By Jonathan Springston, Assistant Editor, AHC Media
The FDA on Sept. 28 approved a device that automatically monitors glucose and provides appropriate basal insulin doses in patients ≥ 14 years of age suffering from type 1 diabetes. The breakthrough device could provide these patients more freedom to live without the hassle of continuous blood sugar monitoring.
The MiniMed 670G measures glucose levels every five minutes, automatically administering or withholding insulin. The device features a sensor that attaches to the body to measure glucose levels under the skin, an insulin pump that straps to the user, and an infusion patch connected to the pump with a catheter that delivers insulin. Although the device has been dubbed the “artificial pancreas,” users must manually adjust insulin doses to counter carbohydrate intake.
To test the device’s efficacy, the FDA considered data from a clinical trial that included 123 type 1 diabetes patients ≥ 14 years of age. During the trial, these participants did not use the device for the first two weeks, then started using it as much as possible for three months. Researchers noted no serious adverse events, including diabetic ketoacidosis or severe hypoglycemia.
Though the device shows promise, manufacturers warn there are some potential risks that may include hypoglycemia, hyperglycemia, and irritation or redness around the device’s infusion patch. The FDA says it will require the device manufacturers to conduct a post-market test to determine how the MiniMed performs in the real world. Additionally, while the product is not approved for patients ≤ 14 years of age, the FDA says there will be more research to determine if MiniMed could be safe for these patients.
“We encourage companies to work closely with the agency to ensure scientifically sound, highly efficient clinical study designs, helping to expedite the FDA’s evaluation and subsequent approval of novel devices that can make a difference for patients,” Alberto Gutierrez, Ph.D, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in a statement.