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 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT01684956
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years or older with clinical type 1 diabetes for at least one year
* 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).
* Ability to consume a sufficient amount of carbohydrates over 2-3 hours to cover 5 units of rapid acting insulin
* Stimulated C-peptide \<0.1 nmol/L at 90 minutes after liquid mixed meal tolerance test.
Exclusion Criteria:
* Unable to provide informed consent
* Unable to comply with study procedures
* Current participation in another diabetes-related clinical trial other than one that is primarily observational in nature. Potential subjects enrolled in trails of passive monitoring equipment, such as continuous glucose monitors (CGMs), are not excluded
* Inadequate venous access as determined by study nurse or physician at time of screening
* Pregnancy
* Hemoglobin less than 13.5 for men and less than 12 for women
* History of pheochromocytoma (fractionated metanephrines will be tested in patients with history increasing the risk for a catecholamine secreting tumor to include episodic or treatment refractory hypertension defined as requiring 4 or more medications to achieve normotension, paroxysms of tachycardia, pallor, or headache, or personal or family history of MEN 2A, MEN 2B, neurofibromatosis, or von Hippel-Lindau disease)
* History of adverse reaction to glucagon (including allergy) besides nausea and vomiting
* History of adrenal disease or tumor
* Hypertension (blood pressure \> 160/100 mm/Hg at screening or day of study visit
* History of allergy to aspirin or any history of aspirin intolerance, including Reye's syndrome, or gastric ulcer or bleeding associated with salicylates.
* Blood dyscrasia or bleeding diathesis, such as hemophilia, Von Willebrand's disorder, and idiopathic thrombocytopenic purpura (ITP)
* Peptic Ulcer
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01684956
Study Brief:
Protocol Section:
NCT01684956