US base Insulet announced positive results from a study investigating the 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 automatically delivers insulin doses. The company said data from the OP5-003 randomized controlled trial demonstrated that its device led to improvements in blood glucose levels and patient-reported outcomes compared to traditional insulin pump therapy with CGM.
Type 1 diabetics had a 17.5% improvement in their “time in range,” which is the amount of time their blood sugar levels were within the recommended target range. Users also experienced a decrease in the percentage of time they were hypoglycemic, among other HbA1c parameters.
Insulet said the goal of the study (NCT05409131) was to evaluate the device in a real-world population, participants with an HbA1c above 8% at baseline.
194 participants were randomly assigned to two treatment groups and studied over three months. All primary and secondary endpoints of the study were met.
Omnipod 5 received US Food and Drug Administration (FDA) clearance and CE mark in 2022. The device was rolled out in the UK after approval in 2023.
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Loop system was used exclusively dexcomThe G6 CGM was used until it received FDA clearance and CE mark approval. abbotFreeStyle Libre 2 Plus sensor. Expanded compatibility makes the device available to more people with diabetes.
This technology uses CGM data to predict blood sugar levels one hour in advance and corrects every five minutes based on individual blood sugar goals.
The global insulin pump device market is estimated to be worth $14.1 billion by 2033, according to GlobalData analysis. The CGM sensor market is expected to grow to $5 billion by the same year.
Insulet is a fast-growing company in the diabetes space. the current, medtronic and Abbott have the largest market share for insulin pumps and CGMs, with 20.5% and 19% share, respectively. According to GlobalData, Dexcom’s share is 9.2%.
In October 2023, Omnipod 5 will be joined by another member. At this time, Insulet received FDA clearance for the iPhone app used on the device. Already available on Android, this free app gives you full control of your pump system via your compatible smartphone.
The hybrid closed-loop system reached a milestone in the UK late last year when NICE recommended the technology be made available to patients with type 1 diabetes, reaching hundreds of thousands of patients. Now you can.
The NHS in England and Wales will offer the device to eligible patients in a phased program over five years.
