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4 March 2022

Insulet’s Omnipod 5 Automated Insulin Delivery System, US

Omnipod 5 is the first FDA-cleared tubeless automated insulin delivery (AID) system with smartphone control.
Omnipod® 5 is the first and only tubeless automated insulin delivery (AID) system in the US with compatible smartphone control. Credit: Business Wire.
Omnipod 5 was cleared by the US FDA in January 2022. Credit: Insulet Corporation.
The Omnipod® 5 System is intended for use by type 1 diabetics aged six years and above. Credit: Insulet Corporation.

Omnipod 5 is the first and only tubeless automated insulin delivery (AID) system with smartphone control for the management of type 1 diabetes mellitus in patients aged six years and older that is approved in the US.

The system integrates the Dexcom G6® continuous glucose monitoring (CGM) system to continuously deliver insulin for three days automatically, regulating insulin and preventing abrupt changes in glucose levels.

The Omnipod 5 AID system combines the precision and better user experience of the Dexcom G6® CGM with the ease of tubeless insulin administration, providing diabetics with a revolutionary new approach to glucose management, which does not involve multiple daily injections, tubes or fingersticks and optimises time in range.

The US Food and Drug Administration (FDA) cleared the Omnipod 5 AID system for human use in January 2022. The system also holds FDA’s breakthrough therapy designation.

People interested in Pod therapy can currently start a 30-day free Omnipod DASH® trial programme through OmnipodPromise™, and later upgrade to Omnipod 5 with a prescription directly to their pharmacist once it is ready and covered by insurance.

Details of Omnipod 5 AID system

The Omnipod 5 is a state-of-the-art AID system containing a small, wearable, waterproof and tubeless Pod with SmartAdjust™ technology, Dexcom G6® CGM, and Omnipod 5 mobile app integrated with SmartBolus Calculator.

The Pod fits firmly anywhere on the patients’ body and communicates wirelessly with the Dexcom® G6 CGM system.

The Dexcom® G6 CGM system delivers glucose readings to SmartAdjust™ every five minutes, allowing the Pod to automatically adjust insulin administration for up to three days, or 72 hours, and predict glucose levels for the next 60 minutes. The built-in SmartBolus Calculator incorporates the CGM data and trend of the patient automatically, preventing the need for manual updates.

The Omnipod 5 app takes complete control of the Pod. The user can either download the app onto a compatible personal smartphone or use the free Omnipod 5 Controller, which comes with the first prescription at no further cost.

Omnipod 5 SmartAdjust™ technology

The SmartAdjust™ technology integrated into the Pod proactively adjusts insulin administration based on the customised glucose target, which can range from 110mg/dl to 150mg/dl in 10mg/dl increments.

The system increases, decreases or pauses automatic insulin administration based on the user’s desired and customised glucose target. Users should always keep the controller or smartphone in a location where they can hear alerts or notifications from the Omnipod 5 app.

Benefits of the Omnipod 5 AID system

Omnipod is a one-of-a-kind, automated drug delivery system that improves adherence, outcomes and differentiation throughout the lifecycle of a drug.

The system offers smarter continuous drug delivery, as well as automated dosing within therapeutic windows. It offers competitive differentiation with improved convenience and adherence, as well as consistent and accurate dosage. It is designed to satisfy the specific requirements of an anti-diabetic drug.

It allows for the customisation of complicated dosing regimens and benefits payers through better therapeutic outcomes.

Clinical trial on Omnipod 5 AID system

The safety and effectiveness of Omnipod 5 AID system were studied in a multi-centre, 12-month clinical trial that enrolled type 1 diabetes patients aged between six and 70 years. The clinical trial included a three-month pivotal study, followed by an extension study.

The primary endpoints of the trial were changes in the blood glucose levels (HbA1c), time in range (TIR) (70-180mg/dl) and the occurrence of severe hypoglycaemia.

After the completion of the three-month pivotal trial, 95% of patients opted to continue the use of Omnipod 5 in the extension study.

In the pivotal trial, adults and adolescents achieved a decline in blood glucose from 7.2% to 6.8%, which was maintained post 12 months of use. TIR increased during the first three months of use from 63.6% to 73.8% and continued at 72.7% in months ten to 12 of use.

In children, blood glucose levels declined from 7.7% to 7.0% after using the system for three months, and the decline was maintained after 12 months of system use, with mean HbA1c remaining at 7.0%. TIR increased from 52.4% to 67.9% during the first three months of use and continued at 66.8% in months ten to 12 of use.

Omnipod 5 was found to be safe and effective when used in automatic mode at home for three months by adults, adolescents and children aged above six years.

The clinical study results showed a trifecta of clinical outcomes, including a reduction in HbA1c, improved TIR and a very low occurrence of hypoglycaemia.

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