Device a "Viable Alternative" to Standard Injections - 69% of Patients Report i-port(R) is Helpful in the Management of Their Diabetes
AUSTIN, Texas, Sept. 17 /PRNewswire/ -- In a clinical trial comparing the i-port(R) (a small, disposable injection port about the size of a quarter) with standard injections in people with type 1 and type 2 diabetes, participants' differences in glycosylated albumin was not significantly different. The new data appeared in an article published in the current issue (Summer, 2008) of Diabetes Spectrum, a peer-reviewed journal of the American Diabetes Association. Glycosylated albumin is a direct measure of short term glucose in blood protein. Based on these results, the authors conclude that the utility and efficacy of administering multiple doses of insulin through a single i-port(R) device is a viable alternative to standard injections. View the complete abstract and/or purchase the feature article at http://spectrum.diabetesjournals.org/cgi/content/abstract/21/3/197.
"Our study demonstrates that delivering insulin via the i-port(R) provides the same therapeutic benefits as standard injections," said lead investigator Dr. Thomas Blevins of Texas Diabetes and Endocrinology in Austin, Texas. "This is especially significant for people with diabetes who struggle with adherence and need an alternative to the multiple daily skin punctures required by standard injections."
The prospective, randomized, controlled, open-label crossover study enrolled 74 patients with diabetes being treated with daily insulin injections at five trial sites. Participants were randomly assigned to two of three injection treatment regimens including standard injection, injecting through a single i-port(R) device, and injecting through two separate i-port(R) devices with each regimen lasting three weeks. Patients using the single i-port(R) regimen injected both regular human or rapid-acting insulin and LANTUS(R) through the same device (separating the dose of LANTUS(R) from the regular human or rapid acting insulin by at least 60 minutes). Participants using the dual i-port(R) regimen injected each type of insulin through two separate devices. Participants were evaluated by measurements of glycosylated albumin and study questionnaires. The results were not significantly different between the three treatment regimens (P = 0.99 for standard injection vs. single i-port(R) and P = 0.97 for single i-port(R) vs. dual i-port(R)). Fifty of 72 participants (69.4%) reported that the i-port(R) was useful and helpful in the management of their diabetes.
ABOUT the i-port(R) Injection Port
The i-port(R) Injection Port is a prescription only device cleared by the FDA in September 2005, for use by people requiring multiple daily, subcutaneous injections of physician-prescribed medications, including insulin. The i-port(R) may be a helpful treatment delivery tool for anyone who wants to minimize the intrusion of daily injections.
The i-port(R) should not be worn for longer than 72 hours. The most serious risks when using the i-port(R) include infection and the potential for poor medication delivery if not properly applied. For people with diabetes, the poor medication delivery may result in abnormally high or low blood sugar levels. If you experience these or any other problems when using the i-port(R), tell your doctor.
About Patton Medical Devices
Headquartered in Austin, Texas, Patton Medical Devices is the manufacturer of the i-port(R) Injection Port. For people taking injection therapy who want to minimize the intrusion of injections on daily life, the i-port(R) is the only product of its kind conceived by a person with diabetes that offers a simple, convenient way to eliminate the need to puncture the skin with each dose of medication. The i-port(R) lets patients focus on living their lives instead of the challenges associated with the next shot. For more information about Patton Medical Devices, its products and services, visit www.i-port.com or www.pattonmd.com.
CONTACT: Doug Hochstedler, +1-212-798-9724,
email@example.com, or Nicole Carp, +1-212-798-9753,
Web site: http://spectrum.diabetesjournals.org/cgi/content/abstract/21/3/197/