The role of adaptive and innovative trial designs in diabetes research: A scoping review

<p dir="ltr">Background: Adaptive and master protocol clinical trials offer significant advantages for diabetes research, including enhanced efficiency and personalized treatment strategies. </p><p dir="ltr">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.</p><p dir="ltr">Data Sources: A systematic literature search was performed using MEDLINE, Embase, CENTRAL, Emcare, Global Health, Web of Science, and clinical trial registries. Grey literature searches complemented database findings. </p><p dir="ltr">Study Selection: Studies using adaptive, platform, basket, or umbrella trial designs in people with type 1 or type 2 diabetes were included.</p><p dir="ltr">Data Extraction: Data were charted using a standardized form. Extracted variables included diabetes type, trial design, adaptive features, interventions, endpoints, and key findings.</p><p dir="ltr">Data Synthesis: Of 396 articles screened, six published adaptive trials met inclusion criteria: three in type 1 diabetes, one in type 2 diabetes, and two in diabetes-related neuropathy. Most used adaptive features for dose-finding, response-adaptive randomisation and sample size re-estimation. 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.</p><p dir="ltr">Limitations: Despite a comprehensive search, some grey literature and unpublished studies may have been missed. Risk of bias was not assessed, consistent with scoping review methodology. </p><p dir="ltr">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. </p>