Diabetes Research in Children Network (DirecNet)

Protocol: A Pilot Study to Evaluate the Safety of Terbutaline in Children with Type 1 Diabetes
Status: Closed
Start Date: 12/01/2007
End Date: 09/15/2008
Clinical Trial ID:  
Public Dataset:  

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

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This pilot study of 9 subjects ages 13-18 years was conducted to gain experience with the use of terbutaline in children with type 1 diabetes and to determine if there would be any unexpected side effects from use of the drug. In addition, the study collected data on the accuracy of a pediatric version of the DexCom SEVEN CGM with use of terbutaline. Subjects wore the CGM at home for one week and then were admitted to a research unit of the hospital overnight to start use of terbutaline (2.5 mg or 3.75 mg dose each night depending on the weight of the subject). Following the first admission, subjects used terbutaline at home for 3-4 weeks before returning for a second hospital admission. During each admission, side effects were monitored by taking blood samples, heart rate and blood pressure. Blood samples were also collected to assess accuracy of the CGM. Use of terbutaline was discontinued prior to discharge from the second admission and subjects were allowed to continue using the CGM at home for 1-2 weeks at the discretion of the study investigator.




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