On March 20th, Insulet released key study results for its’ Artificial Pancreas, the Omnipod 5. For those that aren’t familiar with the Omnipod 5 Artificial Pancreas, it is the world’s first tubeless, wearable system that continuously adapts insulin delivery based on glucose levels and trends, significantly improved time in range and reduced HbA1c in children, adolescents, and adults, aged 6-70 years, with type 1 diabetes.
Omnipod 5 Study Overview
Here is how the Omnipod 5 study was conducted the following way:
- 128 Adults and teenagers between the age of 14 and 70.
- 112 Children between the age of 6 to 14.
- All participants began using the Omnipod 5 system at home for 3 months after an initial 14 days period of using manually managing the blood sugars using a their standard therapy (either multiple daily injections, or using a pump)
Omnipod 5 Study Results
The artificial pancreas showed a significant increase in time in range (70-180 mg/dL or 3.88 – 9.99 mmol/l):
Adults and Teenager Test Group
- This group spent 9% more time in range (up from 65% to 74%, or 2.2 extra hours a day)
- Adults and teenagers saw a decrease in HbA1c from 7.16% to 6.78%)
- Average sugar level decreased from 161 to 154 mg/dL or 8.93 to 8.54 mmol/l
- Target of 110 mg/DL or 6.1 mmol/l was achieved 76% of the time
Children Test Group
- Adults and teenagers spent 15% more time in range (up from 53% to 68%, or 3.7 extra hours a day)
- Adults and teenagers saw a decrease in HbA1c from 7.67% to 6.99%)
- Average sugar level decreased from 183 to 160 mg/dL or 10.15 to 8.87 mmol/l
Nearly all participants completed the pivotal study (98% of all participants) and almost everyone asked to continue using the artificial pancreas system after the study.
Insulet’s artificial pancreas system, the Omnipod 5 received breakthrough device designation from the U.S. Food and Drug Administration and is currently under review. The Company expects to launch Omnipod 5 in limited release during the first half of 2021.
Source: Insulet