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 @ 7:34 PM
Ignite Modification Date:
2025-12-24 @ 7:34 PM
NCT ID:
NCT00607503
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
* Age 12.0 years to less than 18.0 years
* HbA1c \<8.0%
* Use of basal: bolus insulin therapy with either an insulin pump or glargine with MDI of a short-acting insulin for at least 6 months (approximately 5 pump and 5 MDI users will be enrolled)
* Availability of home computer to download the CGM
* For females: not currently pregnant, negative pregnancy test, and not intending to become pregnant during the next 3 months
* Parent/guardian and subject understand the study protocol and agree to comply with it
* Informed Consent Form signed by the parent/guardian and Child Assent Form signed by the subject if required by IRB
Exclusion Criteria:
* Severe hypoglycemic event (seizure or coma) or diabetic ketoacidosis in the past 6 months
* Cardiac disease, including prolonged QT interval on EKG or pathologic arrhythmia
* An EKG will be done either prior to the CRC admission or during the CRC admission prior to the first dose of terbutaline
* Treatment for hypertension or blood pressure exceeding the 90th percentile for age and height
* Current treatment for a seizure disorder
* Asthma if treated with systemic or inhaled corticosteroids in the last 6 months or with a beta adrenergic agonist more than once a month
* Cystic fibrosis
* Use of MAO inhibitors, tricyclic antidepressants, or beta blockers
* Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
* Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian).
* Medical condition that in the judgment of the investigator might interfere with the completion of the protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT00607503
Study Brief:
Protocol Section:
NCT00607503