The FDA has given the green light to the MiniMed 670G hybrid closed-looped system (Medtronic), the first agency-approved device that is intended to automatically monitor glucose and provide appropriate basal insulin doses in people 14 years of age and older with type-1 diabetes.
The MiniMed 670G hybrid closed-looped system, often referred to as an “artificial pancreas,” is intended to adjust insulin levels with little or no input from the user. It works by measuring glucose levels every five minutes and automatically administering or withholding insulin. The system includes a sensor that attaches to the body to measure glucose levels under the skin; an insulin pump strapped to the body; and an infusion patch connected to the pump with a catheter that delivers insulin. While the device automatically adjusts insulin levels, users must manually request insulin doses to counter carbohydrate (meal) consumption.
According to the Centers for Disease Control and Prevention, approximately 5% of people with diabetes have type-1 disease. Also known as juvenile diabetes, type-1 diabetes is typically diagnosed in children and young adults. Because the pancreas does not make insulin in people with type-1 diabetes, patients have to consistently monitor their glucose levels throughout the day and have insulin therapy through injection with a syringe, an insulin pen, or an insulin pump to avoid becoming hyperglycemic. In addition, the management of type-1 diabetes includes a healthy eating plan and physical activity.
The FDA evaluated data from a trial of the MiniMed 670G hybrid closed-looped system that included 123 participants with type-1 diabetes. The study consisted of an initial two-week period during which the system’s hybrid closed loop was not used, followed by a three-month study during which the participants used the system’s hybrid closed-loop feature as often as possible. The results of this study showed that the device is safe for use in people 14 years of age and older with type-1 diabetes. No serious adverse events, diabetic ketoacidosis, or severe hypoglycemia was reported during the study.
The risks associated with use of the system include hypo- and hyperglycemia, as well as skin irritation or redness around the device’s infusion patch. The approved version of the device is unsafe for use in children 6 years of age or younger and in patients who require less than 8 units of insulin per day.
As part of its approval process, the FDA is requiring Medtronic to conduct a post-marketing study to better understand how the device performs in real-world settings. While the device has been approved for use in people 14 years of age and older with type-1 diabetes, Medtronic is currently performing clinical studies to evaluate the safety and effectiveness of the device in diabetic children 7 to 13 years of age.
Source: FDA; September 28, 2016.