Insulet recently shared positive results from a study testing the Omnipod Horizon, a closed-loop tubeless insulin pump system, in children as young as two years of age. The study examined the safety and effectiveness of the experimental closed-loop system in a non-clinical setting.
For the study, children with type 1 diabetes who were between the ages of 2 years old and just under 6 years old, along with their families, were given an experimental Omnipod Horizon pump and continuous glucose monitor (CGM) system for the children to use during a hotel stay in a supervised setting. The Hybrid system utilized readings from a CGM to automatically adjust basal insulin delivery. Before the hotel stay, the participants followed standard care with a CGM which did not include an insulin pump.
Researchers then compared the blood glucose trends of the two periods of time for the participants. What they found was that the pediatric trial participants stayed in an optimal blood glucose range between 70 mg/dL and 180 mg/dL for 73% of the time while wearing the pump during the study, including 85% of the time during nighttime hours. Trial participants also spent significantly less time with blood glucose levels at or above 250 mg/dL with the pump system.
It should be noted that this was a small study of just 14 participants, according to the abstract presented at the ADA. The study’s original recruitment listing shows that researchers hoped for an estimated enrollment target of 150 participants.
The hotel-based study, which allowed participants to have unrestricted meals and opportunities for exercise, builds on positive results of a 2017 trial with the Horizon system in a clinical setting. Insulet hopes to gain FDA approval for the hybrid closed-loop insulin delivery system in time to ready it for commercial release in mid-to-late 2020.
The lead photo above is of Insulet’s Omnipod Dash pump system. A photo of the Omnipod Horizon has not yet been made available with news of the study.