EOI - Development of devices and drugs for fully automated insulin delivery at meals

Organization:

Breakthrough T1D

• Founded: 1970
• Type: Nonprofit 501(c)3 organization
• Mission: Leading global type 1 diabetes research and advocacy to improve everyday life and drive toward cures.

Proposal Purpose:

• Objective: Develop technologies to allow fully automated insulin delivery at meals, reducing the need for manual input and improving glycemic outcomes.

Background:

• Current Systems: Hybrid Closed Loop (HCL) systems require manual insulin management around meals.
• Need: Fully Closed Loop (FCL) systems that automate meal-related insulin delivery can significantly reduce the burden on users and improve glycemic outcomes.
• Approaches:
  • Algorithms: For meal anticipation and insulin delivery.
  • Adjunctive Therapies: Such as insulin-pramlintide co-formulations.
  • Ultra-Rapid Insulin (URI): Fast-acting insulins to manage post-prandial glucose without meal announcements.

Product Features:

• No User Interaction: Systems should require no manual input, even for meal announcements.
• Glucose Management: Should effectively manage mealtime glucose while minimizing the risk of hypoglycemia and hyperglycemia.
• Usability: Should not impose additional burdens on users, and ideally improve current usability standards.

Objectives:

• Target Development: Academic and industry applicants are invited to submit LOIs to develop systems or components such as URIs, adjunctive therapies, or algorithms for fully automated insulin delivery.
• Priority Projects:
  • Preclinical and Clinical Development: Of URIs, adjunctive therapies, or algorithms for AID systems.
  • Trials: Focused on full automation of insulin delivery at mealtimes, with an emphasis on user experience.

Deliverables:

• Key Inflection Points: Projects should be designed with clear milestones, appropriate for their development stage, budget, and duration.

Critical Considerations:

• Automated Insulin Delivery Around Meals: Projects addressing this will be prioritized.
• Clinical Trials: Should include endpoints around user experience and recruit a diverse population.
• Collaborative Approaches: Encouraged, particularly between academic and industry partners.

Eligibility:

• Who Can Apply: Domestic and foreign non-profit organizations, universities, colleges, hospitals, and for-profit entities collaborating with academic institutions.
• Requirements: Applicants must hold relevant advanced degrees (e.g., M.D., Ph.D.) and have a faculty or equivalent position.

How to Apply:

• Letter of Intent (LOI): Must be submitted online using the LOI template provided in RMS360 by September 17, 2024.
• Full Proposal: Requires an approved LOI; details to be completed using templates provided on RMS360.

Key Dates:

• LOI Deadline: September 17, 2024

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

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