The algorithm used in Insulet‘s (NSDQ:PODD) closed-loop insulin delivery system performed well in a 58-patient safety and feasibility study, according to a study published today in Diabetes Technology & Therapeutics.
Insulet’s device, which is still in development, combines an insulin dosing algorithm, the OmniPod insulin patch pump and Dexcom‘s (NSDQ:DXCM) continuous glucose monitor into one system that automates insulin delivery based on the user’s blood sugar levels.
In the single-arm trial, participants managed their diabetes at home using their usual technologies for one week, followed by a 36-hour inpatient stay using the investigational OmniPod hybrid closed-loop system.
The system’s algorithm was originally developed at the University of California at Santa Barbara and is designed to make insulin-dosing decisions every five minutes based on values from Dexcom’s CGM.
“This multicenter, inpatient feasibility study demonstrated that the OmniPod personalized MPC algorithm performed well and was safe during day and night use over 36 h in adult, adolescent, and pediatric patients with Type I diabetes,” the researchers wrote. “Positive glycemic outcomes were consistently observed across age groups that included adolescents who are typically challenged by insulin resistance and children as young as 6 years of age with enhanced insulin sensitivity.”
The study’s authors noted that the algorithm was especially useful for controlling participants’ blood sugar at night – patients’ blood glucose levels remained within the target range more than 85% of the time.
The trial’s results are limited by a number of factors. The Insulet-funded study was short and held in a supervised setting, where healthcare workers managed the systems instead of the patients. Also, as the researchers noted, they did not design the trial to include a control arm.
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