Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-24 @ 9:54 PM
NCT ID:
NCT01014832
Eligibility Criteria:
Inclusion Criteria:
Individuals eligible for inclusion in the study are those who:
1. are male or female, 25 to 65 years of age;
2. are of any ethnic background;
3. meet the criteria for either population I or population II;
4. if a female of child-bearing potential will submit to a urine pregnancy test (UPT) at Visit 1;
5. can provide their previous 12 months of lab results (at least one set of blood count, kidney functions, and liver enzymes); and
6. read, understand, and sign an informed consent document which contains a Health Information Portability and Accountability Act (HIPAA) authorization after being advised of the nature of the study.
Population I inclusion criteria:
Individuals eligible for inclusion in population I are those who:
1. meet the standard criteria for enrollment in the study;
2. have been clinically diagnosed compatible with Type-2 diabetes for at least 1 year;
3. take insulin injections for the past 6 months;
4. have or have not been using an oral agent within the past 6 months;
5. have sufficient medical insurance coverage to cover intensive insulin therapy including Lantus® and Humalog®/Novolog® as well as test-strips cost for testing their blood glucose levels at least 4 times per day;
6. are willing to stop anti-diabetic agents (except Metformin);
7. are willing to accept intensive insulin therapy with at least 4 daily insulin injections;
8. consistently record their glucose measurements and insulin doses in a log book and have their previous readings ready for review; and
9. have a Hemoglobin-A1c (HbA1c) of 7.6% or greater, to be drawn at Visit 1.
Population II inclusion criteria:
Individuals eligible for inclusion in population II are those who:
1. meet the standard criteria for enrollment in the study;
2. have been clinically diagnosed compatible with Type-1 diabetes for at least 1 year;
3. treated with both long acting insulin analog (ie, Insulin Glargine) and short acting insulin analog (ie, Insulin Lispro or Insulin Aspart) with a total daily insulin dose of 25 units or more
4. are currently using carbohydrate counting in their regimen or have been trained to employ this technique during the last 2 years;
5. consistently record their glucose measurements and insulin doses in a log book and have their previous readings for review; and
6. have a HbA1c of 7.6% or greater, to be drawn at Visit 1.
Exclusion Criteria:
Individuals excluded from participation in the study are those who:
1. have a history of greater than 2 episodes of severe hypoglycemia (See Section 5.4) in the past year or hypoglycemic unawareness;
2. have a significant physical, psychological, or cognitive impairment that would prohibit adherence to an intensive insulin therapy program;
3. have any severe cardiovascular disease including a history of congestive heart failure (New York Heart Association \[NYHA\] 3 or 4), unstable angina, myocardial infarction or stroke that occurred within 6 months prior to enrollment
4. have a history of severe anemia with a hematocrit less than 25% in women or 30% in men;
5. have a history of renal disease (ie, serum creatinine level greater than 2.0 mg/dl);
6. have a history of active cancer or cancer in the past 2 years (except non-melanoma skin cancer);
7. are receiving chemotherapy or radiation therapy;
8. have a history of significant liver disease including cirrhosis or elevated liver function tests (AST and ALT) greater than 3 times the upper limit of normal values;
9. have a body mass index (BMI) greater than 45 kg/m2; and/or
10. are pregnant, plan to become pregnant during the study period, or are breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
65 Years
Study:
NCT01014832
Study Brief:
Protocol Section:
NCT01014832