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How a tubeless device provides three days of non-stop insulin delivery

How a tubeless device provides three days of non-stop insulin delivery

Ian Bolland caught up with the team at Insulet to find out more about Omnipod – an insulin delivery system which is a tubeless device that can provide three days of non-stop insulin delivery, and the app associated with it.  

Give us a bit of background on Omnipod – where did the idea come from?

Insulet, maker of the Omnipod insulin delivery system is headquartered in Massachusetts, and is an medical device company dedicated to simplifying the lives of people with diabetes through the use of its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its intuitively simple, wearable design, the disposable, waterproof Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. The Omnipod system actually came to be because a dad with a son newly diagnosed with diabetes said there has to be a better way to manage this disease. He sketched it out on the back of a napkin on a flight from California back to Boston almost 20 years ago. That same innovative approach has remained with the company ever since and is woven into the company’s fabric and culture.

Who did you work with to bring the product to life?

Many passionate engineers, scientists, entrepreneurs, business men and women, and those with diabetes or impacted by diabetes in some way helped bring the Omnipod system to life.

What kind of material is the pod made out of?

The Pod is made out of durable medical grade materials and is made up of 72 individual components that all co-exist “under the hood” of the Pod. We work with many materials vendors locally and across the globe.

How do you wear the pod?

The Pod adheres to the body with a medical grade adhesive and can be placed anywhere a person may give themselves an insulin injection. Popular and FDA-approved sites include back of the arms, lower back/buttocks, thigh, and abdomen. The Pod is also fully waterproof which further simplifies life because there is no need to disconnect for water activities like swimming or bathing like you would with a traditional tubed insulin pump.

How does it actually help manage a person’s insulin?

The Pod is worn on the body with no attachment to the hand-held controller (Personal Diabetes Manger, PDM). The Pod will deliver background basal insulin regardless of PDM location once programmed. The PDM is commonly carried in a separate carry case with all other supplies, kept in a gym bag, a locker, with the school nurse, in a purse, etc. Approximately 15 minutes before eating a meal or snack, a person would then use the PDM to deliver a mealtime bolus dose of insulin based on the amount of carbohydrates they are about to consume.

What happens after the three days of non-stop insulin delivery? Does it need topping up in some way?

The Pod has an automatic shut-off after 72 hours. There is a warning alarm to alert a user that they are approaching their 72-hour auto-shut off, at which point a person would deactivate their used Pod and activate a new Pod.

Give us an idea into the app behind it – what kind of features does it have?

The Omnipod Display app allows for a convenient display of PDM data on the user’s iOS smartphone including; Pod status, insulin therapy history, and alarms, as well as a “Find My PDM” feature. The Omnipod Display app allows users to manage their diabetes with discretion and provides the ability to check their PDM dashboards from their personal mobile devices. Users may also invite up to 12 people to view their PDM data using the Omnipod View app.

The Omnipod View app provides caregivers and family members the ability to remotely monitor Omnipod Dash System data for their loved ones. The same Omnipod Dash System data that is displayed on a smartphone can be viewed on one or more additional smartphones remotely to stay informed and help manage loved ones’ diabetes. It also provides caregivers with important information such as last bolus, insulin on board, and any recent alerts.

The Omnipod Display app and Omnipod View app iOS widgets, which can be accessed by swiping right from the home screen, can be configured next to the Dexcom Continuous Glucose Monitoring (CGM) G6 app iOS widget, providing an easy view of PDM and CGM data on a single smartphone screen.

Bret Christensen, chief commercial officer, said: “The Omnipod Dash mobile apps and widget capability are the first of their kind when it comes to monitoring insulin pump data and we are excited to bring this combined view of insulin delivery and Dexcom CGM data to our users. People look at their mobile phone countless times throughout the day and now Omnipod Dash users are able to conveniently and discreetly check their diabetes status or that of their loved ones’, in order to stay well-informed, help make diabetes management decisions, and make diabetes a smaller part of life.”

How secure is any data that is captured by it?

The Omnipod System is an FDA-regulated medical device and has to be secure and it received ISO 27001 certification of its Omnipod DASH System in November 2018.

Around that same time, the Omnipod DASH system also received DTSec (Diabetes Technology Society’s) Cybersecurity Standard for Connected Diabetes Device Security certification. Insulet is the only insulin pump company to have both certifications.

DTSec leverages ISO/IEC 15408 to provide a framework for risk-based, multi-stakeholder definition of security requirements. The Omnipod DASH System, Insulet’s next-generation platform, was designed to be the foundation for the company’s future innovation. With the ISO 27001 and DTSec certifications, the Omnipod DASH System is now globally recognised for incorporating the highest standards for information and cyber security and safety, including secure data transfer between the Pod and the personal diabetes manager (PDM), as well as secure cloud storage. 

Insulet CEO, Shacey Petrovic, added: “With last year’s launch of Omnipod Dash we created our online training program for DASH customers transitioning from Omnipod. This enables users to get started with online training without the need to leave home or meet with a clinician for support. Thanks to Dash’s simplicity, this web-based training has been a success and today it is being used extensively to support thousands of users and, in fact, many users transitioning from Omnipod to Omnipod Dash just rely on the intuitive user interface which provides step by step instructions to get started. These tools were created to support effective scaling of our business and have proven to be exceptionally helpful in our current environment.”

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