Omnipod 6 (AID): review notes

Record: Omnipod 6 (AID)

Scope and findings:

• Registry protocol/status/outcome scope checked; NCT07579702: RECRUITING, primary completion {'date': '2027-02-22', 'type': 'ESTIMATED'}, {'count': 200, 'type': 'ESTIMATED'}; NCT06865989: COMPLETED, primary completion {'date': '2025-11-10', 'type': 'ACTUAL'}, {'count': 132, 'type': 'ACTUAL'}. No new results inferred from completion dates; product approval/access and older clinical scores are separate checks.
• Read STRIVE primary sponsor report: 132 total,98 T1D; 77% versus 73% is specifically T1D age 14+, not entire pediatric cohort. EVOLUTION3 is T2D; early T1D fully closed-loop work is explicitly announced, correcting prior blanket denial. Sponsor release is not a full peer-reviewed report.

Primary sources checked:

• clinicaltrials.gov
• clinicaltrials.gov
• investor.insulet.com

Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.

Additional second-pass scope: Unreleased-product scores explicitly provisional; commercial access0; removed trial-entry age from approved-age field. Omnipod6 TIR remains observed sponsor-reported33-person age14+ T1D subgroup, not all132randomized participants.

Primary sources checked:

• Primary source
• Primary source
• Primary source

Limits: Only the specific claims and scoring interpretation above were revisited. This does not revalidate every historical outcome or regional access claim.

Additional ranking review, 16 September 2026. Checked outcome attribution, generation differences, cohort comparability and criterion rationale against primary sources. Corrected false claims and added measured/provisional distinctions. Full findings and source-specific limits are in the AID ranking evidence audit. Numerical ratings were left to the central scoring calibration.

• https://clinicaltrials.gov/study/NCT06865989
• https://investor.insulet.com/news/news-details/2026/Insulet-Reveals-New-Data-Supporting-Breakthrough-Omnipod-6-and-Fully-Closed-Loop-AID-Systems-Designed-to-Improve-Outcomes-Reduce-Effort-and-Unlock-Barriers-to-Care/default.aspx
• https://investor.insulet.com/news/news-details/2025/Insulet-Outlines-Long-Term-Strategy-to-Drive-Growth-and-Value-Creation-at-2025-Investor-Day/default.aspx