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 @ 7:23 PM
Ignite Modification Date:
2025-12-24 @ 7:23 PM
NCT ID:
NCT01552603
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of type 1 diabetes mellitus for at least 1 year.
* Male or female subjects 21 to 65 years of age.
* Current use of an insulin pump.
* Willingness to follow all study procedures, including attending all clinic visits.
* Willingness to sign informed consent and HIPAA documents.
Exclusion Criteria:
* Pregnancy or Lactation: For women of childbearing potential: there is a requirement for a negative urine pregnancy test and for agreement to use contraception during the study and for at least 1 month after participating in the study. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence.
* Renal insufficiency (serum creatinine of 2.0 mg/dL or greater).
* Serum ALT or AST equal to or greater than 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as a serum albumin of less than 3.3 g/dL; or serum bilirubin of over 2.
* Adrenal insufficiency
* Hematocrit of less than or equal to 34%.
* A history of cerebrovascular disease or coronary artery disease regardless of the time since occurrence.
* Congestive heart failure, NYHA class III or IV.
* Diagnosis of 2nd or 3rd degree heart block or any arrhythmia judged by the investigator to be exclusionary.
* Any active infection.
* Visual impairment preventing reading of glucose meter values or continuous glucose monitoring device.
* Physical impairment impeding the ability to use a glucose meter or glucose monitoring device.
* Active foot ulceration.
* Severe peripheral arterial disease characterized by ischemic rest pain or severe claudication.
* Active alcohol abuse, substance abuse, or severe mental illness (as judged by the principal investigator).
* Active malignancy, except basal cell or squamous cell skin cancers.
* Major surgical operation within 30 days prior to screening.
* Seizure disorder.
* Chronic usage of any immunosuppressive medication (such as cyclosporine, azathioprine, sirolimus, or tacrolimus).
* Current administration of oral or parenteral corticosteroids.
* Use of an investigational drug within 30 days prior to screening.
* Bleeding disorder, treatment with warfarin, or platelet count below 50,000.
* Allergy to aspart insulin.
* Allergy to glucagon.
* Past history of pheochromocytoma or a family history of MEN 2, neurofibromatosis, or von Hippel-Lindau disease.
* Insulin resistance requiring more than 200 units per day.
* Need for uninterrupted treatment of acetaminophen.
* Intolerance of mild hypoglycemia (glucose 60-70 mg/dl).
* History of hypoglycemic unawareness.
* Insulin antibody level of ≥ 100 µUnits/ml.
* C peptide level of ≥0.5 ng/ml.
* Any concurrent illness, other than diabetes, that is not controlled by a stable therapeutic regimen.
* Any reason the principal investigator deems exclusionary
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT01552603
Study Brief:
Protocol Section:
NCT01552603