FDA today released draft guidance for artificial pancreas device systems for treatment of type 1 diabetes, an event one advocacy group is hailing as a “huge opportunity for patients.”

A press release issued by FDA says the draft guidance provides “flexible recommendations for design and testing” of the systems—including leeway in the choice of clinical study length and endpoints, as well as the number of patients— while still meeting criteria for safety and effectiveness.

Among the suggestions contained in the draft guidance were:

• A three-phase clinical study progression that would speed the path to outpatient studies
• Allowing sponsors to use existing safety and effectiveness data for their systems’ components and data from clinical studies conducted abroad to streamline clinical studies
• Giving sponsors the choice of showing that their systems provide glycemic control as well as or better than standard therapies

The draft guidance lays out a “roadmap to the first systems that will automatically dose insulin,” says Aaron Kowalski, lead researcher for the Juvenile Diabetes Research Foundation (JRDF), a group advocating development of artificial pancreas devices. That’s in contrast to an earlier draft guidance, released in June, that laid out recommendations for low glucose suspend device systems.

JRDF president and CEO Jeffrey Brewer calls the release of the draft guidance a “milestone event,” though he also cautions that the group would need more time to “fully digest” the document.

—Jamie Hartford