Type 1 DiabetesNCT00974051
Use of Terbutaline or a Reduction in Basal Insulin in the Prevention of Nocturnal Hypoglycemia
A study testing Terbutaline and 20% basal insulin reduction in people with Type 1 Diabetes, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Terbutaline and 20% basal insulin reduction
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Dec 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
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.
- Conditions
- Type 1 Diabetes
- Being tested
- Terbutaline, 20% basal insulin reduction, Control
- Keywords
- Children, Exercise, Hypoglycemia
- Medical subject headings
- Diabetes Mellitus, Type 1, Motor Activity, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TerbutalineDrug
Also called β2-adrenergic agonist
Oral (2.5mg) one time administration at 9:00pm
20% basal insulin reductionOther
Also called 80% basal insulin
Basal insulin rate is reduced by 20% the normal (home dose) for six hours.
ControlOther
Also called No intervention
No treatment is given for the study. This arm is for comparison with the two intervention arms.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Subjects complete the same exercise routine, however no treatment is given at 9:00pm. Receives: Other: Control |
| Terbutaline | Experimental | Subjects complete same exercise routine. At 9:00pm, an oral dose of 2.5 mg of Terbutaline is administered. Receives: 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. Receives: Other: 20% basal insulin reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose Nadir
BG nadir overnight after intervention
Measured: overnight hours
Secondary outcomes (3)
Percent of Nighttime Glucose Levels <80
Measured: 9:00pm to 6:00am
Percent of Nighttime Glucose Levels <70
Measured: 10:00pm to 6:00am
Percent of Nighttime Glucose Levels >250 mg/dl
Measured: 10:00pm to 6:00am
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2009 (estimated)
- Study startMar 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rosanna Fiallo-Scharer, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974051
- Sponsor's protocol ID
- 07-0392
- Status last verified
- Aug 2013
- First submitted
- 9 Sep 2009
- Last updated
- 11 Oct 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00974051
- Acronym / sponsor ID
- 07-0392
- Conditions
- Type 1 Diabetes
- Keywords
- Children, Exercise, Hypoglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 10 Sep 2009 (estimated)
- Results
- Posted 11 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: ControlSubjects complete the same exercise routine, however no treatment is given at 9:00pm. |
| Terbutaline | Experimental | Drug: TerbutalineSubjects complete same exercise routine. At 9:00pm, an oral dose of 2.5 mg of Terbutaline is administered. |
| 20% Basal Insulin Reduction | Experimental | Other: 20% basal insulin reductionAll subjects complete the same exercise session. At 9:00pm, subject's basal rate is decreased by 20% for six hours. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TerbutalineAlso: β2-adrenergic agonistOral (2.5mg) one time administration at 9:00pm | Drug | Terbutaline |
| 20% basal insulin reductionAlso: 80% basal insulinBasal insulin rate is reduced by 20% the normal (home dose) for six hours. | Other | 20% Basal Insulin Reduction |
| ControlAlso: No interventionNo treatment is given for the study. This arm is for comparison with the two intervention arms. | Other | Control |
Primary outcome
Blood Glucose Nadir
Time frame: overnight hours
BG nadir overnight after intervention
3 secondary outcomes
Percent of Nighttime Glucose Levels <80
Time frame: 9:00pm to 6:00am
Percent of Nighttime Glucose Levels <70
Time frame: 10:00pm to 6:00am
Percent of Nighttime Glucose Levels >250 mg/dl
Time frame: 10:00pm to 6:00am
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20650471Taplin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosanna Fiallo-Scharer, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Terbutaline and 20% basal insulin reduction in people with Type 1 Diabetes, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Glucose Nadir (time frame: overnight hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00974051, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2013.