Omnipod 5 Insights & Next-Gen Advancements

Aug 11, 2023

Welcome to our latest blog post, where we're excited to bring you the most recent updates from Insulet following the ADA2023 event.

Our aim is to keep you informed about the latest developments in the world of diabetes care.

In this article, we'll delve into several noteworthy announcements:

Real-World Insights: Discover key takeaways from 55,000+ Omnipod 5 users, offering real-world data on diabetes management.
Global Expansion: Omnipod 5 now live in the UK; Germany launch set for fall 2023, extending its reach.
iOS App Progress: Get the scoop on the Omnipod 5 iOS app's FDA submission, enhancing user experience.
FreeStyle Libre Integration: Stay tuned for an Omnipod 5 and FreeStyle Libre 2 collaborative study, with potential reimboursement implications.
Type 2 Focus: Insulet's commitment to innovation for type 2 diabetes patients remains steadfast.
Next-Gen Algorithm: Sneak peek into the groundbreaking next-gen Omnipod 5 algorithm.

We're thrilled to share these insights with you and to be a part of the journey toward a brighter, more manageable future for those living with diabetes.

Let's dive into the details together.

1. Insights from Omnipod 5 Users: Unveiling Real-World Data

With an ever-growing user base, Insulet now has over 100,000 active Omnipod 5 users in the US.

The beauty lies in the data, made possible by the built-in SIM card within the Omnipod 5 controller that diligently captures all user information.

At ADA2023, a spotlight was shone on a dataset of 55,150 individuals with type 1 diabetes who used the Omnipod 5 system.

Diving deeper, this group was segmented based on their chosen target values:

Interestingly, a substantial number of users, especially children, employed two or more target values (refer to overview here).
The prevailing target value selected is the lowest at 110 mg/dl (6.1 mmol/l), though higher targets are typically favored for younger children (see overview here).

Depending on the chosen target value, here are the average Time In Range (TIR) and Time Below Range (TBR):

29,706 users aimed for the most aggressive target (110 mg/dl or 6.1 mmol/l): TIR 69%, TBR 1.1%
17,233 users aimed for 120 mg/dl (6.7 mmol/) target: TIR 62%, TBR 0.9%
8,211 users aimed for 130 mg/dl (7.2 mmol/l) target: TIR 54%, TBR 0.7%

Notably, while these TIR figures might be slightly lower than the pivotal trial, Omnipod 5 continues to deliver enhanced glycemic control across various user groups and subgroups.

An equally remarkable achievement is the remarkably low incidence of hypoglycemia observed.

The median Omnipod 5 user had a 94% "time in automode", underscoring the system's usability and practicality.

This real-world data underscores Omnipod 5's effectiveness in achieving a good Time In Range, especially when used with the most aggressive target.

2. Omnipod 5 launched in UK in June, Germany planned for fall 2023

Omnipod 5 made its successful debut in the UK this June, and its upcoming launch in Germany this autumn is right on schedule.

During a recent investor call, Dr. Jom Hollingshead, CEO of Insulet, revealed the company's ambitious goal to ensure that Omnipod 5 becomes accessible to "most" of Insulet's European customers by the conclusion of 2024.

3. Omnipod 5 iOS app has been submitted to the FDA

The Omnipod 5 iOS app has been officially sent for review to the FDA.

This app feature was highly requested by users, and Insulet has made efforts to improve the user interface to seamlessly blend with the Apple iOS ecosystem.

Furthermore, an interesting inclusion named the "Custom Food feature" has been integrated into the iOS app, enhancing the ease of inputting carbohydrate information.

4. Integration of FreeStyle Libre2 in Omnipod 5

Insulet has successfully incorporated the FreeStyle Libre 2 sensor into the Omnipod 5 app,

and the Omnipod 5 Pod is capable of seamless communication with the FreeStyle Libre 2 sensor.

A randomized controlled study featuring this new integration is set to begin shortly in the UK, France, and Belgium.

The study, known as "RADIANT," will involve enrolling 200 participants aged 4 to 70 with type 1 diabetes and a HbA1c 7.5-11%.
Participants will be divided into two groups using a 2:1 ratio – one group utilizing Omnipod 5 + FreeStyle Libre 2, and the other using MDI + FreeStyle Libre 2.

The main objective of this thirteen-week study is to observe changes in A1c levels from the starting point, aiming to gather evidence for potential reimbursement.

Moreover, Insulet has plans to integrate the Dexcom G7 sensor with the Omnipod 5 system.

However, specific timelines for this integration have not been mentioned thus far.
During ADA2023, Dr. Trang Ly, the Medical Director of Insulet, mentioned that she's currently testing the system and that it offers an excellent user experience.

5. Promising Data on Omnipod 5 Use in Type 2 Diabetes

During ADA2023, Dr. Anne Peters (Universiy of Southern California) presented positive real-world data of off-label Omnipod 5 use in adults with type 2 diabetes (see abstract here).

Participants (n=2,336) used a 110 mg/dL target, and each provided over 90 days of data.
Median TIR across all age groups was 70% with nearly no time spent in hypoglycemia (0.2%).
The median GMI across all age groups was 7.2%, which Dr. Peters called “excellent.”
Moreover, there were no significant differences between age groups in either TIR or GMI.

These findings hold great promise as Insulet endeavors to extend Omnipod 5's usage to include type 2 diabetes.

Anticipating future updates, possibly at ATTD 2024, we're eager to learn more about the outcomes of the company's ongoing SECURE-T2D pivotal study, set to conclude in December 2023.

Meanwhile, subsequent to receiving FDA clearance for Omnipod GO (a basal-only patch for type 2 diabetes) last April,

the company is on track to conduct a pilot in the US this year, with commercialization targeted for 2024.

While type 1 diabetes remains a focal point for the company, it's evident that many of Insulet's future ambitions are centered around type 2 diabetes.

6. Update on Omnipod 5 next gen algorithm

Insulet made intriguing revelations during ADA2023 that shed light on their next-gen algorithm named "EVOLUTION."

"I'm very pleased to share that we're on the cusp of starting feasibility studies with our next generation algorithm in New Zealand with enrollment to start next month. Our innovation focus at Insulet is to simplify life with diabetes and reduce burden for our users even further. And we're excited to start testing algorithm advancements that we've been developing based on the unique data set that we have on Omnipod 5." - Dr. Trang Ly, the Medical Director of Insulet at ADA2023

Additionally, during the ADA2023 event, Insulet showed on abstract on an "Autobolus" feature.

This advanced system provides an automatic bolus response ("autobolus") to rising glucose levels, for example after meals.
Insulet's initial in-silico data indicates the potential to enhance Time in Range for both adults and pediatrics who may occasionally miss boluses for up to three meals within a 24-hour period.

In summary:

The real-world data collected from over 55,000 Omnipod 5 users with type 1 diabetes stands as a testament to its real-world effectiveness.
Omnipod 5's global expansion, from its launch in the UK to its imminent introduction in Germany, represents a significant leap toward granting more individuals access to innovative solutions.
The advancements made in developing the Omnipod 5 iOS app and its ongoing integration with FreeStyle Libre 2 underscore Insulet's unwavering commitment to enriching user experiences.
Insulet's unwavering commitment to addressing the requirements of individuals with type 2 diabetes underscores its dedication to inclusivity, recognizing that progress knows no limits in the realm of enhancing lives.
The intriguing preview of the upcoming Omnipod 5 next-gen algorithm offers a glimpse into a future brimming with advancements that have the potential to redefine diabetes management.