Business Wire 17-Feb-2017 6:00 AM
First Feasibility Study on the Automated Glucose Control Algorithm Demonstrates Beneficial Results in Adults with Type 1 Diabetes
BILLERICA, Mass.--(BUSINESS WIRE)-- Insulet Corporation(NASDAQ: PODD) (Insuletor the Company), the leader in tubeless insulin pump technology with its OmnipodInsulin Management System (Omnipod System), today announced positive results from the first feasibility study of the Omnipod Horizon hybrid closed-loop system. The study demonstrated that the Omnipod automated glucose control 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. These data were presented today at the 10thInternational Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in Paris, France. Additional studies are underway to further validate the performance in adult and pediatric populations.
Study participants included 24 adults with type 1 diabetes. The 36-hour study1 included a modified version of Insulets Omnipod, a Dexcom continuous glucose sensor, and Insulets personalized model predictive control algorithm. Results showed use of the Companys hybrid closed-loop system was associated with significantly less time spent in hypoglycemic blood glucose range compared to ranges prior to the study. Key findings included patients achieving and remaining in the target blood glucose control range 69% of the time over the course of the study and maintaining target blood glucose control 90% of the time during the overnight period.
These very positive results, particularly in the overnight period, demonstrate the potential for the Omnipod Horizon System to improve clinical outcomes in patients with type 1 diabetes, said Dr. Bruce Buckingham, Professor of Pediatric Endocrinology at the Lucille Salter Packard Childrens Hospital, Stanford University, and Principal Investigator of the study. This is a safe system providing significant reductions in hypoglycemia both during the day and night, and the system made significant improvements in overnight glucose control, decreasing glucose variability and bringing fasting glucose values into range. These are very positive early findings and I think I speak for the entire team when I say I am excited to see how the Horizon system continues to perform in future clinical studies.
We are incredibly excited by the early results of this trial, which demonstrated excellent glucose control and tremendous promise to make a significant impact for patients, said Shacey Petrovic, President and Chief Operating Officer. Omnipod allows our users to feel more confident, and to experience improved quality of life and outcomes, and we are thrilled our Omnipod Horizon System is already demonstrating the ability to continue to make a significant impact on improving the lives of people with diabetes.
1 Buckingham BA, Pinsker JE, Christiansen, MP, Schneider J, Peyser TA, Dassau E, Bok Lee J, OConnor 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.
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 lifeand manage their diabeteswith 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.
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,Insuletseeks 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 features just two parts and a fully-automated cannula insertion.Insulet'sDelivery Systems business also partners with global pharmaceutical and biotechnology companies to tailor the Omnipod technology platform for the delivery of subcutaneous drugs across multiple therapeutic areas. Founded in 2000,Insulet Corporationis based inBillerica, Massachusetts. For more information, please visit:http://www.myomnipod.com.
This press release may contain forward-looking statements concerningInsulet'sexpectations, 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 onInsulet. There can be no assurance that future developments affectingInsuletwill 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 theSecurities and Exchange CommissiononFebruary 29, 2016in the section entitled "Risk Factors," and in its other filings from time to time with theSecurities 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.Insuletundertakes no obligation to publicly update or revise any forward-looking statements.
2017 Insulet Corporation. Omnipod, the Omnipod logo, Horizon, and the Horizon logo are trademarks or registered trademarks of Insulet Corporation. Dexcom and Dexcom G4 are registered trademarks of Dexcom, Inc. and used with permission. All rights reserved.
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Source: Insulet Corporation