At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 146 enrolled
Drug / intervention
Continuous glucose monitor +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Clinical Trial to Assess the Efficacy and Safety of Real-Time Continuous Glucose Monitoring in the Management of Type 1 Diabetes in Young Children (4 to <10 Year Olds)
In Brief
A Phase 3 clinical trial evaluating Continuous glucose monitor and Home blood glucose monitor for Diabetes Mellitus, Type 1. Completed, enrolled 146 participants across 5 sites.
Detailed Summary
The purpose of this study is to determine the efficacy, tolerability, safety, and effect on quality of life of CGM in children 4 to less than 10 years of age with type 1 diabetes.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 1
CountriesUnited States
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2008
Enrollment StartSep 2010
Primary CompletionJun 2011
Study CompletionJan 2012
TodayJul 2026
First PostedSep 26, 2008
Enrollment StartSep 1, 2010
Primary CompletionJun 1, 2011
Study CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 17.8 years ago
Interventions
Continuous glucose monitordevice
Daily use of a continuous glucose monitor
Home blood glucose monitordevice
Home monitoring 3 or more times a day