Continuous Glucose Monitors for Children With Diabetes Mellitus
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Insulin-Dependent |
Device: The GlucoWatch® G2™ Biographer (GW2B) Device: The Continuous Glucose Monitoring System (CGMS™) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | DirecNet Inpatient Study to Test the Accuracy of Continuous Blood Glucose Monitoring Devices in Children With Type 1 Diabetes |
- Accuracy of the GlucoWatch G2 Biographer and CGMS
| Estimated Enrollment: | 90 |
| Study Start Date: | May 2002 |
| Estimated Study Completion Date: | November 2002 |
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 systematically evaluated in children less than 13 years of age. This study was conducted by the Diabetes Research in Children Network (DirecNet) to assess the accuracy of the CGMS and the GW2B glucose monitors in comparison with standard blood glucose measurements in an inpatient setting.
During 24-hour clinical research center stays at five clinical centers, approximately 90 children and adolescents with T1DM (1 to 17 years of age) wore two FDA-approved continuous glucose monitors, CGMS and GW2B, and had frequent serum glucose determinations during the day and night. To assess glucose monitor function during periods of rising and falling blood glucose, insulin-induced hypoglycemia and meal-induced hyperglycemia tests were also performed.
Eligibility| Ages Eligible for Study: | 1 Year to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Contacts and Locations| United States, California | |
| Division of Pediatric Endocrinology and Diabetes, Stanford University | |
| Stanford, California, United States, 94305-5208 | |
| United States, Colorado | |
| Barbara Davis Center for Childhood Diabetes, University of Colorado | |
| Denver, Colorado, United States, 80262 | |
| United States, Connecticut | |
| Department of Pediatrics, Yale University School of Medicine | |
| New Haven, Connecticut, United States, 06519 | |
| United States, Florida | |
| Nemours Children’s Clinic | |
| Jacksonville, Florida, United States, 32207 | |
| Jaeb Center for Health Research | |
| Tampa, Florida, United States, 33647 | |
| United States, Iowa | |
| Department of Pediatrics, University of Iowa Carver College of Medicine | |
| Iowa City, Iowa, United States, 52242 | |
| Study Chair: | William V. Tamborlane, MD | Yale University |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00069537 History of Changes |
| Other Study ID Numbers: | DirecNet 001, HD041890, HD041919-01, HD041908-01, HD041906-01, HD041918-01, HD041915 |
| Study First Received: | September 29, 2003 |
| Last Updated: | September 21, 2005 |
| Health Authority: | United States: Federal Government |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
Diabetes Mellitus, Insulin-Dependent Type 1 Diabetes Diabetes in Children Continuous Glucose Monitoring Devices |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013