Insulet Corporation 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
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The data are from a study of 38,778 patients in
"These data represent a large portion of our
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
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
"The ability for
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
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.
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 and Omnipod 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.
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