Shots: 

• Recently, Insulet announced the commercial launch of Omnipod 5 Automated Insulin Delivery System in the UK and Netherlands 

• Omnipod 5 is a tubeless AID system that communicates with a continuous glucose monitor (CGM), proactively correcting for highs and protecting against lows every five minutes, day and night 

• Today at PharmaShots, we have Hjalte Hojsgaard, shedding light on diabetes management through Omnipod 5, which is compatible with Dexcom G6 and Abbott Freestyle Libre 2 Plus 

Saurabh: The Omnipod 5 is a remarkable leap forward in diabetes management. Could you share some of the moments or unforeseen challenges your team encountered during its development and how they shaped the final product? 

Hjalte: You’re exactly right. Our Omnipod 5 Automated Insulin Delivery (AID) System is a game changer in diabetes management. It is the first tubeless AID system that communicates with a continuous glucose monitor (CGM), proactively correcting for highs and protecting against lows, every five minutes, day and night. The benefits for users and their medical teams are enormous, helping people living with diabetes live their best lives. 

One challenge was the difficulty designing an AID system for very young children who will eat and exercise simultaneously and experience unusually rapid swings in blood sugar. We were determined to make Omnipod 5 work for them with the teams 

completing an extra cycle of clinical development and algorithm tuning. As a result, Omnipod 5 was the first system cleared in the US for children ages 2 years and up. 

Saurabh: The press release mentions strong clinical results for Omnipod 5. Could you provide a more detailed breakdown of these results, focusing on key metrics like A1c reduction, time in range improvement, and any other relevant clinical outcomes? 

Hjalte: First, the Omnipod 5 Automated Insulin Delivery (AID) System is cleared for type 1 diabetes therapy for ages 2 and older. In 2022, Omnipod 5 was cleared by the U.S. Food and Drug Administration (FDA) and subsequently received CE Mark approval under the European Union Medical Device Regulation (MDR) in September after demonstrating both safety and efficacy. 

This included two clinical studies which demonstrated the following. Improved time in range by 3.7 hours per day in children—2.6 hours per day in children ages 2-5.9 years and 2.2 hours per day in adolescents and adults. Additionally, clinical study participants experienced a reduction in A1C of 0.71 in children (0.5% in children ages 2-5.9 years) and 0.38% in adolescents and adults. While clinical data is really important, so is designing and delivering a system that is simple to use and doesn’t require a lot of work for people living with diabetes. 

Saurabh: Omnipod 5 boasts unique dual compatibility with both Dexcom G6 and Abbott FreeStyle Libre 2 Plus. What was the strategic thinking behind this decision, and what technical obstacles did your team overcome to achieve this dual compatibility? 

Hjalte: Our thinking and decision-making were rooted in providing our users with more choices. Some users are very keen about their Dexcom CGM sensor whilst others are equally keen about their Abbott CGM. As both Dexcom and Abbott introduce their next generation sensors, there is a massive amount of work involved to get that right from a technical, software, engineering, manufacturing, and commercialization perspective. 

Our mission is to improve the lives of people with diabetes. This requires a holistic approach and our entire team working in unison to deliver the best possible outcome for our customers. 

Saurabh: How did customer feedback influence the design of Omnipod 5, especially its waterproof feature? What specific user needs or desires led to this feature, and how are you measuring its positive impact on users' lives? 

Hjalte: Living with diabetes can be overwhelming. Making diabetes management less burdensome is our goal, taking a multi-disciplinary approach that includes, for example, our medical, engineering, design, and customer experience teams. 

Insulet invests heavily in understanding user behavior, human factoring engineering, design iterations where we test, refine and re-test on every element of our design, which is different than how most medtech innovation happens. This includes having many conversations in various forms and forums with our users. We look for opportunities for our teams to connect with the community. We've had designers go to diabetes camps and other events for children with diabetes to get the appreciation for what it's like to live with diabetes. Our teams really appreciate the opportunity to do that as it really helps them to execute our mission. With Omnipod 5, we get data pushed to our cloud every five minutes from the device. We get a huge amount of insight into both user behavior and how well the system is working from a therapy perspective, that we're able to learn in real time, just like consumer tech companies. This is a new approach in medtech with the ability to learn not just in the micro by studying user behavior, but learning the macro by absorbing large volumes of data and preparing for future iterations of the product to make it even better. The Omnipod 5 form factor—wearable, durable, small, and discreet, is revolutionizing diabetes therapy, allowing our users to live their best lives. The waterproof feature (the Pod has an IP28 rating for up to 7.6 meters/25 feet for 60 minutes) is a great example of that, enabling people living with diabetes to participate fully in activities like swimming, kayaking, and even just be able to take a shower without having to disconnect from their pump. 

Saurabh: What resources and support programs does Insulet have in place to assist healthcare providers and users in the U.K. and the Netherlands who are new to Omnipod 5 or transitioning from other insulin delivery systems? 

Hjalte: As we’ve said, Omnipod 5 is a game changer. Managing diabetes with multiple daily injections (MDI) has been the widely available insulin delivery therapy for decades. As is the case with change that comes with most if not all disruptive technologies, education and awareness (grounded by strong science and clinical studies) are key. Fortunately, Insulet has an amazing medical affairs team that works with key opinion leaders, healthcare providers, academic institutions, and health insurance organizations to spread the word about how impactful our technology is. Insulet has a team of Clinical Service Managers in the field who help train both healthcare professionals and people living with diabetes all they need to understand Pod Therapy and its benefits. 

Saurabh: Could you provide an overview of the pricing and reimbursement landscape for Omnipod 5 in the U.K. and the Netherlands? How is Insulet working with healthcare systems and payers to ensure patient access to this innovative technology? 

Hjalte: In the UK, national policy supports access and reimbursement for HCL technology, including Omnipod 5. NICE guidance, which covers England and Wales, has recommended adoption of HCL in type 1 diabetes and this has been accompanied for England by a structured five-year implementation plan. In Scotland, new ear-marked funding was recently announced to support the roll-out of HCL. Insulet is working closely with the NHS at both national and local level to help make the implementation plans a success and to ensure access to Omnipod 5 as quickly as possible for people who will benefit from and choose to use it. 

In the Netherlands, access to the technology is determined by the willingness of 10 healthcare insurance companies to fund it for their subscribers. A number of these companies have already decided to fund Omnipod 5, and we are confident that the others will follow their lead. Insulet is working with its partner distribution companies in the Netherlands to secure universal coverage, ensuring that the health insurance companies are fully aware of the value of the technology to people with type 1 diabetes. 

Saurabh: What strategic considerations informed the decision to launch Omnipod 5 initially in the U.K. and the Netherlands? What unique characteristics of these markets make them suitable for early adoption and provide valuable feedback for further global expansion? 

Hjalte: Today, Omnipod products are available in 25 countries, including throughout much of Europe. Every market is different in how healthcare is regulated, delivered, and paid for. So, there isn’t a one size fits all approach. As the world’s first and only tubeless automated insulin delivery system, Omnipod 5 is a novel, large, and complex regulatory submission. We are excited to bring Omnipod 5 to our customers worldwide. In fact, with the recent launch of Omnipod 5 in France, the majority of our European customers now have access to Omnipod 5. We are continuously working to expand the availability of Omnipod 5 internationally and look forward to simplifying the lives of people with diabetes globally. 

Image Source: Canva 

About the Author: 

Hjalte Hojsgaard 

Hjalte Hojsgaard is Vice President and General Manager for UK, Belenux (Belgium, Netherlands and Luxemburg) and DACH (Germany, Austria and Switzerland) regions. Since joining Insulet in 2011, he has served in numerous leadership roles with increasing responsibilities around the world.  He is a graduate of Copenhagen Business School where he earned Bachelor of Science and Master of Business Administration degree. Additionally, Hjalte earned a Master of Science degree from Middlebury Institute of International Studies at Monterey. 

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