beta
Trial Radar AI
One study matched filter criteria
Card View
Back to Search

Continuous Glucose Monitors for Children With Diabetes Mellitus Phase 4 90

Completed
Clinical Trial NCT00069537 was designed to study Treatment for Diabetes Mellitus, Insulin-Dependent. This was a Phase 4 interventional study that is now completed. The study started on 1 May 2002, with plans to enroll 90 participants. Led by Jaeb Center for Health Research, the expected completion date was 1 November 2002. The latest data from ClinicalTrials.gov was last updated on 5 September 2016.
Brief Summary
Good control of blood glucose levels is important in preventing complications from diabetes. This study assessed the accuracy and reliability of two FDA-approved continuous glucose monitors, the Continuous Glucose Monitoring System (CGMS) and the GlucoWatch G2 Biographer (GW2B), in children with type 1 diabetes mellitus (T1DM).
Detailed Description
Intensive control of blood glucose levels has been shown to substantially prevent or delay complications of T1DM in adolescents and adults. The major limitation to implementation of intensive glycemic control is hypoglycemia. Younger children may be at increased risk for hypoglycemia and the risk/benefit ratio of intensive glycemic control may be less favorable in this population. Intensive therapy has not been syste...Show More
Official Title

DirecNet Inpatient Study to Test the Accuracy of Continuous Blood Glucose Monitoring Devices in Children With Type 1 Diabetes

Conditions
Diabetes Mellitus, Insulin-Dependent
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...
Show More
Other Study IDs
  • DirecNet 001
  • HD041890
  • HD041919-01
  • HD041908-01
  • HD041906-01
  • HD041918-01
  • HD041915
NCT ID Number
NCT00069537
Start Date (Actual)
2002-05
Last Update Posted
2016-09-05
Completion Date (Estimated)
2002-11
Enrollment (Estimated)
90
Study Type
Interventional
PHASE
Phase 4
Status
Completed
Keywords
Diabetes Mellitus, Insulin-Dependent
Type 1 Diabetes
Diabetes in Children
Continuous Glucose Monitoring Devices
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
N/A
The GlucoWatch® G2™ Biographer (GW2B)
The Continuous Glucose Monitoring System (CGMS™)
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Accuracy of the GlucoWatch G2 Biographer and CGMS
Eligibility Criteria

Eligible Ages
Child
Minimum Age
1 Year
Eligible Sexes
All
  • Clinical diagnosis of type 1 diabetes mellitus for at least 1 year prior to study entry
  • For children over 2 years of age, body mass index between the 5th and 95th percentile for age and gender
  • Weight >= 12 kg (26.5 lbs) if < 7 years of age and >= 16 kg (35 lbs) if >7 years of age
  • Normal hematocrit

  • Current use of glucocorticoids
  • Skin or other medical disorders that would affect completion of the study
  • History of seizures other than those attributable to either hypoglycemia or high fever
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