Omnipod 5: first tubeless automated insulin delivery system approved by Health Canada! – BETTER (2024)

For many people living with type 1 diabetes (T1D), the wait for the groundbreaking news is finally over. Health Canada has officially approved the Omnipod 5 hybrid closed-loop insulin delivery system- the first of its kind wearable, on-body, tubeless ‘artificial pancreas‘ designed for individuals aged 2 and older living with T1D.

While this approval marks a significant milestone, it’s just the beginning of bringing this groundbreaking technology to the market. Patients will need to wait a little longer to get their hands on the Omnipod 5 system- a revolutionary combination of a continuous glucose monitoring system (CGM) and an insulin pump, seamlessly communicating through software and an app for automated insulin delivery. Insulet Corporation, the manufacturer, must satisfy Health Canada’s requirements, including demonstrating sufficient stock availability for future users. Additionally, they’re tasked with developing a training and integration program tailored for healthcare professionals and individuals living with T1D in Canada.

The Omnipod 5 system features

The Omnipod 5 system consists of a pod incorporating an algorithm (a sequence of calculations expressed in the form of software), the Dexcom G6 continuous glucose monitoring system and the Omnipod 5 App, all connected by Bluetooth.

• The pod, serving as a tubeless insulin pump stuck to the skin, contains insulin and a motor that facilitates its delivery through a small, flexible tube called a cannula. It requires replacement every 3 days.
• The Smart Adjust algorithm: contained within the pod, this algorithm automatically adjusts insulin dosing based on blood glucose readings received from the Dexcom G6 sensor. For example, by analyzing current and trending glucose levels, basal rates, and active insulin (insulin circulating in the body, still working to lower blood glucose levels), it adjusts insulin delivery every 5 minutes, minimizing the risk of hypo- or hyperglycemia.
• The CGM: currently, the Omnipod 5 system is designed to work only with the Dexcom G6 continuous glucose monitoring system. Notably, it’s important to mention that the Dexcom receiver (which some people use instead of a cell phone) does not work with Omnipod 5.
• The Omnipod 5 App can be downloaded to a compatible smartphone or in the dedicated Controller, provided at no additional cost with your first prescription. Currently, it’s not clear whether the Health Canada-approved app is compatible with Android, Apple or both. The app empowers users to customize basal profiles, set target glucose levels, adjust bolus settings, manage pod activation and deactivation, and seamlessly switch between automatic and manual modes.

As with other commercial hybrid closed-loop systems currently available in Canada, the Omnipod 5 system does not offer fully automated insulin delivery. Users still must manually input carbohydrate intake into the Omnipod 5 application, enabling the algorithm to compute the necessary insulin dosage to manage meals effectively. Additionally, users may need to adjust settings or parameters, such as activating the physical activity mode, and may need to administer a correction bolus.

Switching from DASH to Omnipod 5

Switching from DASH to Omnipod 5 involves a shift between different technologies. To make the switch, you’ll need to get the appropriate controller (unless opting for smartphone integration) and purchase Omnipod 5 pods. It’s also important to note that the Omnipod Dash pods and controller are not compatible with the Omnipod 5 system, as they operate on different technologies.

Cost and reimbursem*nt

Currently, there is no available information regarding the cost of the Omnipod 5 system or its reimbursem*nt by various public and private insurance plans in Canada.

Determining reimbursem*nt terms for new technologies, post-Health Canada approval, can be a timely process. These terms may also vary among provinces and across public or private healthcare systems.

It’s crucial to acknowledge the existing disparities in access to T1D technologies, which remain limited and costly for many individuals living with T1D. Addressing these inequalities in access is important to ensuring that all Canadians have the opportunity to use tools that are best suited for managing T1D.

A great way to do this is by sharing personal realities with T1D through participation in the BETTER registry. This wealth of information on daily life with T1D not only enriches diabetes research but also serves as a resource for advocating better access to technologies and treatments for T1D with policymakers.

Find out more about Omnipod and AID:

• Stay informed about the arrival of Omnipod 5 in Canada, by subscribing to the Omnipod 5 consumer mailing list.
• Learn more about Omnipod 5 setup and operation in the User Guide.
• Not sure if an artificial pancreas is right for you? Read our article Artificial pancreas: is it for you?

References:

Health Canada. Active licence search results. Page consulted on April 12, 2024. https://health-products.canada.ca/mdall-limh/information?licenceId=111065&type=active&lang=eng

Haute autorité de santé (HAS). (2024) Avis sur les dispositifs médicaux – Omnipod 5. [in French] https://www.has-sante.fr/upload/docs/evamed/CNEDIMTS-7278_OMNIPOD_5_30%20janvier%202024_7278_avis.pdf