Background
What do we already know about this topic?
- Omnipod 5, powered by Horizon, is a wearable insulin-filled pod that communicates directly with a Dexcom G6 sensor.
- A personalized model predictive control algorithm is built into the pod, and a phone controller or PDM is used to start and stop the automated mode, deliver boluses, and change settings.
- The algorithm was safe and performed well in >13,000 person-hours of testing in 193 participants as young as 2 years of age.
How was this study conducted?
- The objective of this study was to assess the safety and effectiveness of the fully on-body system over 14 days of use prior to commencing a 3-month study phase.
- 18 children (mean age 10.6 years) and 18 adults (mean age 35 years) were enrolled.
- HbA1c was 7.8% in children and 7.1% in adults.
- The primary effectiveness endpoint was sensor glucose percentage time in target range (TIR) 70-180 mg/dL compared to standard therapy.