Status:
COMPLETED
A Pilot Study to Evaluate the Safety of Terbutaline in Children With Type 1 Diabetes
Lead Sponsor:
Jaeb Center for Health Research
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
12-18 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to gain experience with the use of terbutaline in children with T1D and to determine that there is not a frequent serious, unexpected, uncontrollable effect on short-term g...
Detailed Description
Approximately 10 children will be recruited from five centers in the United States to participate in this study. The data collected in this pilot study will be used to determine whether to proceed to ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00607503
Start Date
February 1 2008
End Date
September 1 2008
Last Update
September 5 2016
Active Locations (6)
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1
Division of Pediatric Endocrinology and Diabetes, Stanford University
Stanford, California, United States, 94305
2
Department of Pediatrics, Yale University School of Medicine
New Haven, Connecticut, United States, 06519
3
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
4
Jaeb Center for Health Research
Tampa, Florida, United States, 33647