Randomized Clinical Trial to Assess the Effectiveness of the GlucoWatch Biographer
Completed · Phase 4
Conditions studied: Diabetes Mellitus, Insulin-Dependent
In brief
This study will evaluate the safety and effectiveness of a continuous glucose monitor in children with Type 1 diabetes mellitus (T1DM).
Key facts
- Study ID
- NCT00069628
- Run by
- Jaeb Center for Health Research
- People needed
- 200
- Starts
- 2003-07-01
- Expected to finish
- 2004-11-01
- Last updated by the study team
- 2016-09-05
Who can join
Age: 7 and older, up to 17. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Clinical diagnosis of type 1 diabetes
- Insulin therapy (either a pump or at least 2 injections per day) for at least one year prior to study entry
- HbA1c between 7.0 and 11.0%
- Stable insulin regimen for the 2 months prior to study entry and no plans to switch the modality of insulin administration during the next 6 months (e.g., injection user switching to a pump, pump user switching to injections, or the addition of Lantus [Glargine] insulin)
- Agree to comply with study requirements, including the performance of at least 4 fingerstick glucose checks a day using a home glucose monitor
- Comprehend written English
- Female participants must not intend to become pregnant during the next 6 months
- Plan to remain in the area of the clinical center during the next 6 months
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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