Omnipod® SmartAdjust 2.0 System Compared to the Omnipod® 5 System in Individuals With Type 1 or Type 2 Diabetes
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Phase
Not applicable
Status
Completed
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
132actual
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 | 2025-03-26 | actual | When the study began enrolling |
| Primary completion | 2025-11-10 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-11-10 | actual | The whole study's end, after follow-up |
| First posted | 2025-03-10 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-12-18 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Diabetes Mellitus, Type 1, Type 2
Interventions
- Device: Omnipod 5 SmartAdjust 2.0 System
- Device: Omnipod 5 System
Primary outcomes
what the primary-completion date above is the date OFPercent of time in range <54 mg/dL (non-inferiority margin of 0.75%)
measured End of Period 2 (Day 56) compared to Baseline
Percent of time in range <70 mg/dL (non-inferiority margin of 3.0%)
measured End of Period 2 (Day 56) compared to Baseline
Percent of time in range 70-180 mg/dL (non-inferiority margin of 3.0%)
measured End of Period 2 (Day 56) compared to Baseline
Mean Glucose (non-inferiority margin of 8 mg/dL)
measured End of Period 2 (Day 56) compared to Baseline
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