Breakthrough T1D Request for Applications: Development of Continuous C-Peptide Monitoring Technologies

Funding over a maximum of three years for the pre-clinical development of technologies for continuous C-peptide monitoring (CCPM) for application in type 1 diabetes.

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) and its complications.

Breakthrough T1D has issued this Request for Applications – Development of Continuous C-Peptide Monitoring Technologies – to solicit proposals for the development of technologies for continuous C-peptide monitoring (CCPM), primarily through early-stage and preclinical studies, with potential application across the stages of T1D.

C-peptide is a by-product of endogenous insulin production and is widely recognised as a biomarker of beta cell function. Current monitoring methods for C-peptide – such as stimulated tests (eg glucagon stimulation) and point-of-care (POC) assays that assess basal levels without stimulation – are invasive, time-consuming, and limited to single time-point measurements in clinical settings.

Current testing strategies also do not account for the dynamic nature and variability of C-peptide secretion, which is influenced by food intake, physical activity, circadian rhythms, and other physiological factors. A single measurement may overestimate or underestimate true beta cell function depending on transient metabolic conditions.

To address these limitations, Breakthrough T1D is seeking proposals for the research and development of continuous C-peptide monitoring (CCPM) technologies to improve understanding of T1D progression and beta cell function over time and support the development and evaluation of disease-modifying and cell-based therapies.

CCPM would enable high-resolution, real-time assessment of beta cell activity and could distinguish between short-term fluctuations and sustained changes in secretion patterns, providing a more accurate and actionable picture of beta cell status. This capability could support earlier detection of functional recovery or deterioration, improve characterisation of therapeutic effects, and enhance clinical and research decision-making.

Accordingly, this RFA is seeking proposals from academic and industry applicants with innovative approaches to develop CCPM technologies. Proposals will primarily in the form of early-stage and preclinical studies, with potential application across the stages of T1D.

Breakthrough T1D is seeking to develop sensor platforms capable of detecting C-peptide at physiological concentrations with sufficient sensitivity, specificity, and stability for real-world, longitudinal use. While the primary focus is on continuous monitoring, proposals that enable high frequency or at-home testing will also be considered, provided they represent clear improvements over existing methods and support practical, scalable assessment of beta cell function.

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

• Early-stage development of sensor technologies capable of continuous or high-frequency C-peptide detection in biological fluids such as plasma or interstitial fluid.
• Preclinical development and validation of CCPM systems.
• Feasibility studies and early-stage clinical evaluation of CCPM technologies.

Depending on the context and maturity of the technology, CCPM platforms developed under this RFA may ultimately serve as:

• Improved tools for clinical care;
• Investigational tools to accelerate development of disease-modifying therapies; or
• Companion diagnostics to guide or monitor response to therapies such as immunotherapy or cell therapy.