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Use of Terbutaline or a Reduction in Basal Insulin in the Prevention of Nocturnal Hypoglycemia

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ClinicalTrials.gov Identifier: NCT00974051
Recruitment Status : Completed
First Posted : September 10, 2009
Results First Posted : October 11, 2013
Last Update Posted : October 11, 2013
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 1 Diabetes
Interventions Drug: Terbutaline
Other: 20% basal insulin reduction
Other: Control
Enrollment 16
Recruitment Details Recruited from the Barbara Davis Center pediatric population
Pre-assignment Details no notes
Arm/Group Title Control First, Then Terbutaline, Then 20% Basal Reduction Terbutaline First, Then 20% Basal Reduction, Then Control 20% Basal Reduction First, Then Control, Then Terbutaline
Hide Arm/Group Description 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. 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. 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.
Period Title: Overall Study
Started 6 4 6
Completed 6 4 6
Not Completed 0 0 0
Arm/Group Title All Study Subjects
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
<=18 years
16
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
13.3  (1.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
7
  43.8%
Male
9
  56.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants
16
1.Primary Outcome
Title Blood Glucose Nadir
Hide Description BG nadir overnight after intervention
Time Frame overnight hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Arm Terbutaline Arm 20% Basal Reduction Arm
Hide Arm/Group Description:
No treatment is given during the Control night. Glucose levels from 9 pm to 6 am are analyzed.
2.5 mg oral terbutaline is given at 9pm during the Terbutaline night. Glucose levels from 9 pm to 6 am are analyzed.
Subjects complete the same exercise routine. A 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night. Glucose levels from 9 pm to 6 am are analyzed.
Overall Number of Participants Analyzed 16 16 16
Mean (Standard Deviation)
Unit of Measure: mg/dl
128  (58) 189  (60) 162  (65)
2.Secondary Outcome
Title Percent of Nighttime Glucose Levels <80
Hide Description [Not Specified]
Time Frame 9:00pm to 6:00am
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Arm Terbutaline Arm 20% Basal Reduction Arm
Hide Arm/Group Description:
No treatment is given during the Control night. Glucose levels from 9 pm to 6 am are analyzed.
2.5 mg oral terbutaline is given at 9pm during the Terbutaline night. Glucose levels from 9 pm to 6 am are analyzed.
Subjects complete the same exercise routine. A 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night. Glucose levels from 9 pm to 6 am are analyzed.
Overall Number of Participants Analyzed 16 16 16
Measure Type: Number
Unit of Measure: percentage of overnight glucose levels
6.6 0 4.9
3.Secondary Outcome
Title Percent of Nighttime Glucose Levels <70
Hide Description [Not Specified]
Time Frame 10:00pm to 6:00am
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Arm Terbutaline Arm 20% Basal Reduction Arm
Hide Arm/Group Description:
No treatment is given during the Control night. Glucose levels from 9 pm to 6 am are analyzed.
2.5 mg oral terbutaline is given at 9pm during the Terbutaline night. Glucose levels from 9 pm to 6 am are analyzed.
Subjects complete the same exercise routine. A 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night. Glucose levels from 9 pm to 6 am are analyzed.
Overall Number of Participants Analyzed 16 16 16
Measure Type: Number
Unit of Measure: percentage of nighttime glucose values
1.7 0 0.3
4.Secondary Outcome
Title Percent of Nighttime Glucose Levels >250 mg/dl
Hide Description [Not Specified]
Time Frame 10:00pm to 6:00am
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Arm Terbutaline Arm 20% Basal Reduction Arm
Hide Arm/Group Description:
No treatment is given during the Control night. Glucose levels from 9 pm to 6 am are analyzed.
2.5 mg oral terbutaline is given at 9pm during the Terbutaline night. Glucose levels from 9 pm to 6 am are analyzed.
Subjects complete the same exercise routine. A 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night. Glucose levels from 9 pm to 6 am are analyzed.
Overall Number of Participants Analyzed 16 16 16
Measure Type: Number
Unit of Measure: percentage of overnght glucose values
30.2 63.5 41.7
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Study Subjects Control Arm Terbutaline Arm 20% Basal Reduction Arm
Hide Arm/Group Description 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. during control intervention night During turbutaline intervention night During 20% basal reduction night
All-Cause Mortality
All Study Subjects Control Arm Terbutaline Arm 20% Basal Reduction Arm
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Study Subjects Control Arm Terbutaline Arm 20% Basal Reduction Arm
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/16 (0.00%)   0/16 (0.00%)   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Study Subjects Control Arm Terbutaline Arm 20% Basal Reduction Arm
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/16 (0.00%)   0/16 (0.00%)   0/16 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. H Peter Chase
Organization: UColorado
Phone: 303-724-2323
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00974051     History of Changes
Other Study ID Numbers: 07-0392
First Submitted: September 9, 2009
First Posted: September 10, 2009
Results First Submitted: September 17, 2012
Results First Posted: October 11, 2013
Last Update Posted: October 11, 2013