SOURCE: Insulet Corporation

February 01, 2010 11:00 ET

Efficacy and Safety Demonstrated by the OmniPod Insulin Management System in Retrospective Study

Tubing-Free Insulin Pump Shown to Improve A1C and Overcome Obstacles to Pump Therapy

BEDFORD, MA--(Marketwire - February 1, 2010) - Albany College of Pharmacy and Health Sciences and The Endocrine Group researchers have concluded that the OmniPod® Insulin Management System significantly improved blood glucose control in diabetes patients who previously received insulin through multiple daily injections. The retrospective study results were published in the latest issue of Infusystems USA, in a study titled, 'Clinical Experience with a Tubing-Free Insulin Pump System.'

Lead investigator, Michael P. Kane, Pharm.D., FCCP, BCPS, Professor of Pharmacy Practice at Albany College of Pharmacy and Health Sciences, reported that study results showed that after one year using the OmniPod System, patients who previously received insulin through multiple daily injections decreased their average A1C levels by 0.49%, a statistically significant difference. A1C levels, also known as HbA1C or glycated hemoglobin levels, measure a patient's average blood glucose control over a sustained period. The study also demonstrated that 25.5% of patients using the OmniPod System reduced their A1C below 7%, compared to 5.7% of patients prior to use of the OmniPod System. The American Diabetes Association recommends most patients keep their A1C levels below 7%.

"This study demonstrates the benefits of a tubing-free insulin pump, which can help patients overcome their fear of insertion sets or unsightly tubing and achieve the clinical benefits of insulin pump therapy," said study investigator Jill M. Abelseth, M.D., FACE of The Endocrine Group. "The high patient acceptance, improved glycemic control and overall safety demonstrated in this study support the use of the OmniPod System for diabetes patients aiming for improved glycemic control."

The OmniPod System was also found to be safe, as there were no significant differences in episodes of diabetic ketoacidosis (DKA) or hypoglycemia requiring assistance among patients during the one-year OmniPod System use compared to the year prior to starting therapy. The overall acceptance rate for the OmniPod System in the study was 92.2%.

The study also reviewed 12 patients who switched to the OmniPod System from a conventional insulin pump and showed a reduction in average one-year A1C values by 0.2%. Researchers noted that although this difference was not statistically significant, the results were encouraging and the lack of statistical significance may be attributable to the small sample size of this study. A larger study to evaluate the A1C improvements in this patient population is recommended.

ABOUT THE STUDY

This retrospective study, approved by Albany College of Pharmacy and Health Sciences' Institutional Review Board, consisted of 59 diabetes patients initiating continuous insulin infusion therapy with the OmniPod Insulin Management System who previously received multiple daily insulin injections or used another insulin pump device.

Patients were initially identified through a computerized text search of medical records using the terms 'insulin pump' and 'OmniPod.' Records were subsequently reviewed to determine patients who initiated use of the OmniPod System at least one year prior. A collection form was developed and utilized to collect baseline patient demographic information.

Each patient served as her/her own control. Paired t-tests were utilized for statistical analysis with p-values less that 0.05 considered statistically significant.

About the OmniPod Insulin Management System

The OmniPod Insulin Management System is the world's first tubing-free insulin pump. The OmniPod System offers people living with insulin-requiring diabetes all the benefits of insulin pump therapy, with unprecedented freedom, comfort and ease. The OmniPod System has just two components: the small, discreet, watertight Pod, worn almost anywhere on the body to hold and deliver insulin; and the PDM (Personal Diabetes Manager), a hand-held device that communicates wirelessly to program the Pod, calculates suggested doses and has a built-in FreeStyle® blood glucose meter. The OmniPod System is manufactured by Insulet Corporation (NASDAQ: PODD) of Bedford, MA. For more information, please visit: www.myomnipod.com

About The Endocrine Group, LLP

The Endocrine Group provides the best possible care in a cost effective, efficient manner while maintaining a patient-friendly, compassionate environment. Toward this goal The Endocrine Group integrates patient care with ancillary support staff best suited to for all needs. The Endocrine Group manages a wide spectrum of endocrine disorders, including diabetes, osteoporosis, thyroid disorders, pituitary and adrenal problems, disorders of calcium metabolism, and a variety of other endocrine abnormalities. The Endocrine Group is located in Albany, NY. For more information please visit www.theendocrinegroup.com.

About Albany College of Pharmacy and Health Sciences

Founded in 1881, Albany College of Pharmacy and Health Sciences is a private, independent institution committed to the advancement of health. The College has academic programs and research activities spanning the full spectrum of pharmacy and health sciences -- from drug discovery to patient care. Nearly 1,600 ACPHS students are pursuing a wide range of career pathways in health related fields through degree programs in pharmacy, pharmaceutical sciences, biomedical technology and health and human sciences. The College's main campus is located in Albany, New York; its satellite campus is in Colchester, Vermont. For more information, please visit www.acphs.edu.

Contact Information

  • Media Contacts:

    Erich Sandoval
    Lazar Partners
    917-497-2867
    Email Contact

    Darcy Keane
    Lazar Partners
    646-871-8487
    Email Contact

    Gil Chorbajian
    Albany College of Pharmacy and Health Sciences
    518-694-7394
    Email Contact