Hormone Responses During Hypoglycemia and the Accuracy of Continuous Glucose Monitors
Completed
Conditions studied: Type 1 Diabetes
In brief
The primary objective of this study will be to compare the glucose level at which counter-regulatory hormone responses occur during hypoglycemia in young children with diabetes, with the glucose level counter regulatory hormone responses that occur in older children with diabetes.
Key facts
- Study ID
- NCT00607139
- Run by
- Jaeb Center for Health Research
- People needed
- 28
- Starts
- 2006-12-01
- Expected to finish
- 2007-04-01
- Last updated by the study team
- 2016-09-05
Who can join
Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
- Age 3.0 to <7.0 years or 12.0 to <18.0 years
- Weight >12.8 kg (28.2 lbs) for reinfusion centers (centers that employ reinfusion of blood drawn to clear the dead space in intravenous catheters) and >17.4 kg (38.3 lbs) for discard centers (centers that discard the blood drawn to clear the dead space)
- Hemoglobin A1c <10.0%
- Subject currently uses an insulin pump
- Parent/guardian and subject understand the study protocol and agree to comply with it
- Informed Consent Form signed by the parent/guardian and Child Assent Form signed by the subject
You may not qualify if…
- The presence of a significant medical disorder or use of any medication that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol.
- Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
- A severe hypoglycemic event resulting in seizure or loss of consciousness in the last month
- Use of systemic or inhaled corticosteroids in the last month
- Cystic fibrosis
Where it is running
- Division of Pediatric Endocrinology and Diabetes, Stanford University — Stanford, California, United States
- Barbara Davis Center for Childhood Diabetes, University of Colorado — Aurora, Colorado, United States
- Department of Pediatrics, Yale University School of Medicine — New Haven, Connecticut, United States
- Nemours Children's Clinic — Jacksonville, Florida, United States
- Jaeb Center for Health Research — Tampa, Florida, United States
- Department of Pediatrics, University of Iowa — Iowa City, Iowa, United States
Full record on ClinicalTrials.gov
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