Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 System
← catalyst calendarNCT07579702 · readout in 187 d
Sponsored by Insulet Corporation (industry) · PODD — their whole pipeline →.
Phase
Not applicable
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
200estimated
Sites
11
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-05-13 | actual | When the study began enrolling |
| Primary completion | 2027-02-22 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-03-24 | estimated | The whole study's end, after follow-up |
| First posted | 2026-05-12 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-03 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Type 2 Diabetes Mellitus
- Type 1 Diabetes Mellitus
Interventions
- Device: Omnipod 5 System
- Device: Omnipod 6 System
Primary outcomes
what the primary-completion date above is the date OFTime in Range 70-180 mg/dL
measured 13 weeks
Time <54 mg/dL
measured 13 weeks
Time <70 mg/dL
measured 13 weeks
Time >180 mg/dL
measured 13 weeks
Time in Range 70-140 mg/dL
measured 13 weeks
HbA1c
measured 13 weeks
Mean sensor glucose
measured 13 weeks
Time >250 mg/dL
measured 13 weeks
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