Medtronic has been advancing artificial pancreas research and development for … our path to the artificial pancreas, a study of our Hybrid Closed Loop (HCL) system.
Type I diabetes comes with a lifetime commitment to maintaining health. Patients have to measure blood glucose levels and adjust insulin levels as necessary as indicated by multiple finger stick blood tests daily. Glucose monitors can reduce the number of finger sticks to two a day for calibration to be sure the monitor is working accurately. Any progress in maintaining or improving blood glucose management with less personal attention is a win. On that basis, testing completed and reported on earlier this month by medical device giant Medtronic is a huge win.
The system includes a Medtronic MiniMed 670G insulin pump, fourth-generation glucose sensors and a control algorithm. In addition to the system itself, researchers monitored blood glucose levels more than four times daily via traditional finger-stick monitoring as well as via Abbott’s i-STAT handheld device. Patients also calibrated the closed-loop sensors periodically.
The three-month study found that the hybrid closed-loop system resulted in a mean reduction of A1c to 6.9% +/- 0.6% from 7.4% +/- 0.9%. This was the primary outcome measure of the study. The standard recommendation is to reduce HbA1c to
Sensor glucose levels varied only slightly from baseline level established during a 2-week lead-in period. At the end of the study, 99 of the participants opted to enter the continued-access program for the hybrid closed-loop device.
“The HCL system was safe, acceptable, and associated with improved glucose control during extended at-home use,” the researchers concluded.
A separate study of 12 adults and 16 adolescents found that overnight use of the closed-loop system improved time in the target glucose range for the adults and reduced nocturnal hypoglycemia in the adolescents.
Medtronic has previously said that it will submit this month to the FDA for its hybrid closed-loop system, with an approval anticipated for next spring.
For its part, smaller competitor Insulet also updated on its own artificial pancreas ambitions. Its artificial pancreas system incorporates its Omnipod insulin platform along with a DexCom continuous glucose monitor that’s controlled by an algorithm it in-licensed from Mode AGC in February.
Building on the breakthrough technology in the MiniMed 640G system, the Hybrid Closed Loop system is designed to automatically control glucose levels 24 hours a day with less input from patients. People using the system will only need to enter their carbohydrates at mealtime, and calibrate the sensor periodically, significantly simplifying today’s diabetes management routines.
“Insulin pumps and continuous glucose monitoring systems have greatly improved the ability for people with diabetes to achieve better glucose control and live longer, healthier lives,” said Satish Garg, M.D., professor of pediatrics and medicine and director of the adult diabetes program at the University of Colorado Barbara Davis Center for Childhood Diabetes. “However, even with these systems, patients must make hundreds of decisions each day. Simplifying this self-management with a more automated Hybrid Closed Loop system would have a very meaningful impact on these patients’ lives.”
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