Insulet to Present Results from First Omnipod® 5 Randomized Controlled Trial (OP5-003) at the 17th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD)

Rhea-AI Summary

Insulet Corporation (PODD) to present new clinical evidence on Omnipod 5 Automated Insulin Delivery System at ATTD conference, showcasing positive outcomes and real-world evidence.

Medical Research Analyst

The presentation of the OP5-003 Trial results at the 17th International Conference on Advanced Technologies & Treatments for Diabetes is a significant event for stakeholders in Insulet Corporation and the broader medical device sector. The trial's international scope, including participants from the United States and France, marks a pivotal expansion in the evaluation of the Omnipod 5 Automated Insulin Delivery System. This is particularly noteworthy as it's the first randomized controlled trial for the system conducted with international participants.

The data demonstrating the efficacy and safety of the Omnipod 5 System in comparison to traditional insulin pump therapy could potentially shift treatment paradigms in diabetes management. The evidence suggesting that Omnipod 5 could become the standard of care has far-reaching implications, possibly influencing prescribing habits, insurance coverage and patient outcomes. The presentation of Real-World Evidence encompassing over 100,000 users offers a robust dataset that could substantiate the system's real-world effectiveness and safety, which is crucial for regulatory bodies, healthcare providers and payers.

Healthcare Economist

The Omnipod 5's potential establishment as a standard of care for diabetes management could also have significant economic implications. The healthcare system could see a shift in cost structures, with initial investments in AID technology potentially leading to long-term savings through reduced complications and hospitalizations. The Real-World Evidence suggesting high Time in Range and low rates of hypoglycemia indicates that the Omnipod 5 system may contribute to better health outcomes, which can translate into economic benefits for both the healthcare system and patients.

Furthermore, the data presented could influence policy development regarding equitable access to diabetes technology. The presentation at the conference focusing on the pathway to equitable access underscores the importance of aligning medical advancements with health policy to ensure that innovations like the Omnipod 5 are available to a broader population, potentially reducing disparities in diabetes care.

Market Research Analyst

From a market perspective, the presentation of the OP5-003 Trial results and the extensive Real-World Evidence could significantly impact Insulet's market position. Positive trial outcomes and user data could enhance the company's reputation, potentially leading to increased adoption of the Omnipod 5 system. This could result in market share gains and provide a competitive edge over other insulin delivery systems.

The expansion of clinical evidence to an international audience at the ATTD conference also serves as a strategic move to tap into global markets, which could open up new revenue streams for Insulet. The company's focus on product innovation and the upcoming presentation on future product developments may further stimulate investor interest and confidence in the company's growth trajectory.

• Conducted in the United States and France, the OP5-003 Trial is the first Omnipod 5 study to include international participants.
• The OP5-003 Trial Presentation and Insulet Symposium will convey the importance of automated insulin delivery (AID) technology as Standard of Care.
• An expanded set of Omnipod 5 Real-World Evidence with more than 100,000 users will also be presented, showing positive outcomes and insights to guide system use and optimization.

ACTON, Mass.--(BUSINESS WIRE)-- Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod^® brand of products, will present new clinical evidence related to the Omnipod 5 Automated Insulin Delivery System (Omnipod 5) at the 17^th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) taking place March 6 – 9, 2024 in Florence, Italy, and online.

“We are thrilled to unveil the results of our inaugural randomized controlled trial with groundbreaking insights from international Omnipod 5 users,” said Dr. Trang Ly MBBS, FRACP, PhD, Insulet Senior Vice President and Medical Director. “This evidence further demonstrates the superiority of Omnipod 5 for people with diabetes and validates the importance of AID as the standard of care worldwide. Completion of this trial represents a key step forward in increasing global access to this technology.”

The OP5-003 international randomized controlled trial results will be presented by Professor Eric Renard, MD, PhD of Montpellier University Hospital on Friday, March 8. Professor Renard will present evidence of the efficacy and safety of the automated Omnipod 5 System compared to insulin pump therapy with a continuous glucose monitoring (CGM) in adults with type 1 diabetes in the United States and France. It is the first Omnipod 5 randomized controlled trial to date, and the first time the system has been evaluated in participants living outside of the United States.

Omnipod 5 Real-World Evidence will also be shared during an oral presentation on Saturday, March 9 by Dr. Fraser Gibb, PhD FRCP Consultant Physician, Edinburgh Centre for Endocrinology & Diabetes and Honorary Clinical Reader, University of Edinburgh UK, as well as through three poster presentations.

“The Omnipod 5 Real-World Evidence database continues to provide a wealth of information for healthcare providers looking to understand the system’s performance and optimization under real-world conditions,” said Dr. Gibb. “Insulet’s tubeless AID innovation is having a remarkable impact on people with diabetes across all age groups with diverse insulin needs. The importance of this database and the insights it provides healthcare providers cannot be overstated.”

With data on more than 100,000 users in the U.S. now available, Dr. Gibb and others will share new insights, including outcomes for those using the system for more than one year, data on users with low insulin requirements, and how the system responds to a missed meal bolus in the real world.

An earlier analysis of the Real-World Evidence database as of July 2023 was recently published in Diabetes Technology and Therapeutics. The paper presents the largest published U.S. dataset in the current AID landscape and demonstrates positive clinical outcomes under real-world conditions across a diverse population, including prior pump and MDI users, those on Medicare and Medicaid, and across all age groups greater than two years. Users at an average target of 110 mg/dL achieved nearly 70% Time in Range while maintaining very low rates of hypoglycemia.

ATTD Presentations and Events

Insulet will sponsor a symposium on Wednesday, March 6 from 2:40 – 4:10 p.m. CET in Hall G Basilica, entitled “The Omnipod 5 Era: How Tubeless Innovation Helps Automated Insulin Delivery Become Standard of Care.” Chaired by Dr. Ly, the symposium will focus on Omnipod 5 and the importance of AID technology as standard of care for people with diabetes. Clinical evidence from Insulet’s Omnipod 5 Real-World Evidence database and results from the Company’s EVOLUTION Study (the first feasibility study of Insulet’s work to advance their AID algorithm) will be presented. Dr. Ly will also provide a Company update on future product innovations.

Speakers will include:

• Dr. Paolo di Bartolo, Chief of Ravenna Diabetes Center at the Romagna Local Health Authority in Italy
• Prof. May Ng, OBE Honorary Professor, Consultant Pediatric Endocrinologist at Mersey West Lancashire Teaching Hospitals, Edge Hill University and University of Liverpool in the United Kingdom
• Dr. Martin de Bock, Associate Professor and Pediatric Endocrinologist at the University of Otago, Christchurch in New Zealand
• Dr. Trang Ly, Senior Vice President, Medical Director at Insulet Corporation in the United States

A total of eight posters and presentations on the Omnipod 5 System and the Omnipod DASH^® Insulin Management System will be presented at ATTD:

Oral Presentations

Friday, March 8, 9:30 – 10:30 a.m. CET Session 4, Hall I

Oral Presentation O074 - Efficacy and Safety of the Automated Omnipod 5 System Compared to Insulin Pump Therapy in Adults with Type 1 Diabetes: A Randomized Controlled Trial with Professor Eric Renard

Saturday, March 9, 11:30 – 1:00 p.m. CET Session 9, Hall I

Oral Presentation O075 - Real-World Glycemic Outcomes of 71,679 Adults with Type 1 Diabetes Using the Omnipod 5 Automated Insulin Delivery (AID) System with Cloud-Based Data Management with Dr. Fraser Gibb

Poster Presentations

e-Poster EV083 - Real-World Glycemic Outcomes of 29,783 Children and Adolescents with Type 1 Diabetes Using the Omnipod 5 Automated Insulin Delivery (AID) System with Cloud-Based Data Management with Dr. Fiona Campbell

e-Poster EV099 - Use of the Omnipod 5 Automated Insulin Delivery (AID) System with Low (Fewer than 5 Units) Insulin Requirements: Real-World Evidence with Dr. Greg Forlenza

e-Poster EV095 - Automatic Glucose Correction Following a Missed Meal Bolus with the Omnipod 5 Automated Insulin Delivery (AID) System: Real-World Evidence with Dr. Laya Ekhlaspour

e-Poster EV157 - Next Generation Automated Insulin Delivery Algorithm for Omnipod: Assessment of Safety in a Supervised Hotel Setting with Dr. Tom Wilkinson

e-Poster EV338 - Real-World Outcomes of a Tubeless Insulin Management System in 241 Australians Living with Type 1 Diabetes with Dr. Ben Nash

e-Poster EV456 - The Insulin Experience Study: Comparing French Users’ Experience with Tubeless Insulin Pumps, Tubed Pumps, and Hybrid Closed Loops with Professor Jean-Pierre Riveline

e-Poster presentations will be available throughout the entire conference.

Exhibit Hall Activities and Programs

As part of Insulet’s efforts to improve access to diabetes technology, Insulet will host a presentation, “Policy Development in HCL Technology – the Pathway to Equitable Access” at the Omnipod booth on the Exhibit Hall floor. Professor Partha Kar of the United Kingdom will be Insulet’s guest speaker. This presentation will take place on Thursday, March 7 at 12:00 p.m. CET and Friday, March 8 at 10:30 a.m. CET.

Insulet representatives will be available to provide Omnipod product demonstrations to conference attendees, offering healthcare professionals the chance to experience Omnipod DASH and Omnipod 5 first-hand.

About Insulet Corporation:

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone or the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit: insulet.com and omnipod.com.

Forward-Looking Statement:

This press release may contain forward-looking statements concerning Insulet's expectations, anticipations, intentions, beliefs, or strategies regarding the future. These forward-looking statements are based on its current expectations and beliefs concerning future developments and their potential effects on Insulet. There can be no assurance that future developments affecting Insulet will be those that it has anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond its control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements, and other risks and uncertainties described in its Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission on February 23, 2024 in the section entitled "Risk Factors," and in its other filings from time to time with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should any of its assumptions prove incorrect, actual results may vary materially from those projected in these forward-looking statements. Insulet undertakes no obligation to publicly update or revise any forward-looking statements.

©2024 Insulet Corporation. Omnipod and Omnipod DASH are trademarks or registered trademarks of Insulet Corporation in the United States of America and other various jurisdictions. All rights reserved.

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Investor Relations:

Deborah R. Gordon

Vice President, Investor Relations

(978) 600-7717

dgordon@insulet.com

Media:

Angela Geryak Wiczek

Senior Director, Corporate Communications

(978) 932-0611

awiczek@insulet.com

Source: Insulet Corporation

FAQ

What is the significance of the OP5-003 Trial Presentation and Insulet Symposium?

The OP5-003 Trial Presentation and Insulet Symposium highlight the importance of automated insulin delivery technology as the Standard of Care and present new clinical evidence related to the Omnipod 5 System.

Who will present the international randomized controlled trial results of the Omnipod 5 System?

Professor Eric Renard of Montpellier University Hospital will present the international randomized controlled trial results of the Omnipod 5 System.

What insights will be shared during the presentation of Omnipod 5 Real-World Evidence?

The presentation will share insights on the efficacy, safety, and performance of the Omnipod 5 System under real-world conditions, including outcomes for different user groups and system responses to various scenarios.

What key topics will be covered in Insulet's symposium at the ATTD conference?

The symposium will focus on the Omnipod 5 System, the importance of AID technology, clinical evidence from the Real-World Evidence database, and results from the EVOLUTION Study.

Who are some of the speakers at Insulet's symposium?

Speakers at the symposium include Dr. Paolo di Bartolo, Prof. May Ng, Dr. Martin de Bock, and Dr. Trang Ly among others.