A Study Assessing an Injection Port for Administration of Insulin
- Thomas Blevins, MD,
- Sherwyn L. Schwartz, MD,
- Bruce Bode, MD,
- Stephen Aronoff, MD,
- Claire Baker, MD,
- Kay T. Kimball, PhD,
- Ronald B. Harrist, PhD,
- Chris Donnelly,
- Lauren C. Burns and
- Anna M. Wooldridge
- Address correspondence to Chris Donnelly, Patton Medical Devices, 3108 North Lamar Blvd, Austin, Texas 78705
Objective. To compare an injection port (I-Port), a disposable device through which multiple doses of insulin may be injected, to standard multiple dose insulin administration.
Design. Prospective, randomized crossover study.
Methods. Seventy-four patients with diabetes being treated with daily injections of insulin were recruited at five clinical sites. The patients were randomly assigned to two of three treatment regimens: 1) standard injection (SI), 2) a single I-Port device, or 3) two separate I-Port devices (Dual I-Port) with each treatment regimen lasting for 3 weeks. Participants in the single I-Port regimen injected both regular human or rapid-acting insulin and insulin glargine through the same device, whereas participants in the Dual I-Port regimen injected each type of insulin through two separate devices. Participants were evaluated by measurements of glycosylated albumin and study questionnaires.
Results. Participants' glycosylated albumin was not significantly different between SI, single I-Port, and Dual I-Port treatment regimens (P = 0.99 for SI vs. single I-Port and P = 0.97 for single I-Port vs. Dual I-Port). Fifty of 72 participants (69.4%) reported that the I-Port was useful and helpful in the management of their diabetes.
Conclusions. This study supports the utility and efficacy of administering multiple doses of insulin through a single I-Port device and concludes that the I-Port is a viable alternative to SI.
Thomas Blevins, MD, is the chief executive officer and director at Texas Diabetes & Endocrinology, in Austin. Sherwyn L. Schwartz, MD, is chief executive officer and chief medical officer at the Diabetes and Glandular Disease Clinic Research Association in San Antonio, Texas. Bruce Bode, MD, is a diabetes specialist at Atlanta Diabetes Associates in Georgia. Stephen Aronoff, MD, is the director at the Research Institute of Dallas in Texas. Claire Baker, MD, is a diabetes specialist at Diabetes and Endocrine Associates in Omaha, Nebr. Kay T. Kimball, PhD, is co-founder and owner of Statistical Design and Analysis in Austin, Texas. Ronald B. Harrist, PhD, is an associate professor of biostatistics at the University of Texas School of Public Health in Austin. Chris Donnelly is the executive vice president and chief financial officer, and Lauren C. Burns and Anna M. Wooldridge are clinical affairs associates at Patton Medical Devices, LP, in Austin, Texas.
Note of disclosure: Drs. Blevins, Bode, and Aronoff have received research support from Patton Medical Devices, which manufactures the I-Port device. The research company headed by Dr. Schwartz has received research support from numerous pharmaceutical and medical device companies, including Patton Medical Devices (complete list on file). Drs. Kimball and Harrist are paid biostatistical consultants for Patton Medical Devices. Mr. Donnelly, Ms. Burns, and Ms. Woolridge are employed by and stock shareholders in Patton Medical Devices. Mr. Donnelly is also a member of the company's board of managers.
- American Diabetes Association