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
- Healthy volunteers
- No
Inclusion Criteria: * Age at time of consent 14-75 years (inclusive) * Type 1 diabetes diagnosis for at least 6 months or type 2 diabetes diagnosis for at least 1 year, based on Investigator's clinical judgment * Basal/Bolus insulin delivery via multiple daily doses or insulin pump with or without automation * HbA1c ≥ 7.5% * Average # of user-initiated boluses less than 4 per day over the 14 days prior to screening through review of device data or self-reported if non-pump user * Average # of user-initiated boluses less than 4 per day over 14 days, during Standard Therapy Phase through review…
Interventions
- DeviceOmnipod 5 System
The Omnipod 5 System with the study CGM
- DeviceOmnipod 6 System
The Omnipod 6 System with the study CGM
Locations (12)
- University of Southern CaliforniaLos Angeles, California
- Sansum Diabetes Research InstituteSanta Barbara, California
- University of ColoradoAurora, Colorado
- YaleNew Haven, Connecticut
- University of South FloridaTampa, Florida
- Emory UniversityAtlanta, Georgia