Background & Purpose

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PURPOSE

JDRF is committed to expanding the reach of artificial pancreas (AP) systems and the benefits they can provide to people with type 1 diabetes (T1D) – of all ages and stages. While AP technology has evolved greatly over the last decade (one approved hybrid closed-loop system is currently available in several markets, and others are nearing the marketplace) much work remains to maximize adoption of and access to such systems among people with T1D. One focus area which can have a profound impact on expanding AP system usage in people with T1D is the generation of clinical evidence supporting the benefit of these devices – in terms of both biomedical and psychosocial outcomes – in targeted subpopulations which may have unique, unifying characteristics affecting AP effectiveness, safety, acceptance, and access. Demonstrating clinical success of AP systems in such populations may help improve adoption of and access to these devices. On the other hand, identification of safety, efficacy, and/or usability-related shortcomings may inform future development efforts and thereby also ultimately lead to increased adoption and access. JDRF challenges applicants to propose impactful clinical studies of AP technology (or, potentially, other non-clinical research) in targeted populations, providing novel, gap-filling evidence to advance our mission to expand the reach of life-improving AP technologies as widely as possible among people with T1D, at all ages and stages: “No (Type) One Left Behind.”

BACKGROUND

T1D is characterized by the loss of the body’s pancreatic beta cells which produce (among other things) insulin, a hormone that regulates blood glucose levels tightly in individuals without diabetes. With no endogenous insulin production, people with T1D rely on exogenous insulin. The delivery of this insulin, though, must be carefully regulated; too much insulin results in potentially acutely dangerous low glucose levels (hypoglycemia), while too little insulin can result in problematic high glucose levels (hyperglycemia) and/or a potentially dangerous condition known as diabetic ketoacidosis (DKA). In short, it is essential that a person with T1D is dosed the right amount of insulin at the right time. Moreover, even if a person with T1D were able to provide this degree of control, it would necessitate an unacceptably high burden of self-management.

AP devices [interchangeably, automated insulin delivery (AID) devices] are the most advanced device-based treatment option for people with T1D. These devices integrate three components to provide (at least partially) automated insulin delivery:

1) A continuous glucose monitor (CGM) which continuously measures glucose levels in the body,
2) An insulin pump, which has continuous access to the body to deliver insulin, and
3) An algorithm, which uses the information stream from the CGM and information about previously delivered insulin to calculate the optimal insulin infusion dose for the current conditions, and commands the insulin pump to deliver this calculated dose.