Breakthrough T1D Request for Applications: Studies Assessing the Clinical Meaningfulness of Insulin Dose in Type 1 Diabetes

Funding over a maximum of two years for studies that aim to explore and define the relationship between insulin dose, and insulin dose reductions, and T1D outcomes.

Breakthrough T1D, based in the United States, is an international organisation that funds innovative research in pursuit of its mission to advance the treatment, prevention and cure of type-1 diabetes (T1D).

Breakthrough T1D has issued this Request for Applications – Studies Assessing the Clinical Meaningfulness of Insulin Dose in Type 1 Diabetes – to solicit applications for studies, including data analyses and clinical trials, to explore and define the relationship between insulin dose, insulin dose reductions, and T1D outcomes.

People with T1D require lifelong insulin therapy to compensate for a partial or complete lack of endogenous insulin production, however it is generally thought that therapeutic approaches allowing for insulin dose to be reduced without compromising glucose and ketone control will be beneficial for people with T1D.

There are significant knowledge gaps of how insulin needs and dose influence outcomes in people with T1D. Accordingly, Breakthrough T1D is soliciting proposals for studies investigating the effects of insulin dose and insulin dose reduction on acute and long-term T1D outcomes, including analysis of sufficiently large data sets that include both reliable insulin dose information and relevant clinical outcomes, or mechanistic clinical trials.

Examples of research topics appropriate for this RFA include, but are not limited to:

• Analysis of data from sources (eg registries, completed clinical trials, electronic health records, medical claims, other) that allow for assessment of the relationship between insulin dose and relevant clinical outcomes.
• Retrospective cross-sectional, retrospective longitudinal, and prospective observational studies.
• Clinical trials to assess mechanistic hypotheses about the effects of insulin dose on relevant outcomes.

Examples of key deliverables include, but are not limited to:

• Assessment of the association between T1D outcomes and insulin dose, including with adjustment for HbA1c and other confounders.
• Identification of factors that mediate any effects of insulin dose on T1D outcomes.
• Determination of whether insulin dose improves prediction of T1D outcomes beyond established risk factors.
• Novel risk models for long-term complications that incorporate insulin dose.
• Mechanistic insights into whether and how insulin dose and changes in insulin dose affect T1D outcomes.
• Evidence that informs how insulin dose as a trial endpoint should be considered by clinicians, therapy developers, and regulators.