The U.S. Food and Drug Administration issued draft guidance for manufacturers regarding the development of Low Glucose Suspend components of an artificial pancreas system on June 20.
An artificial pancreas system, under development, is an automated, closed-loop system that combines a continuous glucose monitor (CGM), an insulin infusion pump, and a glucose meter for calibrating the monitor. The devices would work together, monitoring blood glucose levels and automatically infusing appropriate doses of insulin as determined by a computer algorithm. The Low Glucose Suspend (LGS) system is the component that would respond to sensor readings of low or rapidly declining blood glucose levels by temporarily reducing or shutting down the delivery of insulin in order to avoid or mitigate hypoglycemia.
An LGS feature has been incorporated into Medtronic’s Paradigm Veo insulin pump/CGM system, which is currently available in about 45 countries around the world in Europe, Central and South America, Canada, South Africa, and Australia.
The draft guidance provides recommendations for companies planning to develop and submit an Investigational Devices Exemption or marketing application to the FDA for an LGS system intended for single patient use in the home environment. The guidance discusses critical elements regarding nonclinical testing and clinical studies needed to support such an application. The FDA is seeking input from industry, researchers, the clinical community, and other stakeholders on the document. Specifically, the FDA is seeking information on the types of clinical studies that should be conducted and what their target outcomes should be to demonstrate safety and effectiveness.
"Getting a safe and effective artificial pancreas system to Americans with type 1 diabetes is an FDA priority," Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the announcement.
The FDA currently is working on a second draft guidance that will help manufacturers and researchers develop more autonomous artificial pancreas systems. That document is expected to be issued by the end of the year.
Comments and suggestions regarding the draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Alternatively, electronic comments may be submitted to http://www.regulations.gov. All comments should be identified with the docket number listed in the notice of availability that gets published in the Federal Register.