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 @ 2:32 PM
Ignite Modification Date:
2025-12-24 @ 2:32 PM
NCT ID:
NCT01762059
Eligibility Criteria:
Inclusion Criteria:
* Age 21 years or older with type 1 diabetes for at least one year
* Stimulated C-peptide \< 0.1 nmol/L at 90 minutes after liquid mixed meal by the DCCT protocol
* Diabetes managed using an insulin infusion pump and rapid- or very-rapid-acting insulins including insulin aspart (NovoLog), insulin lispro (Humalog), and insulin glulisine (Apidra) for at least three months prior to enrollment
* Otherwise healthy (mild chronic disease such as asthma, hypertension, and depression will be allowed if well controlled)
Exclusion Criteria:
* Unable to provide informed consent
* Unable to comply with study procedures
* Total daily dose (TDD) of insulin that is \> 1.5 U/kg
* Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception.
* Hypoglycemia unawareness (self-reported lack of hypoglycemia symptoms when BG is \< 50 mg/dl)
* End stage renal disease on dialysis (hemodialysis or peritoneal dialysis).
* Any known history of coronary artery disease (CAD)
* Abnormal EKG suggestive of coronary artery disease or increased risk of malignant arrhythmia
* Congestive heart failure (established history of CHF, paroxysmal nocturnal dyspnea, or orthopnea).
* History of TIA or stroke.
* History of pheochromocytoma. Fractionated metanephrines will be tested in patients with history increasing the risk for a catecholamine secreting tumor
* Untreated or inadequately treated mental illness
* Current alcohol abuse or substance abuse
* Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to RF interference.
* Use non-insulin, injectable anti-diabetic medications or oral anti-diabetic medications
* History of adverse reaction to glucagon (including allergy) besides nausea and vomiting
* Unwilling or unable to completely avoid acetaminophen
* ALT \> 3-fold upper limit of normal
* Albumin \< 3 g/dl
* Body mass index less than18 or greater than 35
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT01762059
Study Brief:
Protocol Section:
NCT01762059