FDA issues draft guidance on artificial pancreas system

U.S. Food and Drug AdministrationDec 2 2011

To facilitate development of this novel product in an evolving area, the draft guidance provides flexible recommendations for design and testing that meet statutory requirements for safety and effectiveness. For example, the draft guidance provides for flexibility in choice of study endpoints, number of patients to be studied and the length of the clinical trial.

"The FDA is focused on improving the process for the study and approval of artificial pancreas systems, and developed this guidance to provide maximum flexibility to manufacturers seeking to bring this device to U.S. patients," said Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health. "We understand how this device could change the lives of millions of Americans with diabetes, and we want our safety and effectiveness review to give patients the confidence that the device works."

Type 1 diabetes is a serious, chronic condition in which the pancreas produces little or no insulin, a hormone needed to properly control blood glucose (sugar) levels. People with type 1 diabetes must monitor their blood sugar using a glucose meter throughout the day, calculating how much insulin is needed to lower their blood glucose levels, and administering the necessary dose using a syringe or insulin pump to deliver insulin into subcutaneous tissue.

An artificial pancreas system does not involve synthetic or artificial tissue or organs. Instead, it combines two medical devices, an insulin pump and a continuous glucose monitor or CGM that receives information on glucose levels from a sensor placed under the patient's skin. The pump and CGM work together, monitoring the body's glucose levels and automatically pumping appropriate doses of insulin as determined by a computer algorithm.

While not a cure, an artificial pancreas could reduce dangerous high and low blood sugars, providing a better quality of life for those with diabetes and lowering the risk for future diabetes-related complications.

The guidance recommends a three-phase clinical study progression so that studies may move to an outpatient setting as quickly as possible. To further streamline clinical studies, the guidance suggests ways sponsors may leverage existing safety and effectiveness data for components that may make up an artificial pancreas system, as well as data gathered from clinical studies conducted outside of the U.S.

Sponsors also have the choice of showing that the system provides glycemic control as well as standard therapies, or showing that it provides better glycemic control when compared to other therapies.

When final, the guidance will help manufacturers and investigators assemble submissions for clinical trials as well as product approval submissions.

In June, the FDA issued a draft guidance outlining the agency's expectations about the nonclinical testing and clinical trials for a first-generation artificial pancreas system called a Low Glucose Suspend System. Such a system helps eliminate, or reduce the severity of, a dangerous drop in blood glucose levels by temporarily suspending insulin delivery when glucose levels approach a low threshold.

Today's guidance was informed by the comments on the Low Glucose Suspend System guidance document. It addresses future generation artificial pancreas devices such as a treat-to-range system that would adjust insulin dosing if a person's glucose level approaches a low or high threshold and a treat-to-target system that would set target glucose levels and try to achieve these levels at all times. This system would be fully automated and require no interaction from the user, except for calibration of the CGM system.