Insulet Presents Positive Omnipod Horizon Hybrid Closed-Loop Study Results In Children

BILLERICA, Mass.--(BUSINESS WIRE)--Insulet Corporation (NASDAQ:PODD) (Insulet or the Company), the leader in tubeless insulin pump technology with its Omnipod^® Insulin Management System (Omnipod System), today announced additional promising data from the first feasibility study of the Omnipod^® Horizon™ Automated Glucose Control System (Omnipod Horizon) hybrid closed-loop system. Initial results presented earlier this year demonstrated Insulet’s personalized model predictive control (MPC) algorithm performed well, was safe during the day and night for adults with type 1 diabetes, and was very effective at night with minimal hypoglycemia and excellent fasting glucose.¹ New data revealed today at the American Diabetes Association (ADA) 77th Scientific Sessions in San Diego demonstrated pediatric and adolescent populations experienced positive results consistent with the performance in the adult population, reinforcing Insulet’s expectation of the many future benefits of the Omnipod Horizon.

The 36-hour study included a modified version of Insulet’s Omnipod System, a Dexcom^® continuous glucose sensor, and Insulet’s personalized MPC algorithm with announced meals ranging from 30-90 grams of carbohydrates and limited physical activity. Overall, the study included 34 adults, 12 adolescents and 12 pediatric patients with type 1 diabetes.^1-3 Key findings in the pediatric and adolescent patients included greater than 70% of time spent in the target blood glucose range overall and approximately 85% or greater time in the target range overnight. These initial results indicate that the algorithm performance can address the unique challenges faced by pediatric populations with high insulin sensitivity and adolescents who tend to be insulin resistant.

“We are thrilled to see positive results that show the potential of the Omnipod Horizon to improve clinical outcomes among pediatric and adolescent age groups in addition to the adult population, especially because of the unique challenges children with type 1 diabetes face,” said Dr. Trang Ly, Vice President and Medical Director. “The early findings indicate this hybrid closed-loop algorithm has demonstrated good improvements in glycemic control during the day and night and we are looking forward to further advances with this extremely promising system.”

“This new data for our Omnipod Horizon Automated Glucose Control System illustrates that the technology is a potentially exciting solution for providing exceptional glucose control for people of all ages who are living with type 1,” said Shacey Petrovic, President and Chief Operating Officer. “Insulet is committed to improving the lives of people with diabetes, and we’re delighted to see the tremendous potential impact Horizon could have on improving the quality of life and clinical outcomes for Podders.”

¹ Buckingham BA, Pinsker JE, Christiansen, MP, Schneider J, Peyser TA, Dassau E, Bok Lee J, O’Connor J, Layne JE, Ly TT. Feasibility of Omnipod Hybrid Closed-loop Control in Adults with Type 1 Diabetes Using an Enhanced Personalized Model Predictive Control Algorithm. Presented at the 10th International Conference on Advanced Technologies & Treatments for Diabetes, February 17, 2017.

² Buckingham BA, Forlenza GP, Schneider J, Peyser TA, Dassau E, Bok Lee J, O’Connor J, Layne JE, Ly TT. Safety and Feasibility of Omnipod Hybrid Closed-Loop in Children Aged 6-12 Years with Type 1 Diabetes Using an Enhanced Personalized Model Predictive Control Algorithm. Presented at the American Diabetes Association® (ADA) 77th Scientific Sessions, June 12, 2017.

³ Buckingham BA, Forlenza GP, Schneider J, Peyser TA, Dassau E, Bok Lee J, O’Connor J, Layne JE, Ly TT. Safety and Feasibility of Omnipod Hybrid Closed-Loop in Adolescents with Type 1 Diabetes Using an Enhanced Personalized Model Predictive Control Algorithm. Presented at the American Diabetes Association® (ADA) 77th Scientific Sessions, June 12, 2017.

About the Omnipod Insulin Management System:

The Omnipod Insulin Management System is an innovative continuous insulin delivery system that provides all the proven benefits of continuous subcutaneous insulin infusion (CSII) therapy in a way no conventional insulin pump can. The Omnipod System’s innovative design and features allows people living with diabetes to live their life—and manage their diabetes—with unprecedented freedom, comfort, convenience, and ease. The Omnipod System consists of two components: (i) a Pod that stores and delivers insulin; and (ii) a Personal Diabetes Manager (PDM) that wirelessly programs the user’s personalized insulin delivery, calculates suggested doses and insulin on board, and has a convenient, built-in blood glucose meter. The small, light-weight Pod can be worn in multiple locations, including the abdomen, hip, back of upper arm, upper thigh or lower back and, because it is waterproof (IPX8), there is no need to remove when showering, swimming or performing other activities. This means that Omnipod can provide up to three days of non-stop insulin delivery, without the need to disconnect a tube set or manually inject insulin. The Pod and PDM communicate wirelessly to offer precise, personalized and continuous insulin delivery with customizable basal and bolus delivery options, as well as important safety checks. The Pod’s auto-cannula insertion is quick, simple, and virtually pain-free. Users never have to handle a needle. The user simply pushes a button on the PDM and the Pod’s automated insertion system inserts the cannula beneath the skin and begins delivering insulin according to the user’s programmed basal rate.

The Omnipod System is the world’s first commercially available tubeless insulin delivery system that allows users to live untethered by tubing and without the stress and anxiety of multiple daily injections. By breaking down the barriers to insulin pump therapy, the Omnipod System offers freedom for users to live life on their own terms and with the ease of use they deserve.

About Insulet Corporation:

Insulet Corporation (NASDAQ:PODD) is an innovative medical device company dedicated to making the lives of people with diabetes easier. Through its Omnipod Insulin Management System, Insulet seeks to expand the use of insulin pump therapy among people with insulin-dependent diabetes. The Omnipod is a revolutionary and easy-to-use tubeless insulin pump that provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s Delivery Systems business also partners with global pharmaceutical and biotechnology companies to adapt the Omnipod technology platform for the delivery of subcutaneous drugs across multiple therapeutic areas. Founded in 2000, Insulet Corporation is based in Billerica, Massachusetts. For more information, please visit: http://www.myomnipod.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 28, 2017 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.

© 2017 Insulet Corporation, Horizon, Omnipod and Podder are trademarks or registered trademarks of Insulet Corporation. All rights reserved. All other trademarks are the property of their respective owners. The use of third party trademarks does not constitute an endorsement or imply a relationship or other affiliation.