Commercial Automated Insulin Delivery Systems in Type 1 Diabetes Pregnancy: Protocol for a Mixed-Methods Systematic Review and Meta-Analysis of Glycaemic, Perinatal, Psychosocial and Implementation Outcomes.

BACKGROUND:Commercial automated insulin delivery (AID) systems are increasingly used in pregnancies complicated by Type 1 diabetes, but the evidence is dispersed across trials, observational studies, case series and qualitative research. Existing syntheses have largely emphasised glycaemic efficacy and selected perinatal outcomes, with less attention to device platform, timing of initiation, psychosocial burden, clinician workload and implementation context. AIMS:To describe the protocol for a mixed-methods systematic review and meta-analysis evaluating the effectiveness, safety, feasibility, acceptability and implementation of commercial AID systems in Type 1 diabetes pregnancy. METHODS:MEDLINE, Embase, CINAHL, Scopus, Emcare, the Cochrane Library, CENTRAL and ClinicalTrials.gov will be searched from 1 January 2010, with an update search before final synthesis. Eligible evidence will include randomised and non-randomised comparative studies, observational cohorts, case series, qualitative studies and mixed-methods studies involving pregnant women with Type 1 diabetes using commercial AID systems, including off-label pregnancy use. Two reviewers will independently screen, extract and appraise studies and inter-rater agreement will be reported. Randomised and non-randomised comparative evidence will be synthesised separately and, where studies are sufficiently comparable, meta-analysed within study-design and comparator strata. Quantitative outcomes will include pregnancy-specific time in range, other continuous glucose monitoring (CGM) metrics, maternal and neonatal outcomes, diabetes-specific adverse events, psychosocial measures, cost, resource use, feasibility, implementation and early postpartum outcomes. Qualitative evidence will be synthesised thematically and integrated with quantitative findings using a convergent segregated approach. DISCUSSION:The review will clarify what is known about commercial AID use in Type 1 diabetes pregnancy and identify patient-, device-, clinician- and service-level factors relevant to implementation. TRIAL REGISTRATION:This systematic review protocol is registered with PROSPERO: CRD420251025194.