FDA APPROVES NEW DEVICE FOR MANAGEMENT OF TYPE I DIABETES
WorldPath Health MEDICAL INFORMATION BULLETIN – FOR IMMEDIATE RELEASE, CAMBRIDGE, MA, November 6, 7:00 AM:
The management of diabetes is extremely important and control of blood levels of glucose is closely tied to prevention of complications of the disease. Management of type I diabetes in particular remains challenging despite current technologies. The FDA has just approved a new technology for management of Type I diabetes which can help minimize glycemic variability in type I diabetes. The system is approved for patients with type I diabetes aged 14 y and older.
It comprises an insulin pump, a continuous glucose monitor, and is controlled using an electronic algorithm that allows the 2 devices to communicate. Patients using the device show a reduction in glycemic variability and increased time in target range.
Clinical studies are in progress to evaluate safety and effectiveness of the device in children 7-13 y old with type 1 diabetes. This device version is currently considered unsafe for use in children 6 y of age or younger and in patients who require <8 units of insulin per day. As part of this approval, the FDA is requiring a study to better understand how the device performs in real-world settings..
WorldPath Health is closely involved in the evaluation of this and other new technologies in the management of diabetes and employees the most advanced technologies available for the diagnosis, treatment, and management of diabetes.
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