The FDA today issued a draft guidance with recommendations for clinical trials for certain devices intended for treating diabetes.
Included in the guidance are recommendations for feasibility and early feasibility clinical studies for certain medical devices intended to therapeutically improve glycemic control in patients with type 2 diabetes mellitus, independent of medication delivery.
Among the devices covered by the guidance are neurostimulators and those that mimic or result in anatomical changes similar to those made by bariatric surgical procedures, alter the anatomy and/or physiology of the small intestines or manipulate the sympathetic nervous system.
Dr. Jeff Shuren, the director of the FDA’s Center for Devices and Radiological Health, said in the release that the prevalence of type 2 diabetes in the U.S. has resulted in a growing interest among medical device manufacturers and researchers to develop therapeutic devices designed to improve glycemic control.
Currently, there are no legally marketed medical devices in the U.S. that are intended to do so, Shuren said, while the diabetes community only has FDA-cleared and approved devices for measuring and monitoring blood glucose, as well as dosing and delivering insulin.
“As part of our commitment to help accelerate the development of innovative medical devices to improve patient care, the draft guidance issued today provides the FDA’s initial thinking on feasibility and early feasibility clinical studies for certain medical devices intended to improve glycemic control,” Shuren said. “With our focus on improving public health and making technologies available that can help improve the quality of life for those with chronic diseases like Type 2 diabetes, we’re interested in getting feedback from manufacturers as well as the diabetes community on this draft guidance.”