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

Patton Medical Devices

Status

Completed

Conditions

Type 1 Diabetes

Type 2 Diabetes

Treatments

Device: I-Port(TM) Injection Port

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00486109

PTN 012.1

Details and patient eligibility

About

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.

Enrollment

74 patients

Sex

All

Ages

14 to 70 years old

Volunteers

No Healthy Volunteers

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