Development Of Devices And Drugs For Fully Automated Insulin Delivery At Meals Grant - Clinical Trials

Overview

Development Of Devices And Drugs For Fully Automated Insulin Delivery At Meals Grant - Clinical Trials

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. Toward the ultimate goal of achieving completely FCL AID systems, Breakthrough T1D invites letters of intent to develop technologies to allow for automated insulin delivery at meals.

Background

Today there are a number of AID systems commercially available globally. These HCL systems significantly improve glycemic outcomes and reduce the burden of diabetes management. However, the quality-of-life improvements conferred by today’s AID systems are limited by the requirement for manual user inputs to handle glucose changes associated with meals. Systems that can fully automate insulin delivery around meals promise to improve the experience of people already using AID systems and encourage others to try AID systems for the first time. Additionally, the vagaries of insulin action and glucose metabolism make it nearly impossible for users to perfectly calculate and time insulin doses before meals, and meal boluses are frequently late or missed altogether, especially among adolescents. Thus, for many, automated insulin delivery around meals is expected to improve glycemic outcomes like HbA1c and time in range.

Several types of technologies hold promise to achieve automated insulin delivery around meals. One is algorithms that can either anticipate or quickly recognize meals and deliver appropriate insulin boluses. Another is adjunctive (i.e. non-insulin) therapies that can diminish and/or delay post-prandial glucose excursions; insulin-pramlintide co-formulations fall into this category. A third approach is ultra-rapid insulin (URI). Currently, available subcutaneous insulins lag behind endogenously produced insulin in both onset and offset of activity, leading to post-prandial glucose excursions and delayed hypoglycemia. A sufficiently fast-acting subcutaneous URI has the potential to enable an algorithm to cover mealtime glucose excursions without a meal announcement. These three approaches are not mutually exclusive, and ultimately the best AID system with automated delivery around meals may require a combination of advanced algorithms and drugs. This RFA is intended to solicit projects to develop AID systems that are fully automated around meals or the individual components that comprise them.

Budget

Applications proposing clinical trials may request up to a total of $2,000,000 over a maximum of three years.

Eligibility

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