Status:
COMPLETED
The Effect of Insulin During Exercise on the Development of Low Blood Sugar in Individuals With Type I Diabetes
Lead Sponsor:
Jaeb Center for Health Research
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Diabetes Mellitus, Type I
Eligibility:
All Genders
8-17 years
Brief Summary
Most children with type 1 diabetes have a drop in the blood sugar during exercise. This drop in the blood sugar can result in hypoglycemia (low blood sugar). In children using an insulin pump, there i...
Detailed Description
Each child will have two study visits. The visits will be between 1 and 4 weeks apart. The child will come to the research unit at the hospital at about 11:30 a.m. and will have lunch in the clinic. ...
Eligibility Criteria
Inclusion
- Clinical diagnosis of type 1 diabetes for at least 18 months (The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.)
- HbA1c \<10.0% (The DCA2000 will be used to assess eligibility.)
- Age 8.0 to \<18.0 years
- Weight \>39.5 kg at reinfusion centers and \>46.0 kg at discard centers
- BMI \>5th and \<95th percentiles for age and gender
- Stable insulin regimen for at least 1 month and not anticipating a change prior to the subject's completion of the study (Stable is defined as no change in the overall insulin program, i.e., no change from SC injections to pump.)
- Insulin regimen involves use of an insulin pump
- Normal thyroid function (measured within the previous year)
Exclusion
- A recent injury to body or limb, Addison's disease, muscular disorder, use of any medication or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol
- Asthma which has been medically treated within the last year
- Current use of glucocorticoid medication (by any route of administration)
- Current use of a beta blocker medication
- Use of pseudoephedrine 48 hours prior to visit (if used in the 48 hours prior to the scheduled visit, the visit will be deferred)
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 2 weeks prior to a visit (if a severe episode occurs within 2 weeks prior to the scheduled visit, the visit will be deferred)
- Active infection (if at the time of the scheduled visit an 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)
Key Trial Info
Start Date :
May 1 2005
Trial Type :
OBSERVATIONAL
End Date :
December 1 2005
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00147342
Start Date
May 1 2005
End Date
December 1 2005
Last Update
September 5 2016
Active Locations (6)
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1
Division of Pediatric Endocrinology and Diabetes, Stanford University
Stanford, California, United States, 94305-5208
2
Barbara Davis Center for Childhood Diabetes, University of Colorado
Aurora, Colorado, United States, 80010
3
Department of Pediatrics, Yale University School of Medicine
New Haven, Connecticut, United States, 06519
4
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207