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De klinische studie NCT00069537 voor Diabetes Mellitus, Insulin-Dependent is afgerond. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
Eén studie komt overeen met de filtercriteria
Kaartweergave
Continuous Glucose Monitors for Children With Diabetes Mellitus Fase 4 90
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De klinische studie NCT00069537 onderzocht behandeling bij Diabetes Mellitus, Insulin-Dependent. Deze Fase 4 interventioneel studie is nu afgerond. Er werd gestreefd naar inclusie van 90 deelnemers vanaf 1 mei 2002. De studie werd geleid door Jaeb Center for Health Research en was gepland te worden voltooid op 1 november 2002. Laatste update op ClinicalTrials.gov: 5 september 2016.
Beknopte samenvatting
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).
Uitgebreide beschrijving
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...Toon meer
Officiële titel
DirecNet Inpatient Study to Test the Accuracy of Continuous Blood Glucose Monitoring Devices in Children With Type 1 Diabetes
Aandoeningen
Diabetes Mellitus, Insulin-DependentPublicaties
Wetenschappelijke artikelen en onderzoekspapers gepubliceerd over deze klinische studie:- 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...
Andere studie-ID's
- DirecNet 001
- HD041890
- HD041919-01
- HD041908-01
- HD041906-01
- HD041918-01
- HD041915
NCT-ID
Startdatum (Werkelijk)
2002-05
Laatste update geplaatst
2016-09-05
Verwachte einddatum
2002-11
Inschrijving (Geschat)
90
Studietype
Interventioneel
FASE
Fase 4
Status
Afgerond
Trefwoorden
Diabetes Mellitus, Insulin-Dependent
Type 1 Diabetes
Diabetes in Children
Continuous Glucose Monitoring Devices
Type 1 Diabetes
Diabetes in Children
Continuous Glucose Monitoring Devices
Primaire doel
Behandeling
Toewijzing
Niet-gerandomiseerd
Interventiemodel
Enkele groep
Blindering
Geen (Open-label)
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
N.v.t. | The GlucoWatch® G2™ Biographer (GW2B) The Continuous Glucose Monitoring System (CGMS™) |
Primaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Accuracy of the GlucoWatch G2 Biographer and CGMS |
Geschiktheidscriteria
Leeftijd van deelnemers
Kind
Minimumleeftijd
1 Year
Geslachten die in aanmerking komen voor de studie
Allen
- 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 ResearchNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Geen contactgegevens beschikbaar
6 Studielocaties in 1 landen
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