Omnipod Closed-Loop Insulin Delivery System: hybrid closed-loop (HCL) system combines technology of CGM and insulin pumps, and a personalized, model-predictive control algorithm to deliver insulin day and night.
Adults with type 1 diabetes using the Omnipod hybrid closed-loop system (the HorizonTM Automated Glucose Control System) were studied in a supervised outpatient hotel setting with unrestricted meals and moderate-intensity exercise. They experienced significantly less hypoglycemia, more time in the target glucose range and better overnight glycemic control compared to their usual care, according to the study, “Safety and Performance of the Omnipod Hybrid Closed-Loop System in Adults with Type 1 Diabetes over Five Days Under Free-Living Conditions,” presented at the American Diabetes Association’s® (ADA’s) 78th Scientific Sessions® at the Orange County Convention Center Convention Center.
For people with type 1 diabetes (T1D), continuous glucose monitoring (CGM) devices provide around-the-clock information on glucose levels, which is then used to determine how much insulin is needed. Insulin pumps allow the insulin doses to be administered subcutaneously throughout the day. The new Omnipod hybrid closed-loop (HCL) system combines the technology of CGM and insulin pumps, using continuous glucose monitoring and a personalized, model-predictive control algorithm to deliver insulin throughout the day and night.
This study assessed the safety and performance of the Omnipod hybrid closed-loop system in adults with T1D over five days in a supervised hotel setting under free-living conditions. The study included 11 adults ages 18-65 years with T1D, with an average age of 28.8 years and an average diabetes duration of 14.9 years. The participants’ average HbA1c level was 7.4 and the average total daily dose of insulin was 0.67 U/kg. A seven-day phase of standard therapy, either continuous subcutaneous insulin infusion or multiple daily insulin injections, plus CGM use at home preceded the 96-hour HCL phase. Meals during the five-day HCL period were unrestricted, with participants making their own food choices and delivering insulin as they thought appropriate per their usual routine. Moderate-intensity exercise was performed for at least 30 minutes each day.
The results showed that the amount of time spent in the target glucose range of 70-180 mg/dl was 11.2 percent higher during HCL compared to standard therapy overall (73.7 percent and 62.5 percent, respectively). The time in the target range was also 13.2 percent higher overnight, with 73.9 percent for HCL vs. 60.7 percent for standard therapy. The percentage of time spent in hypoglycemia (< 70 mg/dl) was reduced during HCL vs. standard therapy, both overall (1.9 percent and 5.1 percent, respectively) and overnight (0.7 percent and 5.7 percent, respectively).
Chief investigator Bruce A. Buckingham, MD, professor of pediatrics, endocrinology and diabetes at Stanford University School of Medicine added that, “The Omnipod closed-loop system is an ‘untethered’ patch pump with no tubing, which is very attractive to some patients.”
“Previous studies showed that the Omnipod HCL algorithm was safe and performed well, and we were pleased to see that under free-living conditions it provides very good glucose control in a wide age range of subjects, especially overnight. Additionally, since the pump, sensor and transmitter are worn on the body at all times, the system has the potential to continue to function as a closed-loop system most of the time. The Omnipod can be very beneficial for people with type 1 diabetes, as it can function through many activities and allows patients to have full pump functions, like extended meal boluses and temporary basal rates, while using it.”
The Omnipod closed-loop system is an investigational device, limited by United States law to investigational use, and manufactured by Insulet Corporation (NASDAQ: PODD).
- The results showed that the amount of time spent in the target glucose range of 70-180 mg/dl was 11.2 percent higher during HCL compared to standard therapy overall.
- The Omnipod HCL algorithm was safe and performed well over 5 days of use in adults with T1D under free-living conditions with unrestricted meals and moderate-intensity exercise.