Automated insulin delivery in type 2 diabetes: a meta-analysis of randomized trials protocol

BACKGROUND: Type 2 diabetes mellitus (T2DM) is a highly prevalent chronic metabolic disorder, and a substantial proportion of patients eventually require insulin therapy, which is frequently complicated by therapeutic inertia, hypoglycemia and glycemic variability. Automated insulin delivery (AID) systems combine continuous glucose monitoring with algorithm-driven insulin delivery, but their efficacy and safety in adults with T2DM remain uncertain. The objective of this systematic review and meta-analysis is to evaluate the efficacy and safety of AID systems compared with conventional insulin-based strategies in adults with T2DM. METHODS: The conduct of this review will follow the Cochrane Handbook for Systematic Reviews of Interventions (version 6.5) and reporting will adhere to the PRISMA 2020 and PRISMA-P 2015 statements. Randomized controlled trials (parallel-group and cross-over) evaluating AID systems in adults with T2DM will be identified through a systematic search of MEDLINE (via PubMed), EMBASE, Scopus, the Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science from inception to 30 November 2025, without language restrictions. The strategy will combine controlled vocabulary, free-text terms, and the Cochrane Highly Sensitive Search Strategy for identifying RCTs; will be developed with input from an expert health-sciences librarian; and will be peer-reviewed using the PRESS 2015 checklist. Two reviewers will independently screen, extract data, and assess risk of bias using the Cochrane Risk of Bias 2 (RoB 2) tool. Pooled estimates will be calculated using random-effects inverse-variance meta-analysis; certainty of evidence will be rated with GRADE. DISCUSSION: This review will provide a comprehensive synthesis of randomized evidence on AID systems in T2DM and will inform clinicians, patients, guideline developers, and policymakers about the magnitude of benefit and the safety profile of this technology in routine practice. SYSTEMATIC REVIEW REGISTRATION: PROSPERO (CRD420261302666).