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Assessing Continuous Glucose Monitors in Healthy Children Phase 4 20

Completed
Clinical Trial NCT00069602 was designed to study Treatment for Diabetes Mellitus. This was a Phase 4 interventional study that is now completed. The study started on August 1, 2002, with plans to enroll 20 participants. Led by Jaeb Center for Health Research, the expected completion date was November 1, 2002. The latest data from ClinicalTrials.gov was last updated on September 5, 2016.
Brief Summary
Continuous glucose monitors may be useful in the treatment of children with Type 1 diabetes mellitus. The purpose of this study was to determine whether two FDA-approved continuous glucose monitors, the Continuous Glucose Monitoring System (CGMS) and the GlucoWatch G2TM Biographer (GW2B), are sufficiently accurate to use in future studies to characterize glucose levels in children.
Detailed Description
The characterization of glucose levels in healthy children during day and nighttime is critical to the interpretation of glucose levels in diseases such as diabetes. This study was conducted by the DirecNet Study Group to determine whether two FDA-approved continuous glucose monitors are sufficiently accurate.

The study was conducted at five clinical centers and enrolled approximately 20 healthy children (ages 7 to ...

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Official Title

DirecNet Pilot Study to Assess the Accuracy of Continuous Glucose Monitors in Normal Children

Conditions
Diabetes Mellitus
Publications
Scientific articles and research papers published about this clinical trial:
  • Mauras N, Beck R, Ruedy K, Booth A, Weinzimer S, and the Diabetes Research in Children Network (DirecNet) Study Group. The Physiological Variations of Plasma Glucose Concentrations in Healthy, Non-Diabetic Children: Use of Continuous Glucose Sensors. Pediatr Res 2003 Apr;53(4Pt 2):1A-669A
  • Weinzimer S, Beck R, Ruedy K, Booth A, Boland E, and t...
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Other Study IDs
  • DirecNet 002
  • HD041890
  • HD041919-01
  • HD041908-01
  • HD041906-01
  • HD041918-01
  • HD041915
NCT ID Number
NCT00069602
Start Date (Actual)
2002-08
Last Update Posted
2016-09-05
Completion Date (Estimated)
2002-11
Enrollment (Estimated)
20
Study Type
Interventional
PHASE
Phase 4
Status
Completed
Keywords
Continuous Glucose Monitoring Devices
Blood glucose profiles in normal children
Blood glucose profiles in non-diabetic children
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
N/A
Continuous Glucose Monitoring System (CGMS)
GlucoWatch G2TM Biographer (GW2B)
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Accuracy of the GlucoWatch G2 Biographer and CGMS sensors
Eligibility Criteria

Eligible Ages
Child
Minimum Age
7 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • Weight >= 16.0 kg (35 lbs)
  • Body mass index between the 10th to 90th percentile for age and sex
  • HbA1c within normal limits
  • Hematocrit within normal limits

  • History of diabetes
  • History of positive islet cell antibody testing
  • Family history of Type 1 or Type 2 diabetes in a sibling or parent
  • Medication use of any type in the 7 days prior to study entry
  • Skin abnormalities contraindicating device use
Jaeb Center for Health Research logoJaeb Center for Health Research
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) logoNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
No contact data.
6 Study Locations in 1 Countries

California

Division of Pediatric Endocrinology and Diabetes, Stanford University, Stanford, California, 94305-5208, United States

Colorado

Barbara Davis Center for Childhood Diabetes, University of Colorado, Denver, Colorado, 80262, United States

Connecticut

Department of Pediatrics, Yale University School of Medicine, New Haven, Connecticut, 06519, United States

Florida

Nemours Children's Clinic, Jacksonville, Florida, 32207, United States
Jaeb Center for Health Research, Tampa, Florida, 33647, United States

Iowa

Department of Pediatrics, University of Iowa Carver College of Medicine, Iowa City, Iowa, 52242, United States