Omnipod 6 (AID)

Omnipod 6 is Insulet’s planned successor to Omnipod 5, targeting a 2027 launch. FDA cleared the software-only Omnipod 6 algorithm on 29 June 2026 for T1D from age 2 and T2D from age 18. This supersedes the algorithm’s investigational status in the earlier June announcement; it does not establish commercial clearance or availability of the complete pump system.⁴⁶

What changes

Insulet’s roadmap describes a configurable tubeless Pod and new app/controller experience. FDA’s algorithm summary now documents adaptation to insulin history and bolus behavior, automatic micro-boluses every five minutes and a 100–150 mg/dL target range. Final Pod dimensions, water rating and commercial sensor combinations remain unconfirmed; Omnipod 5 hardware specifications should not be assumed to apply.⁴⁶ The 100 mg/dL target is also available on enhanced US Omnipod 5.⁵

Pivotal evidence (type 1 arm)

The randomized crossover STRIVE study (NCT06865989) enrolled 132 people: 98 with type 1 and 34 with type 2 diabetes. Each system was used for four weeks, comparing Omnipod 6 at 100 mg/dL against Omnipod 5 at 110 mg/dL. The headline type 1 result concerns 33 participants aged 14–70: TIR was 77% versus 73%, and tight-range time was 54% versus 47%.¹² Different targets mean this does not establish an algorithm-only advantage over today’s enhanced Omnipod 5 at 100 mg/dL. The subsequent reduced-bolus phase reported 76% TIR in that age group with 2.2 fewer boluses per day; it was not a randomized meal-free comparison.² The numerical subgroup results here come from the manufacturer’s conference announcement. FDA’s subsequent summary reports noninferiority for the primary endpoints (time below 54 and 70 mg/dL, TIR and mean sensor glucose), with improvements described as exploratory; it supplies no numerical outcome tables or noninferiority margins.⁶ STRIVE 2 is recruiting an estimated 200 participants aged 14–75 with type 1 or type 2 diabetes, HbA1c at least 7.5%, and fewer than four user-initiated boluses per day. It compares 13-week treatment periods; the registry estimates primary completion on 22 February 2027, not publication of results on that date.³

STRIVE also included 34 participants with type 2 diabetes. Insulet’s June announcement reported TIR of 76% versus 73% and tight-range time of 48% versus 43% during the crossover. The subsequent Bolus Optional Phase had 74% TIR and 2.5 boluses per day. These are type 2 results, not evidence of performance in type 1; they are not the basis of this page’s type 1 ratings.²

Access

The manufacturer’s 2027 target is a development plan, not a confirmed launch date. The cleared algorithm’s US ages are T1D age 2+ and T2D age 18+; those do not establish commercial supply or every final system configuration. Regional rollout, water rating, reservoir capacity, wear duration and price remain unconfirmed here. No Omnipod 5 hardware specification is carried forward as an established Omnipod 6 specification.⁴⁶

Separate fully closed-loop development

Insulet’s EVOLUTION 3 feasibility and EVOLVE pivotal studies concern fully closed-loop delivery in type 2 diabetes. Its June 2026 release also states that early fully closed-loop work in type 1 is underway, without establishing a T1D efficacy result or launch date. These programmes should not be conflated with Omnipod 6’s hybrid-loop STRIVE results.²

How to read this pipeline score. Scores remain editorial judgments, with projections where final hardware or outcomes are unreported. FDA algorithm labeling and trial entry criteria are different sources. A study result applies only to its studied population and does not establish future commercial performance or access.