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CompletedNCT00974051Updated Oct 11, 2013Results posted

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

An interventional study of Terbutaline and 20% basal insulin reduction in Type 1 Diabetes, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2013-10-11.

Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
10 Years to 17 Years
Sex
All
01

Study summary

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).

Read the detailed description

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.

02

Conditions studied

  • Type 1 Diabetes

Keywords

  • Children
  • Exercise
  • Hypoglycemia
03

In context

Diabetes Mellitus, Type 1

3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.

This study's enrollment of 16 is below the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,538 studies on the registry; 319 are open to participants now.

Of its 146 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.

Browse University of Colorado, Denver studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Clinical diagnosis of Type 1 Diabetes and using daily insulin therapy for at least one year.
  • Age 10 to 17 years, inclusive.
  • HbA1c \< 10.0%.
  • BMI 5-95th % for age and gender.
  • Stable Continuous Subcutaneous Insulin Infusion regimen for at least 1 month and not anticipating a change prior to the subject's completion of the study.
  • Subject uses a downloadable insulin pump.
  • Normal thyroid function (measured within the previous year).
  • For females, subject not intending to become pregnant during the study.
  • No expectation that subject will be moving out of the area for the duration of the study.
  • Informed consent form signed and understood by the parent/guardian and Child Assent form signed/understood by subjects.

Exclusion criteria

Exclusion Criteria:

  • The presence of a significant medical disorder (including epilepsy, or any cause of seizures other than hypoglycemia) that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol.
  • A recent injury to body or limb, Addison's disease, muscular disorder or disease in the judgment of the investigator that will affect the completion of the exercise protocol.
  • Asthma which has been medically treated within the last year.
  • Medically diagnosed cardiac disease, hypertension, or autonomic dysfunction.
  • Use of pseudoephedrine 48 hours prior to the visit (if used in the 48 hours prior to the scheduled visit, the visit will be deferred)
  • Severe hypoglycemia resulting in seizure of loss of consciousness in the 3 months prior to a visit.
  • Active infection (if at the time of the scheduled visit and infection is present, the visit will be deferred).
  • Anticipating a significant change in exercise regimen between visits (i.e. starting or stopping an organized sport).
  • Treatment with systemic or inhaled corticosteroids in the last 6 months.
  • Current treatment with B-blockers or presenting with high blood pressure.
  • Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver.
  • Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
  • Known allergy to Terbutaline
  • Treatment with atenolol (Tenormin), carteolol (Cartrol), labetalol (Normodyne, Trandate), metoprolol (Lopressor), nadolol (Corgard), phenelzine (Nardil), propranolol (Inderal), sotalol (Betapace), theophylline (Theo-Dur), timolol (Blocadren), tranylcypromine (Parnate), other medications for asthma, heart disease or depression.
  • Treatment with ephedrine, phenylephrine, phenylpropanolamine, or pseudoephedrine.
  • The presence of an irregular heart beat, increased heart rate glaucoma or an overactive thyroid gland.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Active comparator
    Control

    Subjects complete the same exercise routine, however no treatment is given at 9:00pm.

    Other: Control

  • Experimental
    Terbutaline

    Subjects complete same exercise routine. At 9:00pm, an oral dose of 2.5 mg of Terbutaline is administered.

    Drug: Terbutaline

  • Experimental
    20% Basal Insulin 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

Interventions

  • DrugTerbutaline

    Oral (2.5mg) one time administration at 9:00pm

    Also known as: β2-adrenergic agonist

  • Other20% basal insulin reduction

    Basal insulin rate is reduced by 20% the normal (home dose) for six hours.

    Also known as: 80% basal insulin

  • OtherControl

    No treatment is given for the study. This arm is for comparison with the two intervention arms.

    Also known as: No intervention

06

What researchers measure

Primary outcomes

  1. Blood Glucose Nadir

    BG nadir overnight after intervention

    Time frame: overnight hours

Secondary outcomes

  1. Percent of Nighttime Glucose Levels <80

    Time frame: 9:00pm to 6:00am

  2. Percent of Nighttime Glucose Levels <70

    Time frame: 10:00pm to 6:00am

  3. Percent of Nighttime Glucose Levels >250 mg/dl

    Time frame: 10:00pm to 6:00am

07

Results

Posted Oct 11, 2013

Participant flow

Recruited from the Barbara Davis Center pediatric population

Participant flow — Overall Study
MilestoneControl First, Then Terbutaline, Then 20% Basal ReductionTerbutaline First, Then 20% Basal Reduction, Then Control20% Basal Reduction First, Then Control, Then Terbutaline
Started646
Completed646
Not completed000

Outcome measures

SecondaryPercent of Nighttime Glucose Levels <80
Time frame:
9:00pm to 6:00am
Reported as:
Number · percentage of overnight glucose levels
Percent of Nighttime Glucose Levels <80
percentage of overnight glucose levelsControl ArmTerbutaline Arm20% Basal Reduction Arm
Percent of Nighttime Glucose Levels <806.604.9
SecondaryPercent of Nighttime Glucose Levels <70
Time frame:
10:00pm to 6:00am
Reported as:
Number · percentage of nighttime glucose values
Percent of Nighttime Glucose Levels <70
percentage of nighttime glucose valuesControl ArmTerbutaline Arm20% Basal Reduction Arm
Percent of Nighttime Glucose Levels <701.700.3
SecondaryPercent of Nighttime Glucose Levels >250 mg/dl
Time frame:
10:00pm to 6:00am
Reported as:
Number · percentage of overnght glucose values
Percent of Nighttime Glucose Levels >250 mg/dl
percentage of overnght glucose valuesControl ArmTerbutaline Arm20% Basal Reduction Arm
Percent of Nighttime Glucose Levels >250 mg/dl30.263.541.7
PrimaryBlood Glucose Nadir

BG nadir overnight after intervention

Time frame:
overnight hours
Reported as:
Mean · mg/dl
Blood Glucose Nadir
mg/dlControl ArmTerbutaline Arm20% Basal Reduction Arm
Blood Glucose Nadir128 ± 58189 ± 60162 ± 65

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
All Study Subjects—0/16 (0%)0/16 (0%)
Control Arm—0/16 (0%)0/16 (0%)
Terbutaline Arm—0/16 (0%)0/16 (0%)
20% Basal Reduction Arm—0/16 (0%)0/16 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)All Study Subjects
<=18 years16
Between 18 and 65 years0
>=65 years0
Age Continuous
Age Continuous(years)All Study Subjects
Mean13.3 ± 1.8
Sex: Female, Male
Sex: Female, Male(Participants)All Study Subjects
Female7
Male9
Region of Enrollment
Region of Enrollment(participants)All Study Subjects
United States16
08

Study locations

1 site
  • Barbara Davis Center
    Aurora, Colorado 80045, United States
09

References and documents

Publications

  • 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. PubMed 20650471 ↗
10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2008, a primary completion of Dec 2008 and a completion of Dec 2008. It does not say whether these dates are actual or estimated.

Results were first posted in Oct 2013, 4 years 10 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 9, 2009
First posted
Sep 10, 2009
Start
Mar 2008
Primary completionActual
Dec 2008
CompletionActual
Dec 2008
Results first posted
Oct 11, 2013
Last update
Oct 11, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00974051
Lead sponsor
University of Colorado, Denver
Responsible party
Sponsor
First posted
Sep 10, 2009
Start date
Mar 2008
Primary completion
Dec 2008
Completion
Dec 2008
Results posted
Oct 11, 2013
Last update
Oct 11, 2013

Study contacts

Rosanna Fiallo-Scharer, MD
principal investigator · University of Colorado, Denver

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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