On June 21, 2018, the FDA granted Medtronic expanded approval to market the MiniMed 670G hybrid closed looped system, 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, to individuals aged seven to 13 with type 1 diabetes. The FDA originally approved this device in September 2017 for use in patients 14 years of age and older with type 1 diabetes.
“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. “Caregivers and families of young patients with diabetes face unique challenges in managing this disease, in particular the round-the-clock glucose monitoring that can be disruptive to people’s lives. Advances in science, technology and manufacturing are contributing to the development of new and expanded uses of products that can help improve the quality of life for those with chronic diseases, especially vulnerable populations, like children. Today we’re extending these opportunities to younger children who are especially vulnerable to the impact of this disease, such as the disruptions in sleep that can be caused by the need for frequent blood glucose checks.”
The human pancreas naturally supplies a low, continuous rate of insulin, known as basal or background insulin. In patients with diabetes, the body’s ability to produce or respond to insulin is impaired. Because the pancreas does not make insulin in people with type 1 diabetes, patients must consistently monitor their glucose levels throughout the day and inject insulin with a syringe, pen, or pump to avoid becoming hyperglycemic (high glucose levels). In addition, management of type 1 diabetes includes following a healthy eating plan and physical activity.
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 FDA evaluated data from a clinical trial of the MiniMed 670G hybrid closed looped system on individuals aged seven to 11 years old. That study found no serious adverse events associated with use of the MiniMed 670G and that the device is safe for use in people aged seven to 13 years with type 1 diabetes.
Risks associated with use of the system may include hypoglycemia, hyperglycemia, as well as skin irritation or redness around the device’s infusion patch. As part of this approval, the FDA is requiring the product developer to conduct a post-market study to evaluate device performance in real-world settings in children between the ages of seven and 13. This device is not approved for use in children six years of age or younger and in individuals who require less than eight units of insulin per day.
See the FDA Announcement
See also Medical Risk Law Report: Diabetes and Its Complications: Malpractice and Other Liability Issues
See also Medical Risk Law Report: Blood Draws, Testing, Transfusions: Venipuncture Injury, Inaccurate Results, Tainted Blood – The Liability Risks