, outcomes and study design, we will perform meta-analyses using Cochrane Review Manager (RevMan) V.5.3 and Stata V.19.0. Heterogeneity will be explored through subgroup analyses and meta-regression. The certainty of evidence will be assessed using the Grading of Recommendations Assessment, Development and Evaluation approach. As this study will synthesise the published data, ethical approval is not required. CRD420251135023.