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Omnipod 5 (SmartAdjust AID)

Insulet

The tubeless Omnipod 5 automated insulin delivery system — a waterproof, on-body Pod that runs the SmartAdjust algorithm itself and works with a choice of CGM (Dexcom G6/G7 or Abbott FreeStyle Libre 2 Plus/3 Plus). A 2026 enhanced algorithm adds an optional 100 mg/dL target and keeps users in Automated Mode through prolonged highs. Still a hybrid loop — you announce meals.

Available nowStrong evidencehybrid-closed-looptubelessphone-controlOfficial site ↗

The scorecard

Time in range75

Achieved, not just improved: the type 1 pivotal trial reached ~68% time-in-range in children and ~74% in adults, and a 353-person real-world type 1 cohort added +16 points on top of baseline — the same whether paired with Dexcom or Libre.[5]

Hypo protection74

Adults achieved ~1.1% time below 70 mg/dL in the pivotal trial (down from 2.0%), and severe-hypo events stayed rare across the two-year extension.[4]

Automation level66

Predicts glucose 60 min ahead and micro-doses every 5 min including auto-corrections; the 2026 enhanced algorithm keeps it auto-correcting through prolonged highs instead of dropping to Manual Mode — but meals are still announced, so it remains a hybrid loop.[2]

Freedom (form factor)92

Fully tubeless and waterproof: the entire system is one small on-body Pod with no tubing and no separate pump to clip, carry or disconnect — among the most discreet and mobile AID form factors available.

Average glucose72

Real-world type 1 HbA1c fell most in those starting highest (−3 mmol/mol overall, −7 mmol/mol if baseline ≥58), independent of which sensor was used.[5]

Low variability68

Continuous five-minute adjustment smooths day-to-day swings; large unannounced meals remain the main residual source of variability in a hybrid system.[6]

Exercise handling66

The Activity feature raises the target to 150 mg/dL for up to 24 h; an RCT showed it cuts insulin and softens exercise glucose drops, though it does not fully prevent lows.[8]

Customizability70

The glucose target is adjustable in 10 mg/dL steps, and the 2026 enhanced algorithm extends the range down to an optional 100 mg/dL (six settings, 100–150), plus the timed Activity target.[1]

Access & cost66

Pharmacy-channel availability in the US, UK and EU, and free CGM choice — including the lower-cost, factory-calibrated FreeStyle Libre sensors — that can widen access.[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 5 is a tubeless automated insulin delivery (AID) system: a single, waterproof Pod worn on the body holds the insulin and runs the control algorithm itself, paired with a continuous glucose monitor (CGM) of your choice. It is not tied to one sensor — in 2026 it works with Dexcom G6, Dexcom G7, Abbott's FreeStyle Libre 2 Plus and the newer FreeStyle Libre 3 Plus, so people can pick the CGM that suits their cost, form factor and preference without changing the pump, algorithm or app.12

Components

The system is three parts working as one: the tubeless Pod, which delivers insulin through an automatically inserted cannula and runs the control algorithm on-body; your chosen CGM, which streams glucose readings; and the SmartAdjust algorithm, which every 5 minutes takes a CGM value and trend, predicts where glucose will be 60 minutes ahead, and increases, decreases or pauses insulin toward your target.34 It is controlled by a compatible smartphone or the supplied Controller.2

The 2026 enhanced algorithm

In December 2025 the FDA cleared a major SmartAdjust update — the biggest since Omnipod 5 launched — which began rolling out in the US through 2026.56 Two changes matter most: an optional 100 mg/dL (5.6 mmol/L) glucose target, lowering the selectable range to six settings from 100 to 150 mg/dL; and fewer interruptions — a new advisory alarm lets the system keep auto-correcting every 5 minutes through prolonged high-glucose events instead of forcing a switch to Manual Mode.54 The same update added FreeStyle Libre 3 Plus as a sensor option in the US.4

Does the sensor change the results?

No. A real-world study of 353 adults that directly compared sensors found that the choice of CGM (Dexcom G6 vs FreeStyle Libre 2 Plus) slightly changed time spent in full automated mode (94% vs 96%) but did not change the likelihood of improving time-in-range or HbA1c — Omnipod 5 use was tied to a +16-point time-in-range gain regardless of sensor, greatest in those who started highest.7

Glycemic outcomes (achieved)

In the 3-month type 1 pivotal trial, time-in-range (70–180 mg/dL) reached ~68% in children and ~74% in adults; HbA1c fell 0.71% and 0.38% respectively; and adults cut time below 70 mg/dL from 2.0% to 1.1%.8 Two-year extension data showed these gains were maintained, with users in automated mode ~96% of the time.9

Automation level

This is a hybrid closed loop. It automates background insulin and delivers automatic correction micro-boluses for highs, but you still announce meals and count carbohydrates to bolus.3 It is not fully closed-loop — that step is reserved for the successor Omnipod 6.

Exercise

The Activity feature raises the target to 150 mg/dL for a chosen period up to 24 hours.10 In a randomized crossover trial, enabling it before exercise reduced insulin delivery and softened the glucose drop versus standard auto mode, though it did not eliminate hypoglycemia — so extra carbohydrate is still advised.11

Form factor

Omnipod 5's defining advantage is freedom: the whole system is one small, tubeless, waterproof Pod. There is no tubing to catch or kink and no separate pump body to clip, carry or disconnect for showering, swimming or sport — the most discreet and mobile form factor among mainstream AID systems.2

Ages, indications and access

Omnipod 5 is indicated from age 2 and available through the pharmacy channel in the US, UK and EU.2 Free CGM choice — including the lower-cost, factory-calibrated FreeStyle Libre sensors — is a practical access advantage.1

References

  1. Insulet (Omnipod). Omnipod 5 & CGM Sensor Integrations — compatible with Dexcom G6, Dexcom G7, FreeStyle Libre 2 Plus and FreeStyle Libre 3 Plus. https://www.omnipod.com/what-is-omnipod/omnipod-5/sensors ↩ ↩2

  2. Insulet Corporation. Omnipod 5 System is Now Compatible with Abbott's FreeStyle Libre 2 Plus Sensor in the U.S. (Nov 2024) — three sensor choices; pharmacy-channel availability; smartphone control. https://investors.insulet.com/news/news-details/2024/Insulet-Announces-Omnipod-5-System-is-Now-Compatible-with-Abbotts-FreeStyle-Libre-2-Plus-Sensor-in-the-U.S/default.aspx ↩ ↩2 ↩3 ↩4

  3. Insulet. Omnipod 5 FAQs: The Omnipod 5 Algorithm (SmartAdjust) — predicts glucose 60 minutes ahead and adjusts every 5 minutes. https://www.omnipod.com/current-podders/resources/omnipod-5/faqs/smartadjust-technology ↩ ↩2

  4. Insulet. Omnipod 5 Algorithm Enhancement & FreeStyle Libre 3 Plus Integration FAQs (HCPs) — SmartAdjust adjusts every 5 min (up to 12 autocorrections/hour); new Check Blood Glucose Advisory Alarm keeps users in Automated Mode during highs; adds Libre 3 Plus. https://www.omnipod.com/hcp/algorithm-enhancement-faq ↩ ↩2 ↩3

  5. Insulet Corporation. Insulet Announces FDA 510(k) Clearance of Omnipod 5 Algorithm Enhancements that Redefine Insulin Delivery and Simplify the Pod Experience — optional 100 mg/dL target; stays in Automated Mode through prolonged highs; US rollout first half of 2026 (announced Dec 4, 2025). https://investors.insulet.com/news/news-details/2025/Insulet-Announces-FDA-510k-Clearance-of-Omnipod-5-Algorithm-Enhancements-that-Redefine-Insulin-Delivery-and-Simplify-the-Pod-Experience/default.aspx ↩ ↩2

  6. Beyond Type 1. Insulet's Updated Omnipod 5 Algorithm Approved by FDA. https://beyondtype1.org/omnipod-5-improved-algorithm-fda/ ↩

  7. Stimson RH, et al. Impact of Omnipod 5 automated insulin delivery on continuous glucose monitoring metrics and predictors of improvement in time in range. Diabet Med (2025); 42(11):e70137. https://doi.org/10.1111/dme.70137 ↩

  8. Brown SA, et al. Multicenter Trial of a Tubeless, On-Body Automated Insulin Delivery System With Customizable Glycemic Targets in Pediatric and Adult Participants With Type 1 Diabetes. Diabetes Care (2021); 44(7):1630-1640. https://doi.org/10.2337/dc21-0172 ↩

  9. Criego AB, et al. Two Years with a Tubeless Automated Insulin Delivery System. Diabetes Technol Ther (2024); 26(1):11-23. https://doi.org/10.1089/dia.2023.0364 ↩

  10. Insulet. Optimizing the Omnipod 5 Activity Feature for Your Patients. https://www.omnipod.com/hcp/blog/tips-guidelines/activity-feature-tips ↩

  11. Turner LV, et al. Use of the Omnipod 5 Automated Insulin Delivery System Activity Feature Reduces Insulin Delivery and Attenuates the Drop in Glycemia Associated With Exercise in a Randomized Controlled Trial. Diabetes Care (2025); 48(9):1598-1606. https://doi.org/10.2337/dc25-0141 ↩

What's next for this

  • →Enhanced SmartAdjust algorithm — optional 100 mg/dL target and fewer alarm interruptions (stays in Automated Mode through prolonged highs) · FDA-cleared Dec 2025, US rollout 2026
  • →FreeStyle Libre 3 Plus compatibility added (US) · 2026
  • →Successor Omnipod 6 with an adaptive-learning algorithm and one universal Pod across Dexcom and Libre · targeted 2027

Sources

  1. [1]Insulet Announces FDA 510(k) Clearance of Omnipod 5 Algorithm Enhancements (optional 100 mg/dL target; stays in Automated Mode during prolonged highs; US rollout first half of 2026) · manufacturer · 2025-12-04
  2. [2]Omnipod 5 Algorithm Enhancement & FreeStyle Libre 3 Plus Integration FAQs (SmartAdjust adjusts insulin every 5 minutes; new Check Blood Glucose Advisory Alarm keeps users in Automated Mode) · manufacturer
  3. [3]Omnipod 5 & CGM Sensor Integrations — Dexcom G6, Dexcom G7, FreeStyle Libre 2 Plus and FreeStyle Libre 3 Plus · manufacturer
  4. [4]Brown SA, et al. Multicenter Trial of a Tubeless, On-Body Automated Insulin Delivery System With Customizable Glycemic Targets in Pediatric and Adult Participants With Type 1 Diabetes. Diabetes Care 2021;44(7):1630-1640 · peer-reviewed · 2021-07-01
  5. [5]Stimson RH, et al. Impact of Omnipod 5 automated insulin delivery on continuous glucose monitoring metrics in type 1 diabetes (real-world, n=353; +16 points time-in-range, sensor-independent). Diabet Med 2025;42(11):e70137 · peer-reviewed · 2025-09-01
  6. [6]Criego AB, et al. Two Years with a Tubeless Automated Insulin Delivery System. Diabetes Technol Ther 2024;26(1):11-23 · peer-reviewed · 2024-01-01
  7. [7]Insulet's Updated Omnipod 5 Algorithm Approved by FDA (Beyond Type 1) · news
  8. [8]Turner LV, et al. Use of the Omnipod 5 Activity Feature Reduces Insulin Delivery and Attenuates the Drop in Glycemia Associated With Exercise: a Randomized Controlled Trial. Diabetes Care 2025;48(9):1598-1606 · peer-reviewed · 2025-09-01