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

NCT00486109 | Completed

• 1 other identifier: PTN 012.1
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Type 1 Diabetes; Type 2 Diabetes

Keywords

Diabetes

Outcome Measures

Primary Outcomes (1)

• Glycosylated albumin levels

  7 weeks

Secondary Outcomes (1)

• 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.

  7 weeks

Interventions

I-Port(TM) Injection Port DEVICE

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Patton Medical Devices: lead
• Medstar Health Research Institute: collaborator
• Valeritas, Inc.: collaborator

Study Sites (5)

Atlanta Diabetes Associates

Atlanta, Georgia, 30309, United States

Location

Diabetes and Endocrine Associates

Omaha, Nebraska, 68131, United States

Location

Texas Diabetes & Endocrinology

Austin, Texas, 78731, United States

Location

Research Institute of Dallas

Dallas, Texas, 75231, United States

Location

Diabetes and Glandular Disease Clinic

San Antonio, Texas, 78729, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Vascular Access Devices

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 12, 2007
• First Posted: June 13, 2007
• Study Start: October 1, 2006
• Study Completion: January 1, 2007
• Last Updated: March 11, 2008

Record last verified: 2008-03

Locations

US (5)