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

August 2, 2013 updated by: University of Colorado, Denver

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Barbara Davis Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Subjects complete the same exercise routine, however no treatment is given at 9:00pm.
Other: Control
No treatment is given for the study. This arm is for comparison with the two intervention arms.
Other Names:
  • No intervention
Experimental: Terbutaline
Subjects complete same exercise routine. At 9:00pm, an oral dose of 2.5 mg of Terbutaline is administered.
Drug: Terbutaline
Oral (2.5mg) one time administration at 9:00pm
Other Names:
  • β2-adrenergic agonist
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
Basal insulin rate is reduced by 20% the normal (home dose) for six hours.
Other Names:
  • 80% basal insulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Glucose Nadir
Time Frame: overnight hours
BG nadir overnight after intervention
overnight hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent of Nighttime Glucose Levels <80
Time Frame: 9:00pm to 6:00am
9:00pm to 6:00am
Percent of Nighttime Glucose Levels <70
Time Frame: 10:00pm to 6:00am
10:00pm to 6:00am
Percent of Nighttime Glucose Levels >250 mg/dl
Time Frame: 10:00pm to 6:00am
10:00pm to 6:00am

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: Rosanna Fiallo-Scharer, MD, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

September 9, 2009

First Submitted That Met QC Criteria

September 9, 2009

First Posted (Estimate)

September 10, 2009

Study Record Updates

Last Update Posted (Estimate)

October 11, 2013

Last Update Submitted That Met QC Criteria

August 2, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-0392

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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