In type 1 diabetes, the pancreas produces little or no insulin, an essential hormone necessary for controlling blood sugar. People with type 1 diabetes have to monitor their blood sugar throughout the day, and calculate how much insulin they need to lower their blood sugar, which is delivered using a syringe or insulin pump.
An artificial pancreas system combines an insulin pump and a continuous glucose monitor with a sensor placed under the patient's skin. The pump and monitor work together, tracking blood sugar and automatically pumping measured doses of insulin as determined by a computer algorithm.
These systems help eliminate, or reduce the severity of dangerous drops in blood sugar by stopping insulin administration when blood sugar levels near a predetermined threshold.
The device is not a cure, but it might reduce dangerous high and low blood sugar levels, giving patients a better quality of life and reducing the risk of diabetes-related complications, the FDA said.
The new guidelines recommend a three-phase clinical study progression "so that studies may move to an outpatient setting as quickly as possible." The agency is also suggesting other ways to streamline the testing process, including ways to use existing safety and effectiveness data for the components that make up the system, and allowing data from clinical studies done outside of the United States to be used in the approval process.
In addition, those conducting the clinical trials have the option of demonstrating that the system controls blood sugar as well as standard therapies, or showing that it gives better blood sugar 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," the FDA said.
In June, the FDA released a draft guidance on safety an
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