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

NCT00974051 | Completed Results

• 1 other identifier: 07-0392
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Type 1 Diabetes

Keywords

Children; Exercise; Hypoglycemia

Outcome Measures

Primary Outcomes (1)

• Blood Glucose Nadir

  BG nadir overnight after intervention

  overnight hours

Secondary Outcomes (3)

• 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

  10:00pm to 6:00am

Study Arms (3)

Control

ACTIVE COMPARATOR

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

Other: Control

Terbutaline

EXPERIMENTAL

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

Drug: Terbutaline

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.

Other: 20% basal insulin reduction

Interventions

Terbutaline DRUG

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

Also known as: β2-adrenergic agonist

Terbutaline

20% basal insulin reduction OTHER

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

Also known as: 80% basal insulin

20% Basal Insulin Reduction

Control OTHER

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

Also known as: No intervention

Control

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Barbara Davis Center

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• 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.

  PMID: 20650471 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Motor Activity; Hypoglycemia

Interventions

Terbutaline

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Results Point of Contact

• Title: Dr. H Peter Chase
• Organization: UColorado

peter.chase@ucdenver.edu

303-724-2323

Study Officials

• Rosanna Fiallo-Scharer, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2009
• First Posted: September 10, 2009
• Study Start: March 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: October 11, 2013
• Results First Posted: October 11, 2013

Record last verified: 2013-08

Locations

US (1)