Insulet Presents Real-World Clinical Data On The Use Of Its Omnipod Insulin Management System In Approximately 39,000 Patients Using A Cloud-Based Data Management System
Data Demonstrate Use of the Omnipod System and Insulet Provided Glooko is Associated with Favorable Mean Blood Glucose Levels Compared to U.S. National Averages
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 presented real-world clinical data at the Congress of the European Association for the Study of Diabetes (EASD) in Lisbon, Portugal.
The data are from a study of 38,778 patients in the United States with type 1 and type 2 diabetes who received insulin using the Omnipod System with at least three months of data downloaded using Insulet Provided Glooko (a cloud-based diabetes data management system). The data demonstrated this use was associated with frequent fingerstick blood glucose testing through the integrated Abbott FreeStyle® glucose meter and high usage of the advanced features of the Omnipod System.1 These findings provide meaningful insights into patient behaviors and clinical outcomes that can be used to positively impact treatment decisions.
“These data represent a large portion of our U.S. customer base and provide valuable insights into patient behaviors and clinical outcomes in the real-world setting,” said Dr. Trang Ly, Vice President and Medical Director at Insulet. “Our partnership with Glooko provides meaningful input into self-management patterns and blood glucose profiles, which inform our future innovation and allow clinicians to better care for their patients. We are excited about these positive results further evidencing the many benefits of our Omnipod System and we look forward to presenting additional details at the EASD meeting.”
Insulet will present at its sponsored symposium at the EASD meeting on Thursday, September 14, 2017 at 7 p.m. local time.
A number of clinical variables were analyzed which provided a valuable benchmark regarding Omnipod user insulin management behaviors. The average glucose level was 186 mg/dL, which is equivalent to an estimated HbA1C of 8.1%. This compares favorably to recent reports of U.S. data from the Type 1 Diabetes Exchange Registry demonstrating an average HbA1C of 8.4%2. In addition, the data demonstrated advanced pump feature use (e.g., extended bolus feature) occurred in 36% of all patients.
A subset of 3,394 people in the study used a continuous glucose monitor (CGM) in addition to the Omnipod System and additional variables were analyzed for this group. A larger percentage of CGM plus Omnipod users required less insulin and spent more time in the normal range (70-180 mg/dL), and less time in the hypoglycemic and hyperglycemic ranges. A much higher percentage (65%) of the CGM plus Omnipod group used advanced Omnipod System features, supporting the potential for additional blood glucose data to positively impact insulin management behaviors, especially when combined with the use of the Omnipod System.
These initial data are promising and there is the potential for additional areas of invaluable insight in different markets, notably Europe, and specifically once Insulet assumes responsibility for the distribution and commercial support of Omnipod in Europe on July 1, 2018. Establishing this direct European presence will allow the Company to be closer to the local diabetes community to deepen its understanding of customer behaviors and incorporate these learnings to drive strong customer support and innovation.
“The ability for Insulet to deliver this level of insight through real-world data in patients using an insulin pump, continuous glucose monitoring and a data management system is impressive and represents a very promising platform for the development of future innovation,” said Professor Eric Renard, Head of Department, Department of Endocrinology, Diabetes and Nutrition, Montpellier University Hospital, France.
1 Schütt M, et al. Is the frequency of self-monitoring of blood glucose related to long-term metabolic control? Multicenter analysis including 24,500 patients from 191 centers in Germany and Austria. Exp Clin Endocrinol Diabetes. 2006.
2 Miller KM, et al. Current state of type 1 diabetes treatment in the US: updated data from the T1D Exchange clinic registry. Diabetes Care. 2015;38(6)971-978.
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. Insulet seeks to expand the use of insulin pump therapy with its Omnipod Insulin Management System among people with insulin-dependent diabetes. The Omnipod System 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 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.
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.
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