The first FDA-approved insulin pump in the US will be marketed by Medtronic.
Patients in the US with type 1 diabetes will soon be able to purchase a new system from Medtronic that acts as an “artificial pancreas” . The closed-loop system is the first FDA-approved insulin pump that delivers basal insulin for controlling blood glucose levels.
The device received FDA approved in September 2016. A sensor inserted under the skin works in combination with the MiniMed 670G insulin pump and infusion patch that delivers insulin through a catheter, and an algorithm designed to learn a patient’s insulin needs over time. Background insulin levels of adjusted every five minutes based on the real-time data provided by the sensor.
The hybrid, closed-loop system is particularly effective during the nighttime when patients are not eating. The system cuts down on the overnight work and the constant vigilance required to manage diabetes, according to Dr. Bruce Buckingham, a Professor of Pediatric Endocrinology at Stanford University and a study investigator.
"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."
It is only a hybrid system, however. Patients still need to manually request bolus insulin before eating. A bolus typically takes 20 to 30 minutes to affect glucose levels. Patients are recommended to take insulin about 10 minutes before a meal. Buckingham noted that with faster-acting insulin it may be able to develop a fully automated system. Calibration of the sensor, which can be worn for up to seven days, is also required. Patients must also continue to track their carbohydrate intake.
Despite these limitations, the “artificial pancreas” has been well received. Medtronic rolled the system out in early 2017 to select patients as part of a “Customer Training Phase”. According to the company, the results of this program were positive: patients spent 74% of the time within their target blood glucose range and 92% of the time in auto mode. The company will initially be shipping the device to patients enrolled in its Priority Access Program.
Separately, it is worth noting that Senseonics and diabetes management company TypeZero announced in early May 2017 that they will be working to jointly develop an artificial pancreas system based on Senseonics’ Eversense CGM system implantable continuous glucose monitor.