Medtronic (NYSE:MDT) said data from a study of its closed-loop hybrid artificial pancreas, published in the Journal of the American Medical Assn., showed that the system is safe and effectively maintained blood glucose levels within range in Type I diabetes patients age 14 and older.
Results from the 3-month, 124-patient trial, also presented this week at the annual meeting of the European Assn. for the Study of Diabetes in Munich, had safety endpoints of the incidence of severe hypoglycemia and diabetic ketoacidosis, serious adverse events and device-related serious and unanticipated adverse events. Data from the study was 1st presented in June at the American Diabetes Assn.’s annual meeting.
The artificial pancreas system is designed to use Medtronic’s MiniMed 670G insulin pump, 4th-generation sensors and a control algorithm to automate basal insulin delivery to keep glucose levels in a healthy range as much as possible, 24 hours a day. Efficacy endpoints in the study included time in open vs. closed-loop systems; the percentage of sensor glucose values below, within, and above target range (71-180 mg/dL), including at night; changes in HbA1c, insulin requirements and body weight; and measures of glycemic variability.
On the safety front, there were no episodes of severe hypoglycemia or ketoacidosis over the trial’s 12,389 patient-day span, according to the JAMA report. There were 28 device-related adverse events that were resolved at home; non-device-related adverse events included 4 serious events (appendicitis, bacterial arthritis, worsening rheumatoid arthritis and Clostridium difficile diarrhea) and 117 events including 7 episodes of severe hyperglycemia due to intercurrent illness or other non-system causes.
In terms of efficacy, the device was in closed-loop mode for a median of 87.2% of the study period; sensor glucose values were within the target range 72.2% of the time at the end of the study, compared with 66.7% at baseline. The daily dose of insulin changed from 47.5 U/d to 50.9 U/d from baseline to the end of the study; weight changed from 169.5 lb. (76.9 kg) to 171.1 lb. (77.6 kg). Glycated hemoglobin levels changed from 7.4% at baseline to 6.9%.
“To our knowledge, this is the largest outpatient study to date and it demonstrated that hybrid closed-loop automated insulin delivery was associated with few serious or device-related adverse events in patients with Type I diabetes,” the researchers wrote. “Limitations include lack of a control group, restriction to relatively healthy and well-controlled patients, the relatively short duration, and an imbalance between the length of the study periods. Differences in HbA1c levels may be attributable to participation in the study. A similar study in children is under way. Longer-term registry data and randomized studies are needed to further characterize the safety and efficacy of the hybrid closed-loop system.”
“The data is compelling and shows that the system’s ability to automate insulin dosing 24 hours a day has the potential to impact patients’ lives in a very meaningful way – particularly at night when it’s most challenging to maintain target blood glucose levels,” principal investigator Dr. Richard Bergenstal, of the International Diabetes Center in Minneapolis, said in prepared remarks.
“We are pleased with the progress we have made in automating basal insulin delivery and that each new advancement in our phased approach delivers increased automation and greater peace of mind by helping to simplify diabetes management,” added Medtronic’s intensive insulin management president Alejandro Galindo. “We are committed to developing meaningful solutions like this to enable greater freedom and better health, so people with diabetes and their caregivers can spend less time managing the disease and more time enjoying life’s everyday moments.”
Medtronic said it June that it filed a pre-market approval application with the FDA for the hybrid closed-loop system.
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