Background & Purpose

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PURPOSE

JDRF is launching an initiative to accelerate the development of “open-protocol” automated insulin delivery (artificial pancreas) systems. JDRF is soliciting proposals from insulin pump manufacturers and continuous glucose monitor (CGM) manufacturers that will enable seamless, secure connectivity with other devices (e.g., by using Bluetooth technology). JDRF remains committed to supporting the traditional, proprietary commercial development of artificial pancreas systems; in parallel, JDRF will launch efforts in the United States and globally to partner with regulators and legal experts to establish predictable approval pathways for systems that allow for secure, open-protocol-based control through commercially developed devices and software.

BACKGROUND

For more than a decade, JDRF has played a leadership role in accelerating the development and commercialization of artificial pancreas (AP) systems that automate insulin delivery, defining a roadmap for increasingly sophisticated systems that would, with each generation, improve outcomes and reduce burden for people with T1D. Now, the first commercial system, which has been shown to provide significant benefit to people with diabetes, is on the market, and others are in development.

At the same time, a thriving community of users has rallied behind a patient-driven ecosystem, using do-it-yourself (DIY) approaches. In such systems, continuous glucose monitors and insulin pumps are reverse-engineered, allowing open-protocol efforts such as Nightscout, OpenAPS and Loop to display data in innovative ways and even to control automated insulin delivery. This DIY movement has grown rapidly, and JDRF believes that in order to support innovation and enable T1D families to use this approach safely, we must forge pathways to make devices compatible and enable open-protocol systems.

This new initiative will explore ways to overcome potential challenges in the use and adoption of open-protocol systems, most notably helping to establish clear financial, regulatory and legal frameworks. JDRF will enlist various experts and allies as part of this initiative, which will be led by JDRF Research Director Daniel Finan, Ph.D., under the direction of Chief Mission Officer Aaron Kowalski, Ph.D.