US-based Insulet has unveiled positive results from a study investigating its Omnipod 5 system compared to insulin pump therapy with continuous glucose monitoring (CGM).

Insulet’s Omnipod 5 is a tubeless hybrid closed-loop system that delivers insulin doses automatically. The company said that data from the OP5-003 randomised controlled trial demonstrated its device led to improved glycaemic and patient-reported outcomes compared to traditional insulin pump therapy with CGM.

Patients with type 1 diabetes had a 17.5% improvement in ‘time within range’ – the window in which blood glucose levels are in a recommended target range. Users also exhibited a decreased percentage of time in hypoglycaemia, amongst other HbA1c parameters.

Insulet stated that the aim of the study (NCT05409131) was to evaluate the device in a real-world population, namely participants with an HbA1c above 8% at baseline.

194 participants were randomised into the two treatment groups and studied for over three months. All primary and secondary endpoints of the study were met.

Omnipod 5 was US Food and Drug Administration (FDA)-cleared and CE-marked in 2022. The device rolled out in the UK after authorisation in 2023.  

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By GlobalData

The loop system was exclusively used with DexCom’s G6 CGM until it gained FDA clearance and CE mark approval to be used with Abbott’s FreeStyle Libre 2 Plus sensor. The expanded compatibility increased the accessibility of the device to more diabetes patients.

The technology uses CGM data to predict glucose levels an hour ahead of time and corrects every five minutes based on individual glucose targets.

GlobalData analysis estimates that the global insulin pump device market will be worth $14.1bn by 2033. The CGM sensor market is forecast to grow to $5bn by the same year.

Insulet is a company that is quickly rising in the diabetes space. Currently, Medtronic and Abbott occupy the greatest market share of insulin pumps and CGMs, with a 20.5% and 19% share respectively. Dexcom has a 9.2% share, according to GlobalData.

The Omnipod 5 received another companion in October 2023, when Insulet received FDA clearance for an iPhone app used with the device. Already available on Android, the free app allows full control of the pump system via a compatible smartphone.

Hybrid closed-loop systems reached a milestone in the UK late last year when the National Institute of Health Care and Excellence (NICE) recommended that people living with type 1 diabetes should be offered the technology, opening accessibility to hundreds of thousands of patients.

The NHS in England and Wales will offer the devices to eligible patients in a phased programme over five years.


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