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

Diabetes CarePublished Scoping review

Authors' conclusion

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.

Study context

Population
Interventional trials using adaptive, platform, basket or umbrella designs in people with T1D or T2D396 articles screened
Outcome
Use of adaptive and master protocol designs in T1D and T2D interventional trials
Methodological detailsRisk of bias not assessed, consistent with scoping review methodology
  • Risk of bias not assessed, consistent with scoping review methodology

Main finding

As reported in the abstract

Articles screened
396
Published adaptive trials meeting inclusion criteria
6
Published adaptive trials in T1D
3
Published adaptive trials in T2D
1
Published adaptive trials in diabetes-related neuropathy
2
Ongoing adaptive trials in T1D identified through registry searches
6
Ongoing T1D adaptive trials under an adaptive platform master protocol
4

Further findings

Ongoing adaptive trials in T1D (registry searches)

Ongoing adaptive trials in T1D
6
Under an adaptive platform master protocol
4

Original publication

The Role of Adaptive and Innovative Trial Designs in Diabetes Research: A Scoping Review. Diabetes Care. Published 20 November 2025. doi:10.2337/dc25-1508

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