FDA Issues Final Artificial Pancreas Guidance

The U.S. Food and Drug Administration (FDA) announced on November 9 the issuance of its final guidance for the development of artificial pancreas systems. The guidance incorporates nearly all of JDRF’s recommendations. This news represents a milestone victory for JDRF and the type 1 diabetes (T1D) community, as the technology is viewed by medical experts as potentially the most revolutionary advance in T1D treatment since the discovery of insulin in 1921.

Artificial pancreas (AP) systems combine a continuous glucose monitor (CGM) and an insulin infusion pump and automate their functions by way of a portable computer running a sophisticated algorithm. The technology, in development in numerous laboratories across the country but not yet approved by the FDA, has the potential to address the serious problem of blood-glucose control that exists for many people with T1D using current treatments. The FDA guidance is a crucial step forward in JDRF’s effort to accelerate development of the technology, as it clearly spells out the agency’s expectations for human clinical trials and marketing of the devices.

JDRF convened the Artificial Pancreas Consortium, a group of leading endocrinologists and glucose-control theorists working in collaboration with mathematicians and engineers, in 2006. The same year, the FDA named AP systems to its Critical Path Initiative, the agency’s official strategy to drive innovation in the scientific process through which medical products are developed, evaluated, and manufactured. In March 2011, JDRF proposed that the FDA issue guidance as a means to help accelerate the development of AP systems. JDRF worked with clinical experts in the field to draft a set of recommendations for that purpose.

JDRF then mounted an advocacy campaign to urge the FDA to produce draft guidance by the end of 2011. A petition circulated by JDRF to that effect received more than 100,000 signatures. Clinicians and members of the Senate and House of Representatives each wrote a letter to the FDA adding that group’s support to JDRF’s request. And in June 2011, the 155 young delegates of JDRF’s Children’s Congress pressed the issue in meetings with their members of Congress and in testimony to a specially convened Senate panel.

On December 1, 2011, the efforts of JDRF and the T1D community were rewarded when the FDA issued its draft guidance. JDRF consulted its expert panel once again and in March 2012 provided a second round of recommendations in response to the draft guidance.

JDRF is highly encouraged that in its final guidance, the FDA accepted nearly all the recommendations made by JDRF and the clinical community. The guidance allows for a range of scientifically valid study designs, which will encourage innovation while ensuring thorough evaluation of AP systems. Additionally, the guidance recognizes “time in range” and other measures of blood-glucose control as potential endpoints in clinical trials. It allows sponsors the ability to propose statistical measures of efficacy that are tailored to their systems. And it accepts the use of CGM data in evaluating AP systems.

In March, the FDA gave the green light to the very first outpatient clinical trial of an AP system. That trial is currently under way and will provide valuable data on the performance of an AP system outside the hospital setting. JDRF will continue to work with the FDA as AP systems are developed and enter clinical trials.