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type1.science

Omnipod 5 (pump)

Insulet

What it is

A tubeless, single-use Pod holding up to 200 units of U-100 insulin for up to 72 hours, with SmartAdjust running on the Pod. The Pod is water-rated; the Controller is not waterproof. Indicated for type 1 diabetes from age 2, with country-specific sensor and control-device options. The enhanced US algorithm began rolling out in June 2026. Two lot-specific Class I FDA recalls in 2026 concern insulin leakage.

Editorial review: .

Most recent recorded citation dates: 2026-09-15; 2026-09-15. Some dates overlap at their stated precision or share the same date. 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

Full sources ↓Full discussion ↓Report an issue →

Available nowRegulator-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
Reliability: Mature on-body platform with occlusion detection and a large real-world record (~70,000 users), but 2026 exposed a real weakness: two separate Class I FDA recalls of specific Pod lots — a tear in the Pod's internal tubing (FDA Class I notice 29 Apr 2026) and a tear in the cannula just above the skin (FDA Class I notice 2 Jul 2026) — both causing insulin under-delivery that can happen without any alarm.[11]
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.

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.

Default calculation: 64 × 20 + 64 × 20 + 93 × 20 + 86 × 15 + 58 × 10 + 62 × 15 = 7220; divide by total weight 100. Unrounded weighted result: 72.2.

Interoperability64

Commercial Omnipod 5 supports its labelled CGM pairings. Separately, the Pod hardware is supported by released Loop 3.14.7 and Trio 1.0; these DIY controllers replace the commercial algorithm and are not Insulet-approved integrations.[14]

Reliability64

Mature on-body platform with occlusion detection and a large real-world record (~70,000 users), but 2026 exposed a real weakness: two separate Class I FDA recalls of specific Pod lots — a tear in the Pod's internal tubing (FDA Class I notice 29 Apr 2026) and a tear in the cannula just above the skin (FDA Class I notice 2 Jul 2026) — both causing insulin under-delivery that can happen without any alarm.[11]

Form factor93

The tubeless Pod is rated IP28 for up to 7.6 m for 60 min; the Controller is not waterproof. This supports on-body wear without external tubing, within each component's water limits.[7]

Phone control86

In the US, compatible iPhone and Android models can control Dexcom combinations. Libre 3 Plus works with the Controller or compatible Android models; Libre 2 Plus requires the Controller. Libre 3 Plus is not yet supported on iPhone. Other countries have different options.[8]

Capacity58

The disposable Pod holds up to 200 units of U-100 insulin and is replaced after up to 72 hours. Capacity and replacement frequency are documented specifications; the numeric capacity rating is editorial.[7]

Access & cost62

Marketed in the US, UK, Australia and selected European countries. US supply uses the pharmacy channel; this does not describe UK/EU funding or guarantee insurance coverage. The Pod is a recurring single-use supply.[15]

Editor’s take

Our editorial view: the tubeless, body-worn Pod is particularly useful when avoiding external tubing matters. Compatible phone control is a US option with sensor-specific limits; other users may need the Controller. Recurring Pod supplies and two lot-specific 2026 Class I recalls are practical considerations. Check lot numbers and follow the recall instructions; absence of an alarm does not rule out insulin under-delivery.

The full picture

Omnipod 5 puts the insulin reservoir, cannula and SmartAdjust algorithm in a disposable Pod worn directly on the body. It has no external insulin tubing. Whether that form factor is preferable is a personal choice; the water rating applies to the Pod, not the Controller.7

Form factor: a tubeless patch, not a tubed pump. There is no tubing and no separate insulin line — the Pod is a self-contained patch that sticks to the skin and is fully waterproof, rated IP28 for up to 25 feet (about 7.6 m) for 60 minutes, so the Pod can stay attached for showering and swimming within those limits. The Controller is not waterproof, and the selected CGM has its own water limits.17 Insulin is delivered through a small flexible cannula inserted automatically when the Pod is first activated, rather than by a hand-pushed infusion set.9

Reservoir and wear. Each Pod holds up to 200 units of U-100 rapid-acting insulin; the technical guide specifies an 85-unit minimum fill. It is worn for up to 72 hours and replaced as a whole single-use unit. The current US safety information lists NovoLog, Humalog, Admelog and Kirsty for use with Omnipod 5. Use the insulin brands and replacement instructions in the labeling for your own country.7209

Occlusion detection and reliability. The system has a blockage hazard alarm, but an absence of alarms does not rule out under-delivery. A retrospective analysis included 69,902 US users with type 1 diabetes and at least 90 days of qualifying data; among the 37,640 users with an average 110 mg/dL (6.1 mmol/L) target, median TIR was 68.8%. This was an observational subgroup, not a randomized comparison of target settings, and 110 mg/dL was the lowest available target in that historical dataset. One DKA event associated with infusion-site failure occurred in the original pivotal trial.9422

Recalls you should know about (2026). Omnipod Pods were the subject of two separate Class I FDA recalls in 2026 — Class I is the FDA's most serious category, used when a defect can cause serious injury or death. They are different defects, both lot-specific, and neither means every Pod is affected.

  • Internal tubing tear (Class I status confirmed in the FDA communication on 29 April 2026). Pods from certain lots could develop a tear in the Pod's internal tubing, so insulin leaks inside the Pod instead of reaching the body. Insulet wrote to affected customers on 12 March 2026 and the FDA issued an Early Alert on 18 March. This one affected Omnipod 5 Pods. As of 17 April 2026, Insulet had reported 29 serious injuries and no deaths.12
  • Cannula tear above the skin (Class I status confirmed in the FDA communication on 2 July 2026). A manufacturing fault can leave a small tear in the cannula — the soft tube that goes into you — just above the skin, so insulin leaks outside the body rather than being delivered. Insulet began a voluntary Medical Device Correction on 26 May 2026 covering specific lots of Omnipod 5, Omnipod DASH and Omnipod (Eros) Pods: roughly 7 million Pods, about 8.5% of 2025 global production, of which Insulet estimates around 60% had already been used or had expired. The FDA issued an Early Alert on 4 June and confirmed Class I status on 2 July 2026. As of 20 May 2026, Insulet had reported 24 serious injuries — high blood glucose including hospitalisation and diabetic ketoacidosis — and no deaths.1113

Both defects can cause insulin under-delivery without an alarm. Wetness or an insulin smell may occur, but the problem can go unnoticed. FDA instructions say to stop using affected Pods immediately, replace any active affected Pod with one from an unaffected lot, and contact the healthcare team about alternative insulin delivery if supplies run out. Check lot numbers with Insulet and request replacement Pods. For unexplained high glucose, follow the system instructions and your clinical sick-day plan.111213

Which CGMs and algorithms it works with. SmartAdjust runs inside the Pod, predicts glucose up to 60 minutes ahead and adjusts insulin every five minutes. The current US compatibility list includes Dexcom G6/G7 systems and FreeStyle Libre 2 Plus/3 Plus with specific compatible Pods and control devices. Sensor brands are not interchangeable across all Pod variants. Separately, the official Loop 3.14.7 and Trio 1.0 releases support Omnipod 5 hardware; these are independent DIY controllers, not Insulet-approved SmartAdjust integrations.7818149

Phone bolusing. In the US, compatible iPhone and Android models can deliver boluses and change settings with Dexcom sensor combinations. Libre 3 Plus supports the Controller or compatible Android models, while Libre 2 Plus requires the Controller. Libre 3 Plus is not currently supported by the iPhone app. The UK and Australian product pages describe the dedicated Controller; do not assume US phone options apply elsewhere.81617

Access by region. Current US labeling includes type 1 diabetes from age 2 and type 2 diabetes from age 18; SmartAdjust should not be used by people needing less than 5 units of insulin daily. US supply uses the pharmacy channel, subject to prescription and coverage. The product is also marketed in the UK, Australia and selected European countries, with country-specific compatibility and access arrangements. Availability does not establish local reimbursement or stock.197161715

The enhanced algorithm has now shipped. The FDA cleared the enhanced Omnipod 5 algorithm on 3 December 2025,21 and on 3 June 2026 Insulet announced its US rollout — an over-the-air software update delivered through the Omnipod 5 Controller or phone app, with both the app update and compatible Pods required. An app update alone does not upgrade older Pods.19 It adds a 100 mg/dL (5.6 mmol/L) target glucose option, giving six settings from 100 to 150 mg/dL (5.6–8.3 mmol/L), and improves alarm handling so people stay in Automated Mode with fewer interruptions, including during prolonged high glucose events.10 The same announcement confirmed US compatibility with Abbott's FreeStyle Libre 3 Plus sensor.10

Type 2 evidence is separate. US labeling also covers adults with type 2 diabetes. An early single-arm study in 24 adults reported an HbA1c reduction of 1.3 percentage points after eight weeks of AID; that is a type 2 study result and is not used as type 1 evidence here.1923

What's next for this

  • →Insulet continues development of wider CGM and control-device compatibility; use current local compatibility lists for available combinations.

Sources

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    Real-World Evidence of Omnipod 5 Automated Insulin Delivery System Use in 69,902 People with Type 1 Diabetes · Peer-reviewed study · 2024-02-16

    Forlenza GP, DeSalvo DJ, Aleppo G, et al. Real-World Evidence of Omnipod 5 Automated Insulin Delivery System Use in 69,902 People with Type 1 Diabetes. Diabetes Technology & Therapeutics (2024); 26(8):514–525. PMID 38375861.

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    Simplify Life with Omnipod 5 — product overview and specifications · Manufacturer

    Insulet (Omnipod). Simplify Life with Omnipod 5 — product overview (tubeless waterproof Pod, IP28 to 25 ft/60 min, up to 200 U U-100 insulin, ~72 h wear, on-Pod SmartAdjust, compatible insulins).

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    Omnipod 5 Smartphone & CGM Device Compatibility · Manufacturer

    Insulet. US Omnipod 5 smartphone and sensor compatibility table.

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    Omnipod 5 Important Safety Information (warnings and precautions) · Manufacturer

    Insulet. Important Safety Information, Omnipod 5 warnings and precautions.

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    Insulet Announces U.S. Rollout of Enhanced Omnipod 5 Algorithm and Expands Compatibility with Abbott's FreeStyle Libre 3 Plus Sensor · Manufacturer · 2026-06-03

    Insulet Corporation. Insulet Announces U.S. Rollout of Enhanced Omnipod 5 Algorithm and Expands Compatibility with Abbott's FreeStyle Libre 3 Plus Sensor (Jun 3, 2026; FDA 510(k) clearance December 2025; new 100 mg/dL target option, six settings 100–150 mg/dL; fewer interruptions during prolonged highs; over-the-air update via Controller or app; US Libre 3 Plus compatibility).

  11. [11]
    Insulin Pump Recall: Insulet Removes Omnipod Pods (Class I) · Regulatory decision · 2026-07-02 — Cannula tear just above the skin; affects Omnipod 5, Omnipod DASH and Omnipod (Eros) Pods from specific lots.

    US Food & Drug Administration. Insulin Pump Recall: Insulet Removes Omnipod Pods (Early Alert Jun 4, 2026; Class I status confirmed in FDA communication Jul 2, 2026; cannula tear just above the skin; "may happen without triggering any alert"; affects Omnipod 5, Omnipod DASH and Omnipod (Eros) Pods from specific lots; 24 serious injuries and no deaths as of May 20, 2026).

  12. [12]
    Insulin Pump Recall: Insulet Removes Certain Omnipod 5 Pods (Class I) · Regulatory decision · 2026-04-29 — Earlier, separate defect — a tear in the Pod's internal tubing.

    US Food & Drug Administration. Insulin Pump Recall: Insulet Removes Certain Omnipod 5 Pods (customer letter Mar 12, 2026; Early Alert Mar 18, 2026; Class I status confirmed in FDA communication Apr 29, 2026; tear in the Pod's internal tubing; 29 serious injuries and no deaths as of Apr 17, 2026).

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    Insulet Initiates Voluntary Medical Device Correction for Certain Omnipod Pods in the U.S. and Affected International Markets · Manufacturer · 2026-05-26

    Insulet Corporation. Insulet Initiates Voluntary Medical Device Correction for Certain Omnipod Pods in the U.S. and Affected International Markets (May 26, 2026; ~7 million Pods, ~8.5% of 2025 global production, ~60% already used or expired; leak "may be difficult to detect and go unnoticed"; free replacement of affected lots).

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    Trio v1.0 official compatibility release · Open-source community · 2026-09-15

    Trio maintainers. v1.0 release notes.

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    Insulet 2025 Form 10-K: Omnipod 5 markets and US pharmacy model · Manufacturer

    Insulet. 2025 Form 10-K, Omnipod 5 and Overview sections.

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    Omnipod 5 UK product information · Manufacturer

    Insulet. UK Omnipod 5 product information.

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    Omnipod 5 Australian product information · Manufacturer

    Insulet. Omnipod 5 component water specifications: Pod IP28, 7.6 m/60 min; Controller not waterproof.

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    Loop v3.14.7 official release notes · Open-source community · 2026-09-15

    Loop maintainers. v3.14.7 release notes, 15 September 2026.

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    Omnipod 5 US algorithm enhancement and sensor compatibility FAQ · Manufacturer

    Insulet. Omnipod 5 enhanced-algorithm FAQ: compatible Pods and updated app required.

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    Omnipod 5 UK technical user guide (24-02), minimum Pod fill · Manufacturer

    Insulet. Omnipod 5 UK technical user guide (24-02), Introduction and Pod filling instructions.

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    FDA K251779: Omnipod 5 algorithm clearance and 510(k) summary · Regulatory decision · 2025-12-03

    FDA. K251779 clearance letter (3 December 2025) and 510(k) summary, pages 4–10: indications, target range and in-silico validation.

  22. [22]

    Brown SA, Forlenza GP, Bode BW, 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. According to PubMed. https://pmc.ncbi.nlm.nih.gov/articles/PMC8323171/ (DOI)

  23. [23]

    Davis GM, Peters AL, Bode BW, et al. Safety and Efficacy of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 2 Diabetes: From Injections to Hybrid Closed-Loop Therapy. Diabetes Care (2023); 46(4):742–750. According to PubMed. https://pmc.ncbi.nlm.nih.gov/articles/PMC10090930/ (DOI)