Skip to content
type1.science
N/A (device / behavioral)CompletedNCT06865989

STRIVE: Omnipod 5 SmartAdjust 2.0 versus Omnipod 5

Insulet's pivotal crossover trial of SmartAdjust 2.0 — the algorithm behind the next Omnipod. 132 existing Omnipod 5 users, aged 2 to 70, spent four weeks on each system. Then everyone moved to a final period on SmartAdjust 2.0 in which they were asked to bolus no more than three times a day, probing how far the algorithm can go without being told about food. The trial completed in November 2025 and Insulet presented topline results at ADA in June 2026; the reduced-bolus period has not been reported.

Primary endpoints

  • Non-inferiority to Omnipod 5 at the end of period 2 on time below 54 mg/dL (3.0 mmol/L), margin 0.75 percentage points
  • Non-inferiority on time below 70 mg/dL (3.9 mmol/L), margin 3.0 percentage points
  • Non-inferiority on time in range 70-180 mg/dL (3.9-10.0 mmol/L), margin 3.0 percentage points
  • Non-inferiority on mean sensor glucose, margin 8 mg/dL (0.4 mmol/L)

Results so far

The trial completed on 10 November 2025. No results are posted on the ClinicalTrials.gov registry. Insulet presented topline data at the ADA Scientific Sessions in June 2026: in the type 1 arm (ages 14 and over), SmartAdjust 2.0 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%, with up to 50% more automated insulin delivered and no cases of DKA or severe hypoglycemia. A type 2 subanalysis reported in July 2026 showed 76% versus 73% time in range. These are company-reported conference figures, not a peer-reviewed publication — and nothing has been reported from period 3, the reduced-bolus period, which is the most interesting part of the design.

The full picture

STRIVE is the trial that decides whether the next Omnipod is actually better than the current one. Insulet took 132 people who already wear an Omnipod 5 — children as young as two, adults up to seventy — and had them run the investigational SmartAdjust 2.0 algorithm for four weeks and their existing Omnipod 5 for four weeks, in randomized order. SmartAdjust 2.0 is the software that becomes Omnipod 6: the same tubeless Pod, a new adaptive-learning algorithm, a lower glucose target.1

Who could take part. You had to already be an Omnipod 5 user on U-100 insulin, and to have spent most of the preceding fortnight at the system's tightest 110 mg/dL (6.1 mmol/L) target — so this is a trial of experienced, well-controlled pod users, not of people starting automation for the first time. Adults could enrol with either type 1 or type 2 diabetes; children were type 1 only.1

What "success" meant. Notably, STRIVE was designed as a non-inferiority trial on its four co-primary endpoints, all measured at the end of the second four-week period: time below 54 mg/dL (3.0 mmol/L), time below 70 mg/dL (3.9 mmol/L), time in range 70-180 mg/dL (3.9-10.0 mmol/L), and mean glucose. The margins were pre-specified and tight — 0.75 percentage points for time below 54, 3.0 points for time below 70 and for time in range, and 8 mg/dL (0.4 mmol/L) for mean glucose.1 In plain terms: the bar Insulet had to clear was do no harm, not do better. Any improvement on top of that is a bonus.

The third period is the interesting one

After the crossover, everyone spent a further four to six weeks on SmartAdjust 2.0 with one instruction: take no more than three meal or snack boluses a day.1 That is not a normal hybrid-closed-loop protocol. It is a deliberate test of how much of the meal work the algorithm can absorb on its own — the same question the CLOSE IT trial asked of the open-source community's algorithm, and the question that stands between every system sold today and a system that just runs.

It is worth being precise about what this is and is not. Reduced bolusing is not no bolusing. Omnipod 6 remains a hybrid closed loop for people with type 1 — you still announce meals — and Insulet's genuinely fully-closed-loop programme is a separate, type 2 programme. Period 3 is best read as a stress test of the algorithm's meal-handling headroom, not as the launch of a no-carb-counting Omnipod.

What is known, and what is not

The trial completed on 10 November 2025, and no results are posted on the registry.1 What exists is company-reported: at the ADA Scientific Sessions in June 2026 Insulet said that in the type 1 arm (ages 14 and over), SmartAdjust 2.0 delivered 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%, with up to 50% more automated insulin and no DKA or severe hypoglycemia.2 A type 2 subanalysis reported in July 2026 showed 76% versus 73% time in range and a drop in daily boluses.3

Three honest caveats.

First, these are conference and press-release numbers, not a peer-reviewed paper. They come from the sponsor, they have not been through review, and the full safety and per-age-group breakdowns are not public. Treat the four-point time-in-range gain as promising and provisional.

Second, the headline figures cover the type 1 arm aged 14 and over. The trial enrolled children from age two, but no separate young-children result has been reported — and young children are where AID algorithms are hardest to get right.

Third — and this is the gap that matters most — nothing has been reported from period 3. The reduced-bolus period is the part of STRIVE that speaks to the two roadmap gaps this trial bears on: an algorithm that does not know what you ate (missing context) and an algorithm smart enough to react anyway (algorithm intelligence). Until Insulet publishes it, we know that SmartAdjust 2.0 beats Omnipod 5 when you bolus normally, and we know nothing at all about how it copes when you mostly do not.

The confirmatory study, STRIVE 2, is now recruiting, with primary completion targeted for February 2027.

References

  1. ClinicalTrials.gov. STRIVE — Safety and Efficacy of the Omnipod SmartAdjust 2.0 System Compared to the Omnipod 5 System (NCT06865989). Randomized crossover, n=132, ages 2-70; start 26 Mar 2025, completed 10 Nov 2025; four co-primary non-inferiority endpoints at end of period 2; period 3 (4-6 weeks) on SmartAdjust 2.0 with a goal of no more than three meal or snack boluses per day. No results posted. https://clinicaltrials.gov/study/NCT06865989 ↩ ↩2 ↩3 ↩4 ↩5

  2. 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 or severe hypoglycemia (ADA 86th Scientific Sessions, 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 ↩

  3. Healio. Next-generation Omnipod 6 improves time in range over Omnipod 5 in type 2 diabetes — STRIVE type 2 subanalysis (7 July 2026): time in range 76% vs 73%, boluses 3.7 to 2.5 per 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 ↩