A Prospective, Randomized, Parallel Crossover Study Demonstrating Subject Wearability and Usability of the I-Port Injection Port

This study has been completed.
Sponsor:
Collaborators:
Medstar Research Institute
Valeritas, Inc.
Information provided by:
Patton Medical Devices
ClinicalTrials.gov Identifier:
NCT00486109
First received: June 12, 2007
Last updated: March 10, 2008
Last verified: March 2008
  Purpose

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.


Condition Intervention
Type 1 Diabetes
Type 2 Diabetes
Device: I-Port(TM) Injection Port

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Study Assessing an Injection Port for Administration of Insulin

Resource links provided by NLM:


Further study details as provided by Patton Medical Devices:

Primary Outcome Measures:
  • Glycosylated albumin levels [ Time Frame: 7 weeks ]

Secondary Outcome Measures:
  • Participants' satisfaction evaluated with standard quality of life questionnaires and adverse events related to the study device including incidents of erythema > 2cm diameter, incidence of induration > 1cm dimater and incidence of suppuration. [ Time Frame: 7 weeks ]

Enrollment: 74
Study Start Date: October 2006
Study Completion Date: January 2007
  Eligibility

Ages Eligible for Study:   14 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 pre-prandial doses of SC insulin >30 IU per meal
  • Intake of any drug or herbal preparation which, in the evaluation of the PI, may interfere with the interpretation of clinical study results or that is known to cause clinically relevant interference with insulin action, glucose utilization or ability to detect or recover from hypoglycemia (e.g., systemic steroids)
  • History of known hypersensitivity to plastics or polymers
  • Treatment with any investigational drug within two (2) months prior to enrollment or during this study
  • Progressive fatal disease
  • History of malignancy within five (5) years of study entry(other than basal cell carcinoma)
  • Evidence of severe secondary complications of diabetes(neuropathy, nephropathy as evidenced by creatinine >1.5 mg/dL for females or >1.8 mg/dL for males, grade III or IV retinopathy or severe peripheral vascular disease)
  • Evidence of gastroparesis, orthostatic hypotension or hypoglycemia unawareness (autonomic neuropathy)
  • Myocardial infarction or stroke within the preceding six (6)months
  • Positive hepatitis B (HBsAg) and/or hepatitis C (Hep C AB)serology and/or positive HIV serology
  • History or presence of clinically significant cardiovascular, hepatic (as evidenced by ALT or AST >3 times the upper limit of normal), gastrointestinal, neurological or infectious disorders capable of altering the absorption, metabolism or elimination of drugs, or constituting a significant risk factor when using the study device
  • Anemia (hemoglobin levels <11 g/dL for females or <12 g/dL for males)
  • Pregnancy, lactation, or intention to become pregnant
  • Female subjects of childbearing potential practicing inadequate birth control (adequate birth control is defined as using oral
  • Regular alcohol intake greater than 18 units*/week, or subjects unwilling to stop alcohol for the duration of the study (* 1 unit = 8 g ethanol, ¼ liter of beer or 1 glass wine or 1 ounce of spirits)
  • PI or clinical site personnel directly affiliated with this study and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted
  • A lack of compliance (including the inability to maintain a minimum of 75% compliance with study device administration) or other reasons, which in the opinion of the PI may preclude the participation of the subject in the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00486109

Locations
United States, Georgia
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30309
United States, Nebraska
Diabetes and Endocrine Associates
Omaha, Nebraska, United States, 68131
United States, Texas
Texas Diabetes & Endocrinology
Austin, Texas, United States, 78731
Research Institute of Dallas
Dallas, Texas, United States, 75231
Diabetes and Glandular Disease Clinic
San Antonio, Texas, United States, 78729
Sponsors and Collaborators
Patton Medical Devices
Medstar Research Institute
Valeritas, Inc.
Investigators
Principal Investigator: Sherwyn Schwartz, M.D. Diabetes and Glandular Disease Clinic
Principal Investigator: Bruce Bode, M.D. Atlanta Diabetes Associates
Principal Investigator: Thomas Blevins, M.D. Texas Diabetes & Endocrinology
Principal Investigator: Stephen Aronoff, M.D. Research Institute of Dallas
Principal Investigator: Claire Baker, M.D. Diabetes and Endocrine Associates
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00486109     History of Changes
Other Study ID Numbers: PTN 012.1
Study First Received: June 12, 2007
Last Updated: March 10, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Patton Medical Devices:
Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 21, 2014