FDA Approves Medtronic's "Artificial Pancreas" For Type 1 Diabetes
By Jof Enriquez,
Follow me on Twitter @jofenriq
The U.S. Food and Drug Administration (FDA) has approved Medtronic's "artificial pancreas" device, the MiniMed 670G, the first hybrid closed loop system that automatically monitors blood glucose and provides appropriate insulin doses with minimal user input.
The 670G system consists of a sensor that checks blood sugar levels every five minutes, a strap-on insulin pump, and a connected insulin patch that delivers (or withholds), as needed, micro-boluses of insulin via a catheter connected to the pump. Patients only need to enter mealtime carbohydrates, accept bolus correction recommendations, and periodically calibrate the sensor.
Medtronic submitted the pre-market application (PMA) for the device in June 2016, and expected FDA clearance to be granted within the year. The approval came sooner, backed by positive results of a 124-patient pivotal U.S. trial showing less glycemic variability, more time in the target range, less exposure to hypoglycemia and hyperglycemia, and reduced A1c values of those who used the MiniMed 670G device compared to baseline data using sensor augmented pumps.
"The FDA approval of the world's first hybrid closed loop system is a culmination of many years of hard work and close collaboration with the clinical and patient communities to generate the body of evidence needed to advance this technology for those living with diabetes," said Francine Kaufman, M.D., chief medical officer of the Diabetes Group at Medtronic, in a news release. "We appreciate the unprecedented speed by which the agency approved our PMA submission to help bring this advanced insulin pump therapy so quickly to U.S. patients living with this challenging disease. We are committed to preparing for commercial launch as quickly as possible while ensuring we provide the most successful rollout of this novel therapy."
Medtronic begins commercial release of the MiniMed 670G system in the spring of 2017 for treatment of people with type 1 diabetes 14 years of age and older. According to the Centers for Disease Control and Prevention (CDC), about five percent of the 29.1 million Americans with diabetes have type 1 diabetes, commonly diagnosed in children and young adults whose pancreas do not produce enough insulin.
FDA has made approving Artificial Pancreas Device Systems (APDS) a priority, and in the case of the MiniMed 670G, has "worked interactively with Medtronic from the earliest stages of development" to facilitate the device's approval.
“The FDA is dedicated to making technologies available that can help improve the quality of life for those with chronic diseases – especially those that require day-to-day maintenance and ongoing attention,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, in a news release. “This first-of-its-kind technology can provide people with type 1 diabetes greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin.”
FDA is requiring a post-market study be done for the indicated population for 14 years and older. Medtronic is also conducting clinical studies to evaluate the safety and effectiveness of the device in diabetic children 7-13 years old. The company likely would apply for expanded indication for those with type 2 diabetes, the most common form, whose incidence worldwide is growing rapidly.
"Type 2 diabetes is such an overwhelming spectrum of the disease and I think there's a significant slice of that pie that could benefit from the artificial pancreas," said Dr. Robert Courgi of Southside Hospital on New York's Long Island, reports the Associated Press.
A handful of university-based researchers and other medical device companies, including Dexcom and Johnson & Johnson, are working on artificial pancreas systems, as well.