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, today presented new Omnipod® 5 Automated Insulin Delivery (AID) System study results in type 2 diabetes and other clinical data in type 1 diabetes at the Advanced Technologies & Treatments for Diabetes (ATTD) conference in Barcelona, Spain, and online.
Insulet presented the results of its feasibility study to evaluate use of the Omnipod 5 in adults with type 2 diabetes. The Company also shared Omnipod 5 user experience data in the same population and built upon the existing body of evidence for the treatment of type 1 diabetes with new insights from the Omnipod 5 pivotal study data.
Type 2 Diabetes Study Results
The Omnipod 5 System was used by 24 adults aged 18 to 75 years with type 2 diabetes and an HbA1c from 8% to 12%. These adults were using insulin injection therapy prior to the study, either through multiple daily injections or basal-only injections. Participants used the Omnipod 5 System in Automated Mode for eight weeks, and then had the option to continue in a six-month extension phase. The group of 12 participants previously using multiple daily injections had an average age of 62 years, diabetes duration of 20 years, and baseline HbA1c of 9.4% (79 mmol/mol), while the group of 12 participants previously using basal-only injections had an average age of 59 years, diabetes duration of 18 years, and baseline HbA1c of 9.5% (80 mmol/mol).
Overall, the study showed significant improvements in HbA1c by 1.3% (14.2 mmol/mol) and improved Time in Range (TIR) by 4.6 hours per day during the eight-week study compared with baseline. Additionally, hypoglycemia (as measured by percent time glucose levels were under 70mg/dL) was reduced by 4 minutes per day in the group previously using multiple daily injections and did not change for the group previously using basal-only injections. This latter group already showed very low rates of hypoglycemia and resulted in a median of just 0.04% of time under 70mg/dL using Omnipod 5.
The improvements in glycemic results were achieved alongside a reduction in insulin use (-29 units per day, or 31.4%) for the prior multiple daily injections group (no change for prior basal-only injection group), and with no change in Body Mass Index (BMI) in either group. Fourteen participants who volunteered for a post-study human factors interview reported a System Usability Scale of 90.5 after the conclusion of the study. Twenty-two of the 24 participants chose to continue system use in an optional six-month extension, the results of which will be shared at ADA 2022.
“This is the first AID system study of people with type 2 diabetes conducted in the United States and the results are very impressive,” said Dr. Trang Ly MBBS, FRACP, PhD, Insulet Senior Vice President and Medical Director. “It’s an exciting milestone for Insulet, as we look ahead to a pivotal study for this population. We are driven in our pursuit to provide Omnipod 5 to as many people with diabetes as possible, and this data demonstrates the potential benefits Omnipod 5 can provide for the type 2 diabetes community.”
Omnipod 5 is currently cleared for use in the U.S. for individuals with type 1 diabetes aged 6 years and older. Omnipod 5 is the first tubeless automated insulin delivery system in the U.S. that integrates with the Dexcom G6 Continuous Glucose Monitoring (CGM) System and a compatible smartphone to automatically adjust insulin and help protect against highs and lows.
New Omnipod Research in Treatment of Type 1 Diabetes
In addition, Insulet will present data and clinical outcomes for children and adults with type 1 diabetes, including data on the performance of Omnipod 5 with missed boluses, for a total of five oral and poster presentations at ATTD.
Schedule of Oral Presentations
Saturday, April 30, 11:08 – 11:16 a.m. CET Session 4, Hall 118
Performance of Omnipod® 5 Automated Insulin Delivery System at specific glucose targets from 110-150mg/dL over three months in very young children with type 1 diabetes with Dr. Sarah MacLeish
Saturday, April 30, 11:08 – 11:16 a.m. CET Session 6, Hall 120
Impact of X-Ray exposure from Computed Tomography (CT) on a wearable insulin delivery device with Dr. Paul Johnson
Schedule of Poster Presentations
Poster 002 - Improvement in HbA1c after 8 weeks of Omnipod® 5 Automated Insulin Delivery System use in adults with type 2 diabetes: from injections to closed-loop therapy with Dr. Anne Peters
Poster 288 - User experience of the Omnipod® 5 Automated Insulin Delivery System in adults with type 2 diabetes with Dr. Sanghyun Park
Poster 003 - Performance of the Omnipod® 5 Automated Insulin Delivery System with and without pre-meal bolus with Dr. Laya Ekhlaspour
Additional Programs at ATTD
Insulet will also host a symposium, “The Evolution of Omnipod®: Advancing the Journey to Simplify Life with Diabetes,” on Friday, April 29, at 6:15 p.m. CET in Hall 112. Dr. Trang Ly will host the event, discuss the development history of Insulet’s innovative Omnipod products and present the clinical cases using Omnipod® DASH, as well as supportive real-world data. Drs. Anders Carlson and Sarah MacLeish will share Omnipod 5 clinical data and demonstrate the value of customization in automated insulin delivery in different patient cohorts, including individuals with type 1 and type 2 diabetes.
Members of the Insulet team will be present to discuss Omnipod DASH with healthcare providers and other ATTD registrants, as well as offer visitors the opportunity to participate in a Pod Challenge. For every person who tries on a demonstration (non-functioning) Pod, Insulet will make a donation to the Spare a Rose fundraising campaign. Spare a Rose supports Insulin for Life, a global charitable organization that provides insulin, diabetes supplies, education, and advocacy to support people with diabetes in under-resourced countries.
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 disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s latest innovation, the Omnipod® 5 Automated Insulin Delivery System, is a tubeless automated insulin delivery system, integrated with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and is fully controlled by a compatible personal smartphone. 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 24, 2022 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 in material respects from those projected in these forward-looking statements. Insulet undertakes no obligation to publicly update or revise any forward-looking statements.
©2022 Insulet Corporation. Omnipod, Omnipod DASH, and Omnipod 5, are trademarks or registered trademarks of Insulet Corporation in the United States of America and other various jurisdictions. All rights reserved. Dexcom G6 is a registered trademark of Dexcom and used with permission.
