FDA Issues Draft Guidance for the Development and Approval of the Artificial Pancreas

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The U.S. Food and Drug Administration (FDA) issued draft guidance designed to help investigators and manufacturers as they develop and seek approval for artificial pancreas device systems to treat type 1 diabetes. This step comes after a large campaign led by the Juvenile Diabetes research Foundation (JDRF) pushing the FDA to set reasonable guidelines for the development of the artificial pancreas. JDRF’s campaign included a petition signed by 110,000 diabetes advocates asking the FDA to issue draft guidance by December 1, as well as placing powerful full-page advertisements in the New York Times and the Washington Post.

To facilitate development of this novel product in an evolving area, the draft guidance provides flexible recommendations for design and testing that meet statutory requirements for safety and effectiveness. For example, the draft guidance provides for flexibility in choice of study endpoints, number of patients to be studied and the length of the clinical trial.

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. 

Following the FDA’s announcement JDRF said it is encouraged by the issuance of the draft guidance which appear to lay a foundation for accelerating the development and availability of artificial pancreas technology (AP) that will improve the lives of millions of Americans living with type 1 diabetes.

“Our initial review of the draft AP guidance indicates that the FDA has been responsive and listened to the recommendations of leading clinicians and researchers in the type 1 diabetes field,” said Jeffrey Brewer, President and CEO of JDRF. “It also appears that the draft guidance lays out a rapid timetable to move from inpatient trials to outpatient trials to prove the AP’s safety and efficacy, and if that turns out to be the case it is good news.”

Click here to see a video of the Artificial Pancreas being tested in Israel.

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