Skip to content
type1.science

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: . 16 September review-note archive (earlier notes may not cover later changes).

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. Review coverage and open work · How to read the evidence

Full sources ↓Full discussion ↓Report an issue →

On the horizonRegulator-approvedpumptubelesspatchphone-control

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
Read the reported benefits in the full discussion. Effect sizes and study limitations are described there.
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 16 September review-note archive and current review coverage for documented checks and their limits.

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.

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, but its final swimming limits, size, capacity and release configuration still need product documentation. Those unknowns should remain visible rather than inherit Omnipod 5 specifications.

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.34

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.52

References

  1. FDA. K261461 clearance letter and Omnipod 6 algorithm summary (29 June 2026), summary pages 2–8. https://www.accessdata.fda.gov/cdrh_docs/pdf26/K261461.pdf ↩ ↩2 ↩3 ↩4

  2. Insulet. Investor Day roadmap (20 November 2025). 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 ↩ ↩2 ↩3

  3. Insulet. STRIVE results announcement (6 June 2026). 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 ↩

  4. Insulet. Current enhanced Omnipod 5 algorithm FAQ. https://www.omnipod.com/hcp/algorithm-enhancement-faq ↩

  5. ClinicalTrials.gov. NCT07579702, last posted update 3 August 2026; checked 17 September 2026. https://clinicaltrials.gov/study/NCT07579702 ↩

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. [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.
  2. [2]Insulet 2025 Investor Day: Omnipod 6 development roadmap · Manufacturer · 2025-11-20
  3. [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.
  4. [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.
  5. [5]Enhanced Omnipod 5: 100 mg/dL target and compatible Pod requirements · Manufacturer