The Role of Adaptive and Innovative Trial Designs in Diabetes Research: A Scoping Review.

BACKGROUND: Adaptive and master protocol clinical trials offer significant advantages for diabetes research, including enhanced efficiency and personalized treatment strategies. PURPOSE: This scoping review aimed to systematically map the use of adaptive and master protocol designs in interventional trials for type 1 and type 2 diabetes, identify research gaps, and highlight opportunities for broader implementation. DATA SOURCES: A systematic literature search was performed using MEDLINE, Embase, CENTRAL, Emcare, Global Health, Web of Science, and clinical trial registries. Gray literature searches complemented database findings. STUDY SELECTION: Studies using adaptive, platform, basket, or umbrella trial designs in people with type 1 or type 2 diabetes were included. DATA EXTRACTION: Data were charted using a standardized form. Extracted variables included diabetes type, trial design, adaptive features, interventions, end points, and key findings. DATA SYNTHESIS: Of 396 articles screened, 6 published adaptive trials met the inclusion criteria: 3 in type 1 diabetes, 1 in type 2 diabetes, and 2 in diabetes-related neuropathy. Most used adaptive features for dose finding, response-adaptive randomization, and sample size reestimation. No published platform, basket, or umbrella trials were identified. Six ongoing adaptive trials in type 1 diabetes were identified through registry searches, four under an adaptive platform master protocol. LIMITATIONS: Despite a comprehensive search, some gray literature and unpublished studies may have been missed. Risk of bias was not assessed, consistent with scoping review methodology. CONCLUSIONS: Adaptive and master protocol trials remain rare in diabetes. Overcoming barriers through targeted training and awareness, robust regulatory frameworks, and strategic incentives could support broader adoption.