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type1.science
N/A (device / behavioral)RecruitingNCT07579702

STRIVE 2: Omnipod 6 compared with Omnipod 5

What this study tests

Insulet randomized crossover trial comparing investigational Omnipod 6 with Omnipod 5 in people with type 1 or type 2 diabetes and suboptimal glycemia. It is the confirmatory study behind the next Omnipod algorithm generation.

Editorial review: .

Registry checked: 2026-09-17. Registry’s own update: 2026-08-03.

Most recent recorded citation date: 2026-06-01. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.

Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence

Full sources ↓Full discussion ↓Report an issue →

Evidence at a glance

Who can enter the study?
People 14–75 with T1D for at least six months or T2D for at least a year, HbA1c at least 7.5%, current CGM use and fewer than four user-initiated boluses per day. Participants use basal-bolus injections or pump therapy; the registry lists additional device and safety requirements. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
Reported benefit and results
No results posted yet.Read the result sources and their limitations →
Important harms
Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
Research access and approval
Study regions: United States. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
What remains uncertain?
Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.

Research status alone does not establish approval, clinical benefit or local availability.

Primary endpoints

  • Time in range 70-180 mg/dL over 13 weeks
  • Time below 54 mg/dL over 13 weeks
  • Time below 70 mg/dL over 13 weeks
  • HbA1c over 13 weeks

The full picture

This record has no longer discussion. Use the study criteria, reported results and original sources on this page to assess what is known and what remains unresolved.

Sources

  1. [1]