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