Study Findings: Time in Range Increase with 2,2 hours for Adults and 3,7 hours for Children with Omnipod® 5, fully on-body Automated Insulin Delivery System Future Insulet Product, Omnipod® 5
Study Results Presented at ENDO 2021 Congress
On March 20th, at the virtual ENDO 2021 Congress results from the Omnipod® 5 pivotal trials were presented. Nordic Infucare, distributor of Omnipod® solutions in the Nordic Markets, is pleased to support the cascade of the pivotal trial findings which are highly anticipated by the type 1 diabetes community.
Omnipod® 5 will be the first fully on body wearable system for Insulin delivery, consisting of an insulin filled pod directly communicating with a Dexcom G6® sensor.
Nordic Infucare CEO, Gonzague Dehen says, “We have a team of committed professionals who look
forward to the opportunities the Omnipod® system brings for those affected by type 1 diabetes. We are eager to keep making diabetes easier for patients and healthcare professionals in the Nordic markets.”
In the study children, from 6 years of age, and adults with type 1 diabetes showed significant improvements of Time in Range and Hba1c when using Omnipod® 5.
The study participants used Omnipod® 5 for 3 months after an initial 14-day period of standard therapy, consisting of the patient's previous insulin therapy. The results were presented in two groups, children 6-13,9 years of age, and adults 14-70 years.
Time in Range, glucose values between 3,9 -10 mmol/l increased from 53% to 68% in children and from 65% to 74 %. At the same time, Time Below Range, values under 3,9 mmol/l, stayed very low, 1,5% for children and 1,1% for the adult group.
Hba1c decreased in both study groups, with the largest reductions seen in those with a higher value from start. A remarkable 95 % of the study time with Omnipod® 5 was spent in automated mode, during which insulin delivery continuously adapts based on the users glucose levels and trends.
Quoting MD Jarl Hellman, Senior Consultant, Head of Diabetes, Uppsala University Hospital, Sweden
"This first pivotal study for the Omnipod® automated insulin delivery system with Dexcom G6 shows excellent improvement of the glycemic control with increased time in range combined with very low rates of hypoglycemia for both children, adolescents and adults. It shows that Omnipod 5 is a safe tubeless hybrid closed loop system that will make an important contribution to our ”diabetes tool box”.
About Omnipod® 5 Highlights
Omnipod® 5 is a commercially intended Automated Insulin Delivery System containing a tubeless insulin pump (Pod), an Omnipod® 5 application running on a handheld device and an interoperable Dexcom G6 CGM.
● The Pod is a lightweight, waterproof (IP28), self-adhesive insulin pump that delivers insulin through an automatically inserted cannula.
● The automated insulin delivery algorithm is built into the Pod, which receives glucose measurements every 5 min directly from the on-body CGM.
● The algorithm then commands the Pod to deliver microboluses every five minutes based on current and projected glucose values, with the goal of achieving and maintaining a set target glucose value.
● The user interacts with the system through the Omnipod® 5 app, which communicates with the Pod through Bluetooth wireless technology.
● Since the algorithm runs on the Pod, and the Pod and CGM are both worn on-body and communicate directly, automated insulin delivery can continue uninterrupted even if the handheld device containing the app is not nearby.
Forlenza et al, First Outpatient Evaluation of a Tubeless Automated Insulin Delivery System with Customizable Glucose Targets in Children and Adults with Type 1 Diabetes, DTT, Vol 23, Nr 6, 2021, Mary Ann Liebert, Inc.DOI: 10.1089/dia.2020.0546
Omnipod® 5 Automated Insulin Delivery System has been submitted to the FDA for approval and a US limited market release is expected to take place during the late first half of 2021.
All Omnipod® Insulin Delivery Systems are trademarks or registered trademarks and products of Insulet
Corporation. Omnipod® and Omnipod DASH® are CE-marked and EU-approved medical devices.
NordicInfu Care AB acts as distributor of Omnipod® Insulin Delivery Systems in the Nordic Markets.
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