Type 1 Diabetes
Conditions
Keywords
Children, Exercise, Hypoglycemia
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).
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.
Interventions
DRUGTerbutaline
Oral (2.5mg) one time administration at 9:00pm
OTHER20% basal insulin reduction
Basal insulin rate is reduced by 20% the normal (home dose) for six hours.
OTHERControl
No treatment is given for the study. This arm is for comparison with the two intervention arms.
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Glucose Nadir | overnight hours | BG nadir overnight after intervention |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Participant flow
Recruitment details
Recruited from the Barbara Davis Center pediatric population
Pre-assignment details
no notes
Participants by arm
| Arm | Count |
|---|---|
| All Study Subjects 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. | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | All Study Subjects |
|---|---|
| Age, Categorical <=18 years | 16 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age Continuous | 13.3 years STANDARD_DEVIATION 1.8 |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 |
Outcome results
Primary
Blood Glucose Nadir
BG nadir overnight after intervention
Time frame: overnight hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arm | Blood Glucose Nadir | 128 mg/dl | Standard Deviation 58 |
| Terbutaline Arm | Blood Glucose Nadir | 189 mg/dl | Standard Deviation 60 |
| 20% Basal Reduction Arm | Blood Glucose Nadir | 162 mg/dl | Standard Deviation 65 |
Secondary
Percent of Nighttime Glucose Levels >250 mg/dl
Time frame: 10:00pm to 6:00am
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Arm | Percent of Nighttime Glucose Levels >250 mg/dl | 30.2 percentage of overnght glucose values |
| Terbutaline Arm | Percent of Nighttime Glucose Levels >250 mg/dl | 63.5 percentage of overnght glucose values |
| 20% Basal Reduction Arm | Percent of Nighttime Glucose Levels >250 mg/dl | 41.7 percentage of overnght glucose values |
Secondary
Percent of Nighttime Glucose Levels <70
Time frame: 10:00pm to 6:00am
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Arm | Percent of Nighttime Glucose Levels <70 | 1.7 percentage of nighttime glucose values |
| Terbutaline Arm | Percent of Nighttime Glucose Levels <70 | 0 percentage of nighttime glucose values |
| 20% Basal Reduction Arm | Percent of Nighttime Glucose Levels <70 | 0.3 percentage of nighttime glucose values |
Secondary
Percent of Nighttime Glucose Levels <80
Time frame: 9:00pm to 6:00am
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Arm | Percent of Nighttime Glucose Levels <80 | 6.6 percentage of overnight glucose levels |
| Terbutaline Arm | Percent of Nighttime Glucose Levels <80 | 0 percentage of overnight glucose levels |
| 20% Basal Reduction Arm | Percent of Nighttime Glucose Levels <80 | 4.9 percentage of overnight glucose levels |