RFAs: Development of Devices and Drugs for fully Automated Insulin Delivery at Meals

Breakthrough T1D is a longstanding supporter of automated insulin delivery (AID) systems. Today’s commercially available AID systems are hybrid closed loop (HCL), meaning they require manual management of insulin dosing around meals, exercise, and other events that cause significant changes to glucose levels. Fully closed loop (FCL) systems that automate insulin delivery with no need for manual input from the user can reduce the burden of living with T1D and achieve superior glycemic outcomes.

Objectives

• Letters of intent (LOIs) are sought from academic and industry applicants to develop AID systems with the features listed above, or to develop components of such systems (e.g. rapid-acting insulins) that will be incorporated into AID systems in the future.
• Examples of research appropriate for this RFA include, but are not limited to:
  • Preclinical development of URIs, either novel insulin analogs or existing analogs in novel formulations, designed to be “fast-on, fast-off”. While the ultimate goal must be incorporation into an AID system, Breakthrough T1D will consider supporting development efforts that must be completed first, such as pharmacokinetic studies in animal models outside the AID context. URIs in any stage of development are eligible for funding, but priority will be given to projects supporting insulins that have been validated in animal models.
  • Clinical development of URIs, including trials to investigate pharmacokinetics/pharmacodynamics and/or assess efficacy in an AID context without meal announcements.
  • Clinical development of adjunctive therapies that normalize prandial blood glucose excursions, alleviating the need for announcements of meals. Adjunctive therapies may be either co-formulated with insulin or stand-alone products, and may be designed for T1D or repurposed from other indications.
  • Clinical development of AID algorithms that forego the requirement for meal announcements. Only trial-ready algorithms with strong preliminary data (e.g., from simulations or previous clinical trials) will be considered for funding.
  • Clinical development of an AID system composed of more than one of the above approaches (URI, adjunctive therapy, algorithm).
  • Trials in populations most likely to clinically benefit from full mealtime automation of insulin delivery.
  • Trials of AID systems with full automation at mealtime focused on capturing measures of user experience in addition to blood glucose and other clinical endpoints.
  • Other innovative approaches aligned with the goal of developing AID systems with full automation around meals.
• Examples of research not covered by this RFA include:
  • Development of technologies that will enable improved HCL systems requiring meal announcements.
  • Decision support tools that require user input.
  • Development of systems to enable fully automated delivery of insulin only around exercise or other periods of rapid glycemic change, and not meals.
  • Development of glucose responsive insulins.
• Deliverables
  • Projects should be designed to achieve key inflection points appropriate to project duration, budget, and initial stage of development.

Funding Information  

• Applications proposing clinical trials may request up to a total of $2,000,000 over a maximum of three years; applications proposing nonclinical work may request up to $1,000,000 over a maximum of two years.

Product Features

• This RFA is intended to support the development of AID systems, or components of an AID system, with the following features:
  • No user interactions, even simple meal announcements, required for adequate coverage of typical meals and snacks
  • AID systems must manage mealtime glucose excursions while mitigating the risk of delayed hypoglycemia and hyperglycemia
  • The system must not impose additional burdens on users (for example, additional external wearables), and would ideally improve upon current levels of usability.
  • AID systems developed for a target population that includes people not currently achieving recommended glycemic targets, rather than just the most highly engaged users already achieving optimal glucose outcomes, will be prioritized. For example, new systems should be minimally complex, and trials should include people currently achieving suboptimal glycemic outcomes (e.g. high A1c, low time in range), as feasible.

Eligibility Criteria 

• Applications may be submitted by domestic and foreign non-profit organizations, public and private, such as universities, colleges, hospitals, 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. Please note that applications from for-profit entities or industry collaborations with academia may be submitted to this RFA; however, additional information will be requested from for profit entities if a full application is invited.
• There are no citizenship requirements for this program. To assure continued excellence and diversity among applicants and awardees, Breakthrough T1D 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 Breakthrough T1D.