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Clinical Trial NCT00166673 for Diabetes Mellitus, Insulin-Dependent is completed. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Pilot Study of the Navigator Continuous Glucose Monitor Phase 2, Phase 3 60 At-Home
Clinical Trial NCT00166673 was an interventional study for Diabetes Mellitus, Insulin-Dependent that is now completed. The study started on 1 August 2005, with plans to enroll 60 participants. Led by Jaeb Center for Health Research, the expected completion date was 1 August 2007. The latest data from ClinicalTrials.gov was last updated on 5 September 2016.
Brief Summary
This study is being done to find out how accurate the Navigator continuous glucose monitor is in children. It is also being done to see if use of the Navigator can improve blood sugar control and help prevent low blood sugar events. This study has three basic parts: Use of the Navigator at home for one week without being able to see the blood sugar readings; a Baseline visit or a 24-hour admission to a research unit ...Show More
Detailed Description
Approximately 60 children will be recruited from five centers in the United States to participate in this study. The information gained from this study will be used to plan a larger study in which half of the patients will use the Navigator and half will not. Children who participate in this study will not be eligible to take part in the larger study.
The Navigator provides a glucose reading every 60 seconds (or 144...
Show MoreOfficial Title
A Pilot Study to Evaluate the Navigator Continuous Glucose Sensor in the Management of Type 1 Diabetes in Children
Conditions
Diabetes Mellitus, Insulin-DependentPublications
Scientific articles and research papers published about this clinical trial:- Buckingham B, Ruedy K, Kollman C, Beck R, Tamborlane W, Mauras N, Weinzimer S, Chase P, Tsalikian E; and the Diabetes Research in Children Network (DirecNet) Study Group. Family Assessment of the Utility of the DirecNet Applied Treatment Algorithm (DATA) for Insulin Adjustments in Real-Time and Retrospective Analyses of Continuous Glucose Monitoring (CGM) Diabetes 2006; 55(Suppl....
Other Study IDs
- DirecNet 006
- HD041890
- HD041919
- HD041908
- HD041906
- HD041918
- HD041915
NCT ID Number
Start Date (Actual)
2005-08
Last Update Posted
2016-09-05
Completion Date (Estimated)
2007-08
Enrollment (Estimated)
60
Study Type
Interventional
PHASE
Phase 2
Phase 3
Phase 3
Status
Completed
Keywords
Diabetes Mellitus, Insulin-Dependent
Type 1 Diabetes
Continuous Glucose Monitoring Devices
Electronic Data Collection
Type 1 Diabetes
Continuous Glucose Monitoring Devices
Electronic Data Collection
Design Allocation
Non-Randomized
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
N/A | FreeStyle Navigator Continuous Glucose Monitoring System |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Feasibility of using the Navigator sensor on a daily basis (Average number of sensors used per week, Average number of hours of use per sensor, Number of sensors per week that fail to calibrate) | ||
Navigator Accuracy |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Psychosocial Questionnaires | ||
Exploratory assessment of impact of Navigator on HbA1c |
Eligibility Criteria
Eligible Ages
Child
Minimum Age
3 Years
Eligible Sexes
All
- Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
- Age 3.0 years to less than 18.0 years
- Subject has used a downloadable insulin pump or Lantus with MDI of a short-acting insulin (e.g. Humalog or Novolog) for at least 6 months
- Parent/guardian and subject understand the study protocol and agree to comply with it
- Subjects >9.0 years old and primary care giver (i.e., parent or guardian) comprehend written English
- Subject has a home computer with email access
- For females, subject not intending to become pregnant during the next 3 months
- No expectation that subject will be moving out of the area of the clinical center during the next 3 months
- Informed Consent Form signed by the parent/guardian and Child Assent Form signed by the subject
The presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol.
The presence of any of the following diseases:
- Asthma if treated with systemic or inhaled corticosteroids in the last 6 months
- Cystic fibrosis
- Other major illness that in the judgment of the investigator might interfere with the completion of the protocol (Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment)
Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian).
Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
Jaeb Center for Health ResearchNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)No contact data.
6 Study Locations in 1 Countries
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, Aurora, Colorado, 80010, 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