A Pilot Study to Evaluate the Safety of Terbutaline in Children With Type 1 Diabetes

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

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 glycemic control. Some information also will be obtained with regard to whether terbutaline, in the dosing being used in the study, is sufficiently well tolerated to expect that adherence will be satisfactory in a large randomized trial. In addition, this pilot study will provide data on the accuracy of a continuous glucose monitor during terbutaline use to verify that the drug does not impact on sensor function.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jaeb Center for Health Research
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Terbutaline

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