Silver Spring, Maryland, USA: The U.S. Food and Drug Administration, FDA, expanded the approval of 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 include individuals aged 7 to 13 with type 1 diabetes, on Thursday. 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 FDA is dedicated to promoting policies that support the development of new technologies based on these advances, and to ensuring that the path to market is both efficient and effective.”
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. Type 1 diabetes, also known as juvenile diabetes, is typically diagnosed in children and young adults.
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 that included 105 individuals aged 7 to 11 years old. Study participants wore the device for approximately 3.5 months and participated in three phases of the study to evaluate both at-home use as well as remote use. That study found no serious adverse events associated with use of the MiniMed 670G and that the device is safe for use in people age 7 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 7 and 13. 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.
The expanded approval of MiniMed 670G hybrid closed looped system was granted to Medtronic.
The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
“We are thrilled to be able to offer this advanced insulin management system to younger patients and their caregivers to help alleviate some of the burden associated with this unrelenting disease and to improve their quality of life,” Dr Francine Kaufman, chief medical officer and vice president of global regulatory, medical and clinical affairs of the Diabetes Group at Medtronic, said in a statement. “This expanded age indication provides an important new treatment option for pediatric clinicians and parents of young children with type 1 diabetes, and further demonstrates our strong commitment to improving outcomes across the full diabetes care continuum.”