Use of Terbutaline or a Reduction in Basal Insulin in the Prevention of Nocturnal Hypoglycemia
The investigators hypothesize that that the use of an oral dose of Terbutaline or a 20% basal reduction will be able to prevent nocturnal hypoglycemia after an afternoon exercise session. This is a randomized three period cross-over study including treatment with Terbutaline, a 20% basal reduction for six hours, or no treatment (control).
Type 1 Diabetes
Other: 20% basal insulin reduction
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Effect of Using Terbutaline or a Reduction in Basal Insulin Infusion as a Therapeutic Agent to Prevent Delayed Nocturnal Hypoglycemia in Children and Adolescents With Type 1 Diabetes|
- Mean blood glucose values. [ Time Frame: 10:00pm to 6:00am ] [ Designated as safety issue: No ]
- Time spent with nocturnal glucose levels <70 and <60 mg/dl [ Time Frame: 10:00pm to 6:00am ] [ Designated as safety issue: No ]
- Incidence of hypoglycemia (BG< 70 mg/dl) [ Time Frame: 10:00pm to 6:00am ] [ Designated as safety issue: No ]
- Number of episodes of hyperglycemia (values >180 mg/dl) [ Time Frame: 10:00pm to 6:00am ] [ Designated as safety issue: No ]
|Study Start Date:||March 2008|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Active Comparator: Control
Subjects complete the same exercise routine, however no treatment is given at 9:00pm.
No treatment is given for the study. This arm is for comparison with the two intervention arms.
Other Name: No intervention
Subjects complete same exercise routine. At 9:00pm, an oral dose of 2.5 mg of Terbutaline is administered.
Oral (2.5mg) one time administration at 9:00pm
Other Name: β2-adrenergic agonist
Experimental: 20% Basal Reduction
All subjects complete the same exercise session. At 9:00pm, subject's basal rate is decreased by 20% for six hours.
Other: 20% basal insulin reduction
Basal insulin rate is reduced by 20% the normal (home dose) for six hours.
Other Name: 80% basal insulin
In this study, a minimum of 16 youth with type 1 diabetes will be recruited. All subjects must have been diagnosed with T1D for at least one year and on an insulin pump for at least one month. Subjects are between the ages of 10 and 17 years, inclusive, have an HbA1c less than 10.0% and normal thyroid function. Subjects can not have had a severe hypoglycemic episode in the last three months, any other illness or treatment that may affect the wearing of a continuous glucose monitor or the completion of the study as determined by the investigator. Subjects may not use drugs containing pseudoephedrine within 48 hours of the study visits.
This study consists of three overnight visits at the Clinical Translational Research Center. Meals eaten during the study will be consistent for each of the three visits.
Subjects will participate in a standardized afternoon exercise session on a treadmill as has been done in previous DirecNet studies. Exercise will begin at 4pm and must be completed by 6pm. Dinner will be eaten at the end of the exercise.
At 9pm, treatment will be given as determined by the randomization group the subject is assigned to. The treatment includes either an oral dose of 2.5mg Terbutaline, a 20% basal reduction for six hours or no treatment as the control. Blood glucose levels will be measured every 30 minutes until 6am.
|United States, Colorado|
|Barbara Davis Center|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Rosanna Fiallo-Scharer, MD||University of Colorado, Denver|