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

Type 2 Diabetes Clinical Trial

Official title:

A Study Assessing an Injection Port for Administration of Insulin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00486109
• Other study ID #: PTN 012.1
• Status: Completed
• Phase: N/A
• First received: June 12, 2007
• Last updated: March 10, 2008
• Start date: October 2006
• Est. completion date: January 2007

Study information

• Verified date: March 2008
• Source: Patton Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 1 Diabetes
• Type 2 Diabetes

Intervention

Device:
• I-Port(TM) Injection Port

Locations

Country	Name	City	State
United States	Atlanta Diabetes Associates	Atlanta	Georgia
United States	Texas Diabetes & Endocrinology	Austin	Texas
United States	Research Institute of Dallas	Dallas	Texas
United States	Diabetes and Endocrine Associates	Omaha	Nebraska
United States	Diabetes and Glandular Disease Clinic	San Antonio	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Patton Medical Devices	Medstar Research Institute, Valeritas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycosylated albumin levels		7 weeks
Secondary	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