The approval of the MiniMed 670G hybrid closed looped system to include individuals aged 7 to 13 with type 1 diabetes was expanded by the Food and Drug Administration(FDA). MiniMed 670G hybrid closed looped system is a diabetes management device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses with little or no input from the user. The FDA originally approved this device in September 2017 for use in patients 14 years of age and older with type 1 diabetes. The expanded approval of MiniMed 670G hybrid closed looped system was granted to Medtronic.
“Type 1 diabetes is a life-threatening chronic condition requiring continuous and life-long management that can be stressful for patients and their caregivers, especially when the patients are young children,” said FDA Commissioner Scott Gottlieb, M.D.
The MiniMed 670G hybrid closed looped system works by measuring glucose levels in the body every five minutes and automatically adjusting insulin delivery by either 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 need to manually request insulin doses to counter carbohydrate consumption at mealtime.
The device got the approval after evaluation of the data by FDA from a clinical trial of the MiniMed 670G hybrid closed looped system that included 105 individuals aged 7 to 11 years old. The participants of the study were asked to wear the device for approximately 3.5 months and participated in three phases of the study to evaluate both at-home uses as well as remote uses.
That study observed no serious adverse events associated with the use of the MiniMed 670G and found the device to be safe for use in people age 7 to 13 years with type 1 diabetes.
Some of the associated risks with the system may include hypoglycemia, hyperglycemia, as well as skin irritation or redness around the device’s infusion patch. The FDA has asked the product developer to conduct a post-market study to evaluate device performance in real-world settings in children between the ages of 7 and 13. However, this device is not approved for use in children 6 years of age or younger and in individuals who require less than eight units of insulin per day.
Our pancreas naturally supplies a low, continuous rate of insulin, known as basal or background insulin. When a person suffers from diabetes, the body’s ability to produce or respond to insulin gets hampered. As a result patients have to consistently monitor their glucose levels throughout the day and get insulin injection to avoid becoming hyperglycemic. Apart, from this, the effective management of type 1 diabetes also includes following a healthy diet and physical activity.