A Prospective, Randomized, Parallel Crossover Study Demonstrating Subject Wearability and Usabili… (NCT00486109) | Clinical Trial Compass
CompletedNot Applicable
A Prospective, Randomized, Parallel Crossover Study Demonstrating Subject Wearability and Usability of the I-Port Injection Port
United States74 participantsStarted 2006-10
Plain-language summary
This study investigated wearability and usability of the I-PORT™ Injection Port (I-PORT™), a new disposable injection port through which prescribed medication is injected subcutaneously from a standard syringe or pen. Additional investigation compared subject opinion towards using the I-PORT™ device compared to standard injection therapy.
Who can participate
Age range14 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male and female subjects, 14-70 years of age, with type 1 and type 2 diabetes mellitus for a minimum of six (6) months
* Subjects must be utilizing a regimen of at least two (2)injections daily of either Novolin®, Humulin®, NovoLog®, Humalog® or Apidra® and no more than one (1) injection of Lantus® daily using a standard syringe or insulin pen
* Current regimen of intensified insulin therapy (defined as separate injections of basal and prandial insulin with at least three (3) insulin injections per day) for a minimum of three (3) months
* Body Mass Index \<35 kg/m2
* HbA1c ≤ 10 %
* If medications (other than oral anti-diabetic agents) in addition to insulin are taken at screening, the subject must be on a stable regimen as defined by continued use of the same dose of each medication for a period of at least three (3) months prior to study enrollment
* Subjects must be willing to provide written informed consent
Exclusion Criteria:
* Use of Continuous Subcutaneous Insulin Infusion (CSII) at any time within the preceding three (3) months
* History or current diagnosis of chronic diseases which in the view of the PI would interfere with adequate involvement in and completion of the requirements of the study
* Use of short term or chronic steroids within two (2) months of entry into the study or likelihood that same might be required during the conduct of the study
* Use of hydrochlorthiazide at doses \>25 mg daily
* Use of beta-blocker drugs
* Regular pr…