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type1.science

Omnipod 6 (AID)

Insulet

Insulet's next-generation tubeless AID, targeted for 2027 as the Omnipod 5 successor. It keeps the tubeless Pod but adds an adaptive-learning algorithm, a lower 100 mg/dL (5.6 mmol/L) target, and one "universal" Pod that works across Dexcom and FreeStyle Libre sensors. In the STRIVE pivotal trial its type 1 arm reached 77% time-in-range vs 73% on Omnipod 5. Still a hybrid loop — you announce meals. Not yet FDA-cleared.

On the horizonEarly evidencehybrid-closed-looptubelessphone-controlOfficial site ↗

The scorecard

Time in range78

In the STRIVE pivotal trial's type 1 arm (ages ≥14), Omnipod 6 reached 77% time-in-range versus 73% on Omnipod 5, and 54% time-in-tight-range (70–140 mg/dL / 3.9–7.8 mmol/L) versus 47% — achieved levels, head-to-head, but pre-market.[2]

Hypo protection76

Non-inferior hypoglycemia versus Omnipod 5 with no cases of DKA or severe hypoglycemia in the pivotal trial, while delivering more automated insulin — though it has no real-world track record yet.[2]

Automation level72

A new adaptive-learning algorithm learns each user's insulin needs and delivered up to 50% more automated insulin at a lower 100 mg/dL (5.6 mmol/L) target; still a hybrid loop, so meals are announced.[3]

Freedom (form factor)92

Keeps the fully tubeless, waterproof on-body Pod — the same shape and size as Omnipod 5 — so it retains the category's defining no-tubing, no-pump-body mobility.[4]

Average glucose76

The lower 100 mg/dL (5.6 mmol/L) target plus up to 50% more automated insulin drove higher time-in-tight-range (54% vs 47%), pointing to lower mean glucose — pending real-world confirmation.[2]

Low variability72

Adaptive learning and a universal Pod are designed to smooth delivery, but as a pre-market hybrid loop the variability ceiling set by announced meals and injected-insulin speed still applies.[4]

Exercise handling66

Expected to carry over Omnipod 5's timed Activity target for exercise; detailed activity behavior is not yet published.[4]

Customizability70

Adds the lower 100 mg/dL (5.6 mmol/L) target and one universal Pod across Dexcom and FreeStyle Libre, broadening CGM choice from a single device.[4]

Access & cost40

Not available anywhere: a 510(k) filing is planned and a 2027 US launch is targeted, so regional rollout, age clearances and Pod pricing are all unconfirmed.[3]

Glycemic criteria are scored on the levels actually achieved in large real-world Type 1 diabetes cohorts — not the headline improvement over a trial's baseline (an improvement that looks bigger when the starting population was doing poorly). Type 2 diabetes trial data is never used to score a Type 1 system; where only improvement data exists, it informs the rationale, not the score. Freedom captures form factor and wearability, so a tubeless system is rewarded for the mobility a tubed one can't match.

The full picture

Omnipod 6 is the next-generation tubeless automated insulin delivery (AID) system on Insulet's public roadmap, intended to launch in 2027 as the successor to Omnipod 5.1 It is not yet approved or on sale anywhere — everything below is drawn from Insulet's stated plans and the STRIVE pivotal trial, and the specifics could change before clearance.1

What changes

The Pod stays tubeless and waterproof — reportedly the same shape and size as Omnipod 5 — so the defining "no tubing, no separate pump body" freedom carries over unchanged.2 The upgrade is concentrated in software and connectivity: a new adaptive-learning algorithm that learns each user's insulin needs, a lower 100 mg/dL (5.6 mmol/L) target, and a single "universal" Pod designed to work across Dexcom and FreeStyle Libre sensors instead of separately manufactured CGM-specific Pods.12 It remains a hybrid loop — you still announce meals.1

Pivotal evidence (type 1 arm)

The pivotal STRIVE trial (NCT06865989) randomized 132 participants — 98 with type 1 and 34 with type 2 diabetes, ages 2–70 — to Omnipod 6 at a 100 mg/dL (5.6 mmol/L) target versus Omnipod 5.3 In the type 1 cohort aged 14 and older, Omnipod 6 raised time-in-range (70–180 mg/dL / 3.9–10.0 mmol/L) to 77% versus 73% on Omnipod 5, and time-in-tight-range (70–140 mg/dL / 3.9–7.8 mmol/L) to 54% versus 47%, while delivering up to 50% more automated insulin with no cases of DKA or severe hypoglycemia.4 These figures come from Insulet's own conference release, not a peer-reviewed publication — treat them as promising but provisional.4 A larger confirmatory trial, STRIVE 2 (NCT07579702, n=200), is recruiting with primary completion targeted for February 2027.5

A separate type 2 diabetes subanalysis of STRIVE was reported in July 2026 (time-in-range 76% vs 73%, time-in-tight-range 48% vs 43%, non-inferior for time in hypoglycemia, with daily boluses falling from 3.7 to 2.5).6 It is listed here only for completeness: type 2 results say nothing about how the system performs in type 1, and none of the scores on this page draw on them.

Access

The device is investigational: Insulet plans a 510(k) submission and is targeting a 2027 US launch.1 Regional rollout beyond the US, age clearances, and per-Pod pricing are all unconfirmed. The bigger Omnipod hardware redesign — more insulin, longer wear, and eventually a fully closed loop — is described as a later step beyond 2028.2

The fully closed-loop programme is a type 2 programme

Insulet also talks about a fully closed-loop system — no meal announcements at all — and it is easy to read that as the next step for Omnipod. It is not. That is a separate programme aimed at type 2 diabetes: the EVOLUTION 3 feasibility study presented at ADA 2026 was run in adults with type 2 diabetes, and the EVOLVE pivotal (running under an FDA IDE) is a type 2 study, with an FDA filing targeted for 2027 and a 2028 launch.74 Insulet has not announced a fully closed-loop programme for type 1. For people with type 1, Omnipod 6 remains a hybrid loop: you still announce meals.1

References

  1. Park A (MedTech Dive). Insulet unveils plans for new diabetes devices — Omnipod 6 hybrid closed-loop, 2027 launch, adaptive-learning algorithm, universal Pod connecting with all major CGMs. https://www.medtechdive.com/news/insulet-patch-pump-plans/806292/ ↩ ↩2 ↩3 ↩4 ↩5 ↩6

  2. Diabetech. Omnipod 6 Is Coming in 2027 — Here's Everything We Know — one universal Pod for Dexcom/Libre/future CGMs, lower 100 mg/dL target, same tubeless shape and size; larger redesign planned beyond 2028. https://www.diabetech.info/p/omnipod-6-is-coming-in-2027-here-s-everything-we-know ↩ ↩2 ↩3

  3. ClinicalTrials.gov. STRIVE — Omnipod SmartAdjust 2.0 System Compared to the Omnipod 5 System (NCT06865989; completed; n=132, 98 type 1 and 34 type 2, ages 2–70). https://clinicaltrials.gov/study/NCT06865989 ↩

  4. Insulet Corporation. Insulet Reveals New Data Supporting Breakthrough Omnipod 6 and Fully Closed-Loop AID Systems — type 1 arm (≥14 y): time-in-range 77% vs 73%, time-in-tight-range 54% vs 47%, up to 50% more automated insulin, no DKA/severe hypoglycemia (ADA 86th Scientific Sessions, June 6, 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 ↩ ↩2 ↩3

  5. ClinicalTrials.gov. STRIVE 2 — Efficacy of the Omnipod 6 System Compared With the Omnipod 5 System (NCT07579702; recruiting; n=200; primary completion Feb 2027). https://clinicaltrials.gov/study/NCT07579702 ↩

  6. Healio. Next-generation Omnipod 6 improves time in range over Omnipod 5 in type 2 diabetes — STRIVE type 2 subanalysis (July 7, 2026): time-in-range 76% vs 73%, time-in-tight-range 48% vs 43%, non-inferior for time in hypoglycemia, boluses 3.7 → 2.5/day. Type 2 data — not type 1 evidence. https://www.healio.com/news/endocrinology/20260707/nextgeneration-omnipod-6-improves-time-in-range-over-omnipod-5-in-type-2-diabetes ↩

  7. Drug Delivery Business. The biggest diabetes tech news out of ADA 2026 — Insulet's STRIVE and EVOLUTION 3 data; fully closed-loop system targeted for 2028; EVOLVE FDA IDE study initiated. https://www.drugdeliverybusiness.com/biggest-diabetes-tech-news-ada-2026/ ↩

Coming soon

ETA · 510(k) filing planned; targeted 2027 US launch (not yet FDA-cleared)

  • →US launch as the Omnipod 5 successor — adaptive-learning algorithm, 100 mg/dL (5.6 mmol/L) target, one universal Pod across Dexcom and FreeStyle Libre · targeted 2027
  • →STRIVE 2 confirmatory trial (NCT07579702, n=200) reads out · primary completion Feb 2027
  • →Insulet's fully closed-loop system — a separate programme aimed at type 2 diabetes: EVOLUTION 3 feasibility data presented at ADA 2026, EVOLVE FDA IDE pivotal now under way · FDA filing targeted 2027, launch 2028
  • →Larger Omnipod hardware redesign — more insulin capacity, longer wear, fully closed loop · beyond 2028

Sources

  1. [1]STRIVE — Omnipod SmartAdjust 2.0 (Omnipod 6) System Compared to the Omnipod 5 System (NCT06865989; completed; n=132 — 98 type 1, 34 type 2; ages 2–70) · registry
  2. [2]Insulet Reveals New Data Supporting Breakthrough Omnipod 6 and Fully Closed-Loop AID Systems (type 1 arm ≥14 y: time-in-range 77% vs 73%, time-in-tight-range 54% vs 47%, up to 50% more automated insulin, no DKA/severe hypoglycemia; ADA 86th Scientific Sessions, June 6, 2026) · manufacturer · 2026-06-06
  3. [3]Insulet unveils plans for new diabetes devices (Omnipod 6 hybrid closed-loop, 2027 launch, adaptive-learning algorithm, universal Pod across all major CGMs) — MedTech Dive · news · 2025-11-21
  4. [4]Omnipod 6 Is Coming in 2027 — Here's Everything We Know (one universal Pod for Dexcom and Libre, 100 mg/dL target, same tubeless shape/size, ~200-unit reservoir, ~3-day wear) — Diabetech · news
  5. [5]STRIVE 2 — Efficacy of the Omnipod 6 System Compared With the Omnipod 5 System (NCT07579702; recruiting; n=200; 13 weeks; primary completion Feb 2027) · registry
  6. [6]Next-generation Omnipod 6 improves time in range over Omnipod 5 in type 2 diabetes — STRIVE type 2 subanalysis (time-in-range 76% vs 73%, time-in-tight-range 48% vs 43%, non-inferior for hypoglycemia, boluses 3.7 → 2.5/day) — Healio · news · 2026-07-07 — Type 2 diabetes data — not used to characterize type 1 performance.
  7. [7]The biggest diabetes tech news out of ADA 2026 (Insulet: STRIVE and EVOLUTION 3; fully closed-loop system targeted 2028; EVOLVE FDA IDE study initiated) — Drug Delivery Business · news