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
Darcy Keane
Lazar Partners
646-871-8487
Gil Chorbajian
Albany College of Pharmacy and Health Sciences
518-694-7394