Status:
COMPLETED
Pilot Study of the Navigator Continuous Glucose Monitor
Lead Sponsor:
Jaeb Center for Health Research
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Diabetes Mellitus, Insulin-Dependent
Eligibility:
All Genders
3-17 years
Phase:
PHASE2
PHASE3
Brief Summary
This study is being done to find out how accurate the Navigator continuous glucose monitor is in children. It is also being done to see if use of the Navigator can improve blood sugar control and help...
Detailed Description
Approximately 60 children will be recruited from five centers in the United States to participate in this study. The information gained from this study will be used to plan a larger study in which hal...
Eligibility Criteria
Inclusion
- 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 years to less than 18.0 years
- Subject has used a downloadable insulin pump or Lantus with MDI of a short-acting insulin (e.g. Humalog or Novolog) for at least 6 months
- Parent/guardian and subject understand the study protocol and agree to comply with it
- Subjects \>9.0 years old and primary care giver (i.e., parent or guardian) comprehend written English
- Subject has a home computer with email access
- For females, subject not intending to become pregnant during the next 3 months
- No expectation that subject will be moving out of the area of the clinical center during the next 3 months
- Informed Consent Form signed by the parent/guardian and Child Assent Form signed by the subject
Exclusion
- The presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol.
- The presence of any of the following diseases:
- Asthma if treated with systemic or inhaled corticosteroids in the last 6 months
- Cystic fibrosis
- Other major illness that in the judgment of the investigator might interfere with the completion of the protocol (Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment)
- Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian).
- 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.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
End Date :
August 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00166673
Start Date
August 1 2005
End Date
August 1 2007
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