EOI: Development of Devices and Drugs for Fully Automated Insulin Delivery at Meals

Organization: Breakthrough T1D
Apply By: 17 Sep 2024

About the Organization

Breakthrough T1D, founded in 1970, is a leading global type 1 diabetes (T1D) research and advocacy organization. As a tax-exempt nonprofit 501(c)3 organization, Breakthrough T1D is committed to improving everyday life for those diagnosed with T1D and driving innovation towards a cure. The organization connects top minds to advance treatments, influence policy, and improve access to care.

Purpose of the Proposal

Breakthrough T1D invites letters of intent (LOIs) to develop technologies for fully automated insulin delivery systems that require no manual input from users during meals. The ultimate goal is to create systems that can reduce the burden of living with T1D and improve glycemic outcomes by automating insulin delivery around meals.

Background

• Current Systems: Hybrid Closed Loop (HCL) systems are commercially available and improve glycemic outcomes but require manual management of insulin dosing around meals.
• Need for Improvement: Current HCL systems require user inputs, especially during meals, which limits quality-of-life improvements. Fully Closed Loop (FCL) systems that automate insulin delivery around meals could improve outcomes like HbA1c and time in range, particularly for those not currently achieving optimal glycemic outcomes.

Product Features

• No User Interactions: Systems should require no user inputs, not even simple meal announcements.
• Glycemic Management: Must manage mealtime glucose excursions while mitigating risks of hypoglycemia and hyperglycemia.
• Ease of Use: Should not impose additional burdens on users and ideally improve usability.
• Target Population: Systems should be designed for those not achieving recommended glycemic targets, not just highly engaged users.

Objectives

Breakthrough T1D seeks LOIs for the development of AID systems with the following focuses:

• Ultra-Rapid Insulin (URI): Preclinical and clinical development of URIs that are fast-on, fast-off, and integrate into AID systems.
• Adjunctive Therapies: Development of therapies that normalize prandial blood glucose excursions, eliminating the need for meal announcements.
• AID Algorithms: Development of algorithms that do not require meal announcements, with a focus on trial-ready systems.
• Combined Approaches: Integration of multiple approaches (e.g., URI, adjunctive therapy, algorithm) into a cohesive AID system.
• Clinical Trials: Trials focused on capturing user experience measures and recruiting a diverse population.

Critical Considerations

• Focus on Meals: Projects must address automated insulin delivery around meals, though systems addressing exercise and other glucose disturbances will be considered.
• User Experience: Trials should capture user experience endpoints where appropriate.
• Collaboration: Proposals from industry, and collaborative approaches between academia and industry, are strongly encouraged.
• Diversity in Recruitment: Clinical studies should recruit a population representative of the real world in terms of ethnicity, socioeconomic status, and other demographics.

Eligibility

• Who Can Apply: Domestic and foreign non-profit organizations, public and private institutions such as universities, colleges, hospitals, and government units. Applicants must hold relevant advanced degrees (e.g., M.D., Ph.D.) and have a faculty position or equivalent.
• Industry Participation: Applications from for-profit entities or collaborations between academia and industry are welcome, though additional information may be required for for-profit entities.
• Diversity Encouraged: Applications from persons with disabilities, women, and underrepresented minority groups in sciences are encouraged.

How to Apply

• Letter of Intent (LOI): Prospective applicants must submit an LOI online via Breakthrough T1D’s grants management system, RMS360. The LOI should follow the template provided and include:

  • Background/Rationale: Including preliminary data, references, and specific aims.
  • Technology Description: Explanation of how the proposed technology enables fully automated insulin delivery around meals.
  • Development Plan: Timeline for advancing the technology through pre-clinical and clinical development.
  • Ethical and Regulatory Plans: For clinical studies, including site selection and clinical operations.
  • Intellectual Property/Commercial Efforts: Including a list of existing business partnerships.
  • Estimated Budget: Total and yearly breakdown.

• Deadline: LOI must be submitted by Tuesday, September 17, 2024.

For more detailed information, please refer to the official RFA document.

For Regular Updates: Join the WhatsApp Group: WhatsApp Link