New Data Demonstrate Benefits of Insulet's Omnipod® System for People with Type 1 and Type 2 Diabetes
Two Publications in the
The large, multi-center retrospective study on which the publications were based showed that A1c (an important measure of blood glucose control) reduction was clinically meaningful and statistically significant for patients with type 1 diabetes at three months after starting on the Omnipod System. The study showed A1c levels decreased by 0.6% for patients previously on MDI therapy and were 0.5% lower compared to patients using traditional tubed insulin pumps. In patients with type 2 diabetes, A1c levels significantly decreased by 1.2% after three months of the Omnipod System use compared to prior treatment with MDI.
In addition to improvement in A1c levels, the study also showed the Omnipod System use was associated with significant reductions in daily insulin requirement and in the frequency and severity of reported hypoglycemic episodes in patients with type 1 and 2 diabetes.
"This study marks the first report of glycemic control among a large
cohort of patients treated with Omnipod in a real-world clinical
setting, with results comparable to those reported for multiple daily
insulin injections and other continuous subcutaneous infusion pumps,"
More than 900 patients were included in the study. Approximately 80% of the patients with type 1 diabetes were previously treated with MDI therapy and about 20% used traditional insulin pumps. The group of patients with type 2 diabetes all had previously used MDI. Results at three months included:
- Improved A1c levels: Type 1 diabetes patients, including the pediatric, adolescent and adult groups, showed significant (p < 0.001) decreases in A1c of 0.6% and 0.5% with the Omnipod System compared to MDI and traditional tubed pumps, respectively. Patients with type 2 diabetes using the Omnipod System had a 1.2% decrease in A1c compared to MDI.
- Reduced daily insulin requirement: A 16.4% reduction in the total daily dose of insulin was observed in patients with type 1 diabetes using the Omnipod System and a 27.5% reduction was reported for patients with type 2 diabetes.
- Fewer hypoglycemic episodes: Patients with type 1 diabetes reported that hypoglycemia decreased significantly by one episode per week (p < 0.001) with the Omnipod System treatment compared to previous treatments and that the severity of hypoglycemic episodes was also significantly lower. In patients with type 2 diabetes, the frequency of hypoglycemic episodes was 46.2% (p < 0.004) lower with the Omnipod System treatment, with similar reductions in severity of hypoglycemic episodes.
"Our mission is to change the way patients and providers manage
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 29, 2016 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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