Omnipod 6 (pump)
Insulet
What it is
Insulet’s planned tubeless pump successor, targeting 2027. FDA cleared the Omnipod 6 algorithm on 29 June 2026; that software clearance does not establish commercial access to the complete pump system. Final Pod capacity, wear duration, dimensions, water rating and commercial sensor combinations remain unconfirmed here.
Editorial review: .
Most recent recorded citation date: 2026-08-03. 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
Evidence behind this assessment
Key evidence notes. Study results, product eligibility and access answer different questions.
- Who was studied?
- Study populations and analysis groups vary. Product age limits alone do not describe who was studied.See the linked studies and their populations →
- Benefit or performance
- Reliability: In the 132-participant STRIVE randomized crossover and extension study (NCT06865989), FDA K261461 reported zero DKA, zero severe hypoglycemia, and zero serious adverse events; builds on the commercial Pod hardware platform.[1]
- Important harms and treatment burden
- Read the safety discussion and original sources. A missing summary does not establish safety.
- Approval and country access
- Country-specific approval and access are not summarized in this record.Approval, trial recruitment, local supply and funding are separate. Check the cited label or access source.
- Follow-up and remaining uncertainty
- Read the full discussion and original sources for follow-up duration and study limitations.
Research status alone does not establish approval, clinical benefit or local availability. This record cites company or conference reports. Those sources may describe interim findings; their source type is shown in the source list.
Editorial score: calculation and evidence
A weighted editorial judgment on a 0–100 scale, not a probability of success or a measured treatment effect. Higher criterion scores mean more favorable assessments.
Score limitations. Provisional pipeline ratings reflecting the FDA-cleared Omnipod 6 algorithm (K261461), STRIVE crossover trial (NCT06865989), and configurable tubeless Pod roadmap ahead of the targeted 2027 commercial launch.
Default calculation: 78 × 20 + 64 × 20 + 93 × 20 + 88 × 15 + 58 × 10 = 6600; divide by total weight 85. Unrounded weighted result: 77.6470588235294. (Access & cost is excluded from the weighted score until commercial launch.)
FDA-cleared SmartAdjust 2.0 interoperable automated glycemic controller (K261461) and ACE pump architecture built on the Omnipod 5 multi-sensor Dexcom/Libre ecosystem.[1]
In the 132-participant STRIVE randomized crossover and extension study (NCT06865989), FDA K261461 reported zero DKA, zero severe hypoglycemia, and zero serious adverse events; builds on the commercial Pod hardware platform.[1]
Fully tubeless, self-adhesive on-body Pod architecture with configurable Pod options and no tubing to snag or disconnect.[2]
Next-generation smartphone app and controller experience hosting the FDA-cleared SmartAdjust 2.0 controller and SmartBolus Calculator with on-Pod closed-loop execution.[1]
On the horizon — not yet commercially available. FDA cleared the Omnipod 6 algorithm on 29 June 2026 (K261461); full commercial launch is targeted for 2027.[2]
Editor’s take
A tubeless Pod can matter to daily life independently of glucose outcomes. Omnipod 6 is a concrete programme with an FDA-cleared algorithm (K261461) and positive STRIVE crossover data, targeting a 2027 commercial launch.
The full picture
Algorithm clearance and pump access are different milestones. FDA cleared the software-only Omnipod 6 algorithm on 29 June 2026 under K261461, for type 1 diabetes from age 2 and type 2 diabetes from age 18. The submission describes separate algorithm, ACE pump and SmartBolus Calculator components. It does not establish that the complete Omnipod 6 pump system is commercially available. Insulet’s roadmap targets a 2027 launch.12
Tubeless design, water and wear. Insulet describes a configurable on-body Pod and a new app/controller experience. The reviewed sources do not establish final Omnipod 6 reservoir capacity, wear duration, dimensions, water-resistance limits or a commercial phone/sensor compatibility list. In particular, Omnipod 5’s water rating cannot be assigned to its successor. Tubeless wear is a meaningful design feature; comparative comfort, swimming freedom and reliability still require the actual product specifications and use evidence.21
What the cleared algorithm does. The FDA summary describes a hybrid closed-loop controller that adjusts insulin every five minutes using a 60-minute prediction horizon, with glucose targets from 100 to 150 mg/dL (about 5.6–8.3 mmol/L). Its adaptive rate incorporates insulin history and bolus behavior. The software resides on the Pod and app; a compatible smartphone or Insulet controller is described. These are documented algorithm features, not confirmation of every proposed commercial CGM pairing.1
Direct Omnipod 6 evidence. The FDA summary describes STRIVE as a randomized crossover study in 132 participants: 98 with type 1 diabetes aged 2–70 and 34 with type 2 aged 18–70. Each system was used for four weeks, followed by a four-to-six-week Omnipod 6 extension with optional bolusing. The summary reports noninferiority for the primary glucose endpoints and no severe hypoglycemia, DKA or serious adverse events during either study phase. It provides no numerical endpoint tables or noninferiority margins, so it cannot establish a precise comparative benefit or exclude uncommon harms.1
The headline result has a narrower denominator. Insulet’s June announcement reports 77% versus 73% time in 70–180 mg/dL for the 33 participants with T1D aged 14–70, with Omnipod 6 versus Omnipod 5 targets of 100 versus 110 mg/dL. That is manufacturer-reported short-term evidence, not a whole-cohort estimate or a comparison at identical targets. Current enhanced US Omnipod 5 also offers 100 mg/dL with the required app update and compatible Pods. These results do not measure long-term pump failure or occlusion rates.35
Next evidence and access. The current STRIVE 2 registry lists recruiting status, estimated enrollment of 200, two 13-week crossover periods and primary completion estimated for 22 February 2027; no results are posted. That further study is distinct from the STRIVE results above. Insulet’s separate fully closed-loop type 2 programme targets 2028 and should not be treated as a promised Omnipod 6 launch feature. The Omnipod 6 AID record discusses algorithm evidence separately.42
Coming soon
ETA · 2027 manufacturer launch target; algorithm FDA-cleared, complete-system commercial access unconfirmed
- →Manufacturer target for Omnipod 6 launch; final system configuration and commercial access remain to be confirmed · 2027 target
- →STRIVE 2 further randomized crossover comparison; no results posted · primary completion estimated 22 February 2027
- →Separate fully closed-loop type 2 programme; not an established Omnipod 6 pump feature · 2028 manufacturer launch target
Sources
- [1]FDA K261461: Omnipod 6 algorithm clearance and 510(k) summary · Regulatory decision · 2026-06-29 — Clearance letter and summary pages 2–8. Software-only interoperable automated glycemic controller; separate pump and bolus-calculator components are described.
FDA. K261461 clearance letter and Omnipod 6 algorithm summary (29 June 2026), summary pages 2–8.
- [2]Insulet 2025 Investor Day: Omnipod 6 development roadmap · Manufacturer · 2025-11-20
Insulet. Investor Day roadmap (20 November 2025).
- [3]Insulet reports STRIVE results and separate fully closed-loop development · Manufacturer · 2026-06-06 — Manufacturer conference-results summary. Headline T1D outcomes refer to the 33 participants aged 14–70, not all 132 participants.
Insulet. STRIVE results announcement (6 June 2026).
- [4]STRIVE 2: Omnipod 6 versus Omnipod 5 (NCT07579702) · Trial registry · 2026-08-03 — Latest posted registry update checked 17 September 2026. No results posted; enrollment and future completion dates are estimates.
ClinicalTrials.gov. NCT07579702, last posted update 3 August 2026; checked 17 September 2026.
- [5]Enhanced Omnipod 5: 100 mg/dL target and compatible Pod requirements · Manufacturer
Insulet. Current enhanced Omnipod 5 algorithm FAQ.