RFAs: Glycemic and Beta Cell Monitoring in Individuals at Risk of Type 1 Diabetes

JDRF is the world’s leading non-profit organization with the mission to improve the lives of people with T1D by accelerating breakthroughs for T1D. JDRF eagerly awaits the submission of pioneering research proposals aimed at advancing the understanding of glycemic changes during disease progression in presymptomatic individuals, with the potential to improve progression biomarkers and monitoring their transition to clinical diagnosis. The knowledge gained in this RFA may eventually be applicable to support regulatory decisions and be part of monitoring guidelines, enabling more effective early identification and timely intervention by healthcare professionals, including the use of innovative treatments like the recent FDA approved teplizumab treatment, as well as other immunotherapies currently in clinical trials. As such, its implementation would mark a significant milestone in the pursuit of delaying or preventing T1D and its associated complications.

Understanding how glycemic control and beta cell loss are interconnected during the presymptomatic phase is pivotal for advancing the knowledge of T1D. This research is not only essential for identifying individuals at high risk of clinical onset, but also for developing more effective management strategies that can enhance the lives of individuals at risk of developing clinical T1D.

Research Areas

• They encourage research proposals that address one or more of the following areas, but not limited to:
  • Longitudinal studies: Introducing an additional parameter to existing longitudinal studies with the goal of incorporating glycemic monitoring approaches such as CGMs or Cpeptide. This expansion aims to enhance the follow-up of current individuals enrolled, providing a more comprehensive understanding of measurements and contributing valuable insights to refine diabetes management strategies.
  • Retrospective studies: Conducting a retrospective analysis across longitudinal studies to deepen the understanding of historical data related to different glycemic monitoring approaches, including CGMs or C-peptide. This analysis aims to assess the effectiveness of these alternatives on identifying individuals at risk of disease progression and compare their reliability to traditional monitoring methods such as HbA1c and OGTT/MMT analysis.
  • Comparative studies between children and adults with clinical onset of T1D: Explore and compare data from longitudinal and interventional studies to understand the unique aspects of disease progression in pediatric populations versus adults. Additionally, they are keenly interested in adult monitoring follow-up from research studies, aiming to comprehensively assess and analyze the long-term outcomes and inform tailored strategies for the effective management of and interventions in this population.
  • Monitoring of immunotherapy treatments: Implementing follow-up glycemic monitoring for individuals undergoing disease modifying therapies, whether in FDA-approved treatments (e.g. teplizumab) or enrolled in other ongoing clinical trials. Establishing a robust system for continuous monitoring, allowing for better follow-up of patients and aiming to improve their outcomes through optimized glycemic management.
  • Clinical trials and the impact of glycemic monitoring approaches: Investigate the relationship between clinical outcomes and C-peptide data for use in clinical trial settings. This aspect aims to elucidate the potential value of C-peptide as a biomarker of disease progression in the context of clinical trials, contributing to the development of more effective and targeted monitoring approaches.
  • Advanced monitoring technologies: Develop and evaluate innovative monitoring technologies that provide real-time data on beta cell function and glucose control in presymptomatic individuals before and after they progress to clinical disease. The integration of cutting-edge monitoring devices with C-peptide assessment is critical for a comprehensive understanding of the disease progression.
  • Biomarker validation: Research projects focused on validating novel biomarkers of disease progression and beta cell loss (e.g. immune or beta cell biomarkers), while also evaluating their relationship with C-peptide levels and glycemic control. These biomarkers will be proven as indicators of disease progression before clinical diagnosis.
  • Ethnic and gender diversity and disparities: Investigate the impact of ethnicity on glucose management and C-peptide levels in T1D progression.

Funding Information

• Proposed budgets for projects should not exceed $900,000.00 total costs for up to 3 years of duration. The level of funding or duration will vary depending on the scope and overall objectives of the proposal. JDRF may consider applications with increased scope (time and/or budget) where there is a strong justification (e.g. clinical studies requiring additional funds to cover patient enrollment or payment of clinical sites).
• In response to this announcement, LOI’s can be submitted to JDRF through the following two mechanisms:
  • Strategic Research Agreements (SRA) are intended for support of research activities at non-for-profit entities such as academic institutions. SRA totals can include up to 10% indirect costs.
  • Industry Development and Discovery Program (IDDP) are intended for support of for-profit entities. They entail additional requirements and typically have a modest royalty payback to JDRF. If you want to submit an IDDP project, applicants must contact the JDRF scientific contact below before submitting their application. Indirect costs are not permitted on IDDP applications.

Eligibility Criteria

• Applications may be submitted by domestic and foreign non-for-profit organizations, public and private, such as universities, colleges, hospitals and laboratories, units of state and local governments, and eligible agencies of the federal government. Applicants must hold an M.D., D.M.D., D.V.M., Ph.D., or equivalent and have a faculty position or equivalent at a college, university, medical school, or other research facility.
• For-profit entities, or industry collaborations with academia, are welcomed to submit applications in response to this RFA. Please contact the JDRF scientific contact below prior to submitting the application. Additional information will be requested from for-profit entities if invited to submit a full proposal.
• For clinical studies, applicants must hold an appointment or joint appointment in a subspecialty of clinical medicine and conduct human clinical research.
• There are no citizenship requirements for this program. To assure continued excellence and diversity among applicants and awardees, JDRF welcomes applications from all qualified individuals and encourages applications from persons with disabilities, women, and members of minority groups underrepresented in the sciences.

For more information, visit JDRF.