Medtronic’s hybrid closed-loop system, the world’s first “artificial pancreas,” is hitting the U.S. market. The system is the only FDA-approved insulin pump that automatically delivers basal insulin to control blood glucose levels in people with Type 1 diabetes.
The system includes a glucose sensor which measures glucose levels in the fluid just under the skin, the MiniMed 670G insulin pump and an infusion patch, which delivers insulin through a catheter. It uses an algorithm to self-adjust the delivery of basal, or background, insulin every five minutes based on real-time data gathered from the sensor.
"This technology is a significant breakthrough for the diabetes community and as a practicing endocrinologist, I have been awaiting this moment on behalf of my patients for a very long time," said Francine Kaufman, M.D., chief medical officer of Medtronic’s diabetes unit, in a statement. "The data demonstrating the benefits of this system are compelling and I'm confident it will simplify diabetes care for both patients and clinicians alike."
While the system eases the burden on patients who are constantly managing their glucose levels, it still requires (PDF) patients to track their carbohydrates and manually request bolus insulin at mealtimes. Patients must also calibrate the sensor, which may be worn for seven days, from time to time.
"The MiniMed 670G system has given me the confidence to manage my diabetes more independently," said Claire Bickel, a 14-year-old with Type 1 diabetes, in the statement. "This system gives me the freedom to focus on the many priorities I need to juggle in my life like field hockey, my school musical, spring track and schoolwork because I know it's taking care of me while I focus on these activities."
The company rolled the device out at limited U.S. sites in a “Customer Training Phase” earlier this year. Data from this program showed that patients spent 74% of time within their target blood glucose range and 92% of the time in auto mode. Patients may choose two other settings for their device: suspend on low, which stops insulin delivery once a pre-set limit has been reached, and suspend before low, which does so before the limit is met.
Next week, Medtronic will start shipping the system to patients enrolled in its Priority Access Program.
The devicemaker has come a long way from launching its first integrated insulin pump and continuous glucose monitor in 2006. While the hybrid closed-loop system is the first approved device of its kind, Medtronic says it is a step on the path to a fully automated system for insulin delivery.