The FDA has issued draft guidance designed to help investigators and manufacturers as they develop and seek approval for artificial pancreas device systems to treat type 1 diabetes.
The draft guidance provides flexible recommendations for design and testing
that meet statutory requirements for safety and effectiveness. The draft guidance provides for flexibility in choice of study endpoints, number of patients to be studied and the length of the clinical trial.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.