Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 System in Individuals With Type 1 or Type 2 Diabetes and Suboptimal Glycemia
Insulet Corporation
Summary
This multi-center, randomized, cross-over trial will evaluate the efficacy of the Omnipod 6 System compared with the Omnipod 5 System in individuals with type 1 or type 2 diabetes and suboptimal glycemia.
Description
Following a 2-week standard therapy phase for baseline data collection, participants will be randomly assigned to the order in which they receive Omnipod 6 or Omnipod 5. After completion of the first 13-week period, participants will cross-over to the opposite system for an additional 13 weeks. An optional 4-week extension will be offered to all participants to assess the response of the Omnipod 6 System with restricted boluses
Eligibility
- Age range
- 14–75 years
- Sex
- All