Insulet rolls out an updated Omnipod 5 algorithm and
Launch

Insulet rolls out an updated Omnipod 5 algorithm and FreeStyle Libre 3 Plus compatibility in the US

On June 3, 2026, Insulet announced the US rollout of an enhanced Omnipod 5 algorithm with a new 100 mg/dL Target Glucose option, cleared by the FDA in December 2025, and US compatibility with Abbott's FreeStyle Libre 3 Plus sensor.

Published

Event date

Key facts

Event date
Companies
Insulet Corporation, Abbott
Products
Omnipod 5 Automated Insulin Delivery (AID) System, Omnipod 5 algorithm, FreeStyle Libre 3 Plus Sensor
Status
US rollout announced June 3, 2026; algorithm cleared December 3, 2025
Primary source
Insulet Announces U.S. Rollout of Enhanced Omnipod 5 Algorithm and Expands Compatibility with Abbott's FreeStyle Libre 3 Plus Sensor

Full story

On June 3, 2026, Insulet announced that it was rolling out an enhanced algorithm for the Omnipod 5 Automated Insulin Delivery (AID) System to users in the US. The same release said Omnipod 5 was now compatible in the US with Abbott's FreeStyle Libre 3 Plus sensor, with caregivers able to follow along through an Abbott app.[1]

What changed in the algorithm

The headline change is a lower setting. Insulet said the updated algorithm adds a 100 mg/dL Target Glucose option, which gives healthcare providers six settings to choose from, between 100 and 150 mg/dL.[1] Insulet called the update the most significant change to the algorithm since Omnipod 5 launched in 2022, and said it applies to all US users, new and existing.[1]

The company also said the update helps users stay in Automated Mode with fewer interruptions, even during prolonged high glucose events.[1] The release summed up the alarm changes as "improved alarm handling" that helps users "stay in Automated Mode longer."[1]

The FDA clearance behind it

Insulet said the updates followed FDA 510(k) clearance in December 2025.[1] When we checked the FDA's 510(k) database, it listed a submission named "Omnipod 5 algorithm" from Insulet Corporation, number K251779. The FDA received it on June 10, 2025 and found it substantially equivalent on December 3, 2025.[2] The record files it under the device classification "Interoperable Automated Glycemic Controller," product code QJI, reviewed by the Clinical Chemistry panel.[2]

How the update reaches users

The new features did not arrive all at once. Insulet said Omnipod 5 users would receive an over-the-air software update through their Omnipod 5 Controller or mobile app. It added that access to new features would expand as compatible Pods became available.[1] To get the 100 mg/dL option to users sooner, Insulet said it began shipping compatible Pods into US retail channels ahead of the rollout.[1]

Libre 3 Plus compatibility

The second part of the announcement concerned sensors. Insulet said it was rolling out US compatibility between Omnipod 5 and Abbott's Libre 3 Plus sensor. Caregivers can follow patients through Abbott's LibreLinkup app, as the release spells it.[1] Insulet said additional international rollouts were planned for later in 2026, and that it would share more about the news at the American Diabetes Association's 86th Scientific Sessions, held June 5 to 8, 2026, in New Orleans.[1]

The release also restated who Omnipod 5 is cleared for in the US: people aged 2 and older with type 1 diabetes, and adults aged 18 and older with type 2 diabetes.[1] For the FreeStyle Libre systems, the release noted that the product is prescription only.[1]

What this means for you

Insulet said the algorithm update would reach existing US users over the air through the Omnipod 5 Controller or mobile app. It also said new features would become available as compatible Pods reach users.[1] Insulet described the six Target Glucose settings as a way for healthcare providers to fine-tune care.[1] Whether to change your target or move to a different sensor is a treatment question. Talk to your care team or pharmacist.

References

  1. Insulet Corporation. Insulet Announces U.S. Rollout of Enhanced Omnipod 5 Algorithm and Expands Compatibility with Abbott's FreeStyle Libre 3 Plus SensorSource
  2. U.S. Food and Drug Administration. 510(k) Premarket Notification K251779: Omnipod 5 algorithmSource