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The investigators hypothesize 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).
In this study, a minimum of 16 youth with type 1 diabetes will be recruited. All subjects must have been diagnosed with type 1 diabetes 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 Diabetes Research in Children Network 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Subjects complete the same exercise routine, however no treatment is given at 9:00pm. |
|
| Terbutaline | Experimental | Subjects complete same exercise routine. At 9:00pm, an oral dose of 2.5 mg of Terbutaline is administered. |
|
| 20% Basal Insulin Reduction | Experimental | All subjects complete the same exercise session. At 9:00pm, subject's basal rate is decreased by 20% for six hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Terbutaline | Drug | Oral (2.5mg) one time administration at 9:00pm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood Glucose Nadir | BG nadir overnight after intervention | overnight hours |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Nighttime Glucose Levels <80 | 9:00pm to 6:00am | |
| Percent of Nighttime Glucose Levels <70 | 10:00pm to 6:00am | |
| Percent of Nighttime Glucose Levels >250 mg/dl |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rosanna Fiallo-Scharer, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Davis Center | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20650471 | Derived | Taplin CE, Cobry E, Messer L, McFann K, Chase HP, Fiallo-Scharer R. Preventing post-exercise nocturnal hypoglycemia in children with type 1 diabetes. J Pediatr. 2010 Nov;157(5):784-8.e1. doi: 10.1016/j.jpeds.2010.06.004. Epub 2010 Jul 21. |
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no notes
Recruited from the Barbara Davis Center pediatric population
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| ID | Title | Description |
|---|---|---|
| FG000 | Control First, Then Terbutaline, Then 20% Basal Reduction | Subjects complete the same exercise routine. No treatment is given during the Control night, Terbutaline is given at 9pm during the Terbutaline night, a 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night. |
| FG001 | Terbutaline First, Then 20% Basal Reduction, Then Control | Subjects complete the same exercise routine. No treatment is given during the Control night, Terbutaline is given at 9pm during the Terbutaline night, a 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night. |
| FG002 | 20% Basal Reduction First, Then Control, Then Terbutaline | Subjects complete the same exercise routine. No treatment is given during the Control night, Terbutaline is given at 9pm during the Terbutaline night, a 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Subjects | Subjects complete the same exercise routine. Subjects serve as there own control and participate in all interventions. No treatment is given during the Control night, Terbutaline is given at 9pm during the Terbutaline night, a 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Percent of Nighttime Glucose Levels <80 | Posted | Number | percentage of overnight glucose levels | 9:00pm to 6:00am |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Study Subjects | Subjects complete the same exercise routine. Subjects serve as there own control and participate in all interventions. No treatment is given during the Control night, Terbutaline is given at 9pm during the Terbutaline night, a 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. H Peter Chase | UColorado | 303-724-2323 | peter.chase@ucdenver.edu |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D009043 | Motor Activity |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D013726 | Terbutaline |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| 20% basal insulin reduction | Other | Basal insulin rate is reduced by 20% the normal (home dose) for six hours. |
|
|
| Control | Other | No treatment is given for the study. This arm is for comparison with the two intervention arms. |
|
|
| 10:00pm to 6:00am |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Percent of Nighttime Glucose Levels <70 | Posted | Number | percentage of nighttime glucose values | 10:00pm to 6:00am |
|
|
|
| Secondary | Percent of Nighttime Glucose Levels >250 mg/dl | Posted | Number | percentage of overnght glucose values | 10:00pm to 6:00am |
|
|
|
| Primary | Blood Glucose Nadir | BG nadir overnight after intervention | Posted | Mean | Standard Deviation | mg/dl | overnight hours |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Control Arm | during control intervention night | 0 | 16 | 0 | 16 |
| EG002 | Terbutaline Arm | During turbutaline intervention night | 0 | 16 | 0 | 16 |
| EG003 | 20% Basal Reduction Arm | During 20% basal reduction night | 0 | 16 | 0 | 16 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |
| D000588 |
| Amines |