FDA issues guidance for developing artificial pancreas
The FDA has issued draft guidance that seeks to help advance development and approval of an artificial pancreas to treat type 1 diabetes in the U.S., and Mayo Clinic researchers are already underway in developing such a device.
An artificial pancreas system is an automated, closed-loop system that combines a continuous glucose monitor, an insulin infusion pump and a glucose meter for calibrating the monitor. The FDA stated that the devices are designed to work together and administer automatic doses of insulin when determined by a computer algorithm.
The draft guidance addressed an early version of the pancreas system, known as a Low Glucose Suspend system (Medtronic), which can help reduce or lessen the severity of a dangerous drop in glucose levels by temporarily reducing or stopping the delivery of insulin, according to the FDA.
The agency is seeking input from industry, researchers, the clinical community and other stakeholders on the draft guidance, which can be found here. The agency is interested in what types of clinical evaluations should be performed to demonstrate product safety and effectiveness. Comments and suggestions regarding the draft should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.
“Our goal is to provide a clear pathway for artificial pancreas development so that people with diabetes can benefit from innovative medical devices,” said Jeffrey Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health. “Getting a safe and effective artificial pancreas system to Americans with type 1 diabetes is an FDA priority.”
The FDA said it is planning to release a second draft guidance by the end of the year that will help manufacturers and researchers develop more autonomous pancreas systems.
Researchers at the Mayo Clinic are currently in the process of developing an artificial pancreas. Endocrinologists Yogish C. Kudva, MBBS, and Ananda Basu, MBBS, MD, are working on a device that will deliver insulin automatically and precisely.
Later this month, they will present study findings on how everyday movements affect blood sugar at the 71 annual American Diabetes Association scientific sessions in San Diego. They plan to incorporate those findings into the “Closed-Loop System,” according to a Mayo Clinic release. The device under development includes a blood sugar monitor, an automatic insulin pump and a set of activity monitors that attach to the body, as well as a central processing unit.
Clinical trials on the Mayo device are likely to begin in November, according to the researchers, and study participants will follow strict diet, exercise and insulin delivery regimens in Mayo’s Clinical Research Unit. Data will be fed into the insulin delivery algorithm, which mimics the body’s natural process of monitoring and responding to glucose levels in the bloodstream.
An artificial pancreas system is an automated, closed-loop system that combines a continuous glucose monitor, an insulin infusion pump and a glucose meter for calibrating the monitor. The FDA stated that the devices are designed to work together and administer automatic doses of insulin when determined by a computer algorithm.
The draft guidance addressed an early version of the pancreas system, known as a Low Glucose Suspend system (Medtronic), which can help reduce or lessen the severity of a dangerous drop in glucose levels by temporarily reducing or stopping the delivery of insulin, according to the FDA.
The agency is seeking input from industry, researchers, the clinical community and other stakeholders on the draft guidance, which can be found here. The agency is interested in what types of clinical evaluations should be performed to demonstrate product safety and effectiveness. Comments and suggestions regarding the draft should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.
“Our goal is to provide a clear pathway for artificial pancreas development so that people with diabetes can benefit from innovative medical devices,” said Jeffrey Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health. “Getting a safe and effective artificial pancreas system to Americans with type 1 diabetes is an FDA priority.”
The FDA said it is planning to release a second draft guidance by the end of the year that will help manufacturers and researchers develop more autonomous pancreas systems.
Researchers at the Mayo Clinic are currently in the process of developing an artificial pancreas. Endocrinologists Yogish C. Kudva, MBBS, and Ananda Basu, MBBS, MD, are working on a device that will deliver insulin automatically and precisely.
Later this month, they will present study findings on how everyday movements affect blood sugar at the 71 annual American Diabetes Association scientific sessions in San Diego. They plan to incorporate those findings into the “Closed-Loop System,” according to a Mayo Clinic release. The device under development includes a blood sugar monitor, an automatic insulin pump and a set of activity monitors that attach to the body, as well as a central processing unit.
Clinical trials on the Mayo device are likely to begin in November, according to the researchers, and study participants will follow strict diet, exercise and insulin delivery regimens in Mayo’s Clinical Research Unit. Data will be fed into the insulin delivery algorithm, which mimics the body’s natural process of monitoring and responding to glucose levels in the bloodstream.