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:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-03-26 @ 3:21 PM
NCT ID:
NCT02181127
Eligibility Criteria:
Inclusion Criteria:
* Age 21 years or older with type 1 diabetes for at least one year.
* Otherwise healthy (mild chronic disease such as asthma, hypertension, and depression will be allowed if well controlled).
* Self-reported frequency of documented hypoglycemia (BG \< 60 mg/dl) of at least 2 times per week
* Partial hypoglycemic unawareness (inconsistent symptoms with BG \< 50 mg/dl) or hypoglycemic unawareness (minimal or no symptoms with BG \< 50 mg/dl)
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.
* Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception
* History of cystic fibrosis, pancreatitis, or other pancreatic disease other than type 1 diabetes
* End stage renal disease on dialysis (hemodialysis or peritoneal dialysis).
* Any known liver or biliary disease including cirrhosis, alcoholic liver disease, non-alcoholic fatty liver disease, non-alcoholic steatohepatitis, any form of viral hepatitis.
* Congestive heart failure (established history of CHF, paroxysmal nocturnal dyspnea, or orthopnea).
* Acute illness or exacerbation of chronic illness at the time of the study.
* Seizure disorder or history of hypoglycemic seizure in the last 1 year
* 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 (indicators would include symptoms such as psychosis, hallucinations, mania, and any psychiatric hospitalization in the last year).
* Current alcohol abuse (intake averaging \> 3 drinks daily in last 30 days) or substance abuse (any use within the last 6 months of controlled substances without a prescription).
* Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to RF interference.
* History of adverse reaction to glucagon (including allergy) besides nausea and vomiting.
* Unwilling or unable to completely avoid acetaminophen during the study period.
* Any factors that, in the opinion of the principal investigator, would interfere with the safe completion of the study procedures.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02181127
Study Brief:
Protocol Section:
NCT02181127