Trial Outcomes & Findings for Use of Terbutaline or a Reduction in Basal Insulin in the Prevention of Nocturnal Hypoglycemia (NCT NCT00974051)
NCT ID: NCT00974051
Last Updated: 2013-10-11
Results Overview
BG nadir overnight after intervention
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
overnight hours
Results posted on
2013-10-11
Participant Flow
Recruited from the Barbara Davis Center pediatric population
no notes
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
4
|
6
|
|
Overall Study
COMPLETED
|
6
|
4
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Terbutaline or a Reduction in Basal Insulin in the Prevention of Nocturnal Hypoglycemia
Baseline characteristics by cohort
| Measure |
All Study Subjects
n=16 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
16 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
13.3 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: overnight hoursBG nadir overnight after intervention
Outcome measures
| Measure |
Control Arm
n=16 Participants
No treatment is given during the Control night. Glucose levels from 9 pm to 6 am are analyzed.
|
Terbutaline Arm
n=16 Participants
2.5 mg oral terbutaline is given at 9pm during the Terbutaline night. Glucose levels from 9 pm to 6 am are analyzed.
|
20% Basal Reduction Arm
n=16 Participants
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.
|
|---|---|---|---|
|
Blood Glucose Nadir
|
128 mg/dl
Standard Deviation 58
|
189 mg/dl
Standard Deviation 60
|
162 mg/dl
Standard Deviation 65
|
SECONDARY outcome
Timeframe: 9:00pm to 6:00amOutcome measures
| Measure |
Control Arm
n=16 Participants
No treatment is given during the Control night. Glucose levels from 9 pm to 6 am are analyzed.
|
Terbutaline Arm
n=16 Participants
2.5 mg oral terbutaline is given at 9pm during the Terbutaline night. Glucose levels from 9 pm to 6 am are analyzed.
|
20% Basal Reduction Arm
n=16 Participants
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.
|
|---|---|---|---|
|
Percent of Nighttime Glucose Levels <80
|
6.6 percentage of overnight glucose levels
|
0 percentage of overnight glucose levels
|
4.9 percentage of overnight glucose levels
|
SECONDARY outcome
Timeframe: 10:00pm to 6:00amOutcome measures
| Measure |
Control Arm
n=16 Participants
No treatment is given during the Control night. Glucose levels from 9 pm to 6 am are analyzed.
|
Terbutaline Arm
n=16 Participants
2.5 mg oral terbutaline is given at 9pm during the Terbutaline night. Glucose levels from 9 pm to 6 am are analyzed.
|
20% Basal Reduction Arm
n=16 Participants
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.
|
|---|---|---|---|
|
Percent of Nighttime Glucose Levels <70
|
1.7 percentage of nighttime glucose values
|
0 percentage of nighttime glucose values
|
0.3 percentage of nighttime glucose values
|
SECONDARY outcome
Timeframe: 10:00pm to 6:00amOutcome measures
| Measure |
Control Arm
n=16 Participants
No treatment is given during the Control night. Glucose levels from 9 pm to 6 am are analyzed.
|
Terbutaline Arm
n=16 Participants
2.5 mg oral terbutaline is given at 9pm during the Terbutaline night. Glucose levels from 9 pm to 6 am are analyzed.
|
20% Basal Reduction Arm
n=16 Participants
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.
|
|---|---|---|---|
|
Percent of Nighttime Glucose Levels >250 mg/dl
|
30.2 percentage of overnght glucose values
|
63.5 percentage of overnght glucose values
|
41.7 percentage of overnght glucose values
|
Adverse Events
All Study Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Terbutaline Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
20% Basal Reduction Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place