Omnipod® 5 is the first tubeless automated insulin delivery (AID) system with smartphone control for the management of type 1 diabetes mellitus.
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.
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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.
People interested in Pod therapy can 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.
In June 2024, the company fully launched Omnipod 5 integrated with Dexcom G7 and released the Omnipod 5 app for iPhone in a limited market in the US. Omnipod® 5 is the sole insulin delivery system that connects with both Dexcom G6 and G7 sensors.
Omnipod 5 is also available in Germany, France and the UK.
Regulatory approvals for Omnipod 5
The US Food and Drug Administration (FDA) cleared the Omnipod 5 AID system for individuals aged six years and older with type 1 diabetes in January 2022. It expanded the clearance to include people aged two and older with type 1 diabetes in August 2022. The system also holds FDA breakthrough therapy designation.
In September 2022, Insulet received the CE mark under the European Medical Device Regulation for Omnipod 5 for individuals aged two years and above with type 1 diabetes.
The company received FDA 510(k) clearance for the Omnipod 5 app for iPhone in October 2023.
The company received CE [Conformité Européene] approval in Europe for the additional compatibility of the Abbott FreeStyle Libre 2 Plus sensor with Omnipod 5 for the condition in February 2024. The device is compatible with multiple CGM sensor brands.
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 the Omnipod 5 mobile app integrated with SmartBolus Calculator.
The pod fits firmly anywhere on the patient’s 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 the 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 Omnipop® 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 5 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 of 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% 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.
Additional clinical trials details
The SECURE-T2D pivotal trial assessed the impact of AID in adults with type 2 diabetes requiring insulin. Results showed that using Omnipod® 5 led to significant glycaemic improvements compared to prior treatments with insulin injections or pump therapy.
Key findings included notable reductions in HbA1c, time in hyperglycaemia and total daily insulin dose, along with a significant improvement in time in range without increasing time in hypoglycaemia.
The trial also demonstrated a clinically meaningful reduction in diabetes distress. Specifically, the mean HbA1c decreased from 8.2% to 7.4%, with participants who had a baseline HbA1c of greater than or equal to 9.0% experiencing a reduction of 2.1%.
