Continuous Glucose Monitors for Children With Diabetes Mellitus

Completed · Phase 4

Conditions studied: Diabetes Mellitus, Insulin-Dependent

In brief

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).

Key facts

Study ID

NCT00069537

Run by

Jaeb Center for Health Research

People needed

90

Starts

2002-05-01

Expected to finish

2002-11-01

Last updated by the study team

2016-09-05

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

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 — Denver, 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 Carver College of Medicine — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

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