- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00069615
Pilot Study of the GlucoWatch G2 Biographer for the Management of Type 1 Diabetes in Children
DirecNet Pilot Study to Evaluate the GlucoWatch G2 Biographer in the Management of Type 1 Diabetes in Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The proper role of the GW2B in the management of Type 1 diabetes in children has not been determined. As a prelude to a large-scale randomized clinical trial (RCT) to compare the effect on glycemic control, hypoglycemia, and quality of life of using a GW2B versus standard care, the DirecNet Study Group conducted a pilot study to assess the feasibility of the protocol planned for the RCT and to collect data on changes in HbA1c, frequency of hypoglycemia, frequency of skin reactions, and quality of life after using the GW2B for three months.
Fifteen children and adolescents with Type 1 diabetes participated in this study. Each patient was provided with a personal computer for weekly downloading of the GW2B and for completion of questionnaires regarding hypoglycemia and GW2B use. Participants received study telephone calls after 1, 2, and 4 weeks and every 4 weeks thereafter to review their diabetes management. Participants had a follow-up visit at Week 29. The Continuous Glucose Monitoring System was inserted at this visit to assess hypoglycemia over three days. A follow-up visit was performed at Week 30 to measure HbA1c and administer psychosocial questionnaires.
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
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California
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Stanford, California, United States, 94305-5208
- Division of Pediatric Endocrinology and Diabetes, Stanford University
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Colorado
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Denver, Colorado, United States, 80262
- Barbara Davis Center for Childhood Diabetes, University of Colorado
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Connecticut
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New Haven, Connecticut, United States, 06519
- Department of Pediatrics, Yale University School of Medicine
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Florida
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Jacksonville,, Florida, United States, 32207
- Nemours Children's Clinic
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Tampa, Florida, United States, 33647
- Jaeb Center for Health Research
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Iowa
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Iowa City, Iowa, United States, 52242
- Department of Pediatrics, University of Iowa Carver College of Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- Diagnosis of Type 1 diabetes
- Duration of diabetes > 1 year
- Daily insulin therapy (pump or at least 2 injections/day)
- Stable insulin regimen; not expected to change administration modality within the next 3 months (e.g., injection user switching to pump)
Exclusion Criteria
- The presence of skin abnormalities or 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.
- Prior use of a GWB prescribed for home use (Prior use of a GWB as part of a research study is allowable)
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
- 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.
Study Plan
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Feasibility of using the GlucoWatch G2 Biographer
|
Feasibility of collecting data from home computers
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Stuart Weinzimer, Katrina Ruedy, Jennifer Fisher, Linda Larson, Jennifer Block, Elizabeth Boland, Keisha Bird, and the Diabetes Research in Children Network (DirecNet) Study Group: Diabetes Research in Children Network (DirecNet) Outpatient Pilot Study to Evaluate the GlucoWatch G2 Biographer (GW2B) in the Management of Type 1 Diabetes (T1DM) in Children. Diabetes Technol Ther 2004; 6(2):280.
- Stuart Weinzimer, Katrina Ruedy, Linda Larson, Jennifer Block, Jennifer Fisher, Elizabeth Doyle, Keisha Bird, and the Diabetes Research in Children Network (DirecNet) Study Group: Diabetes Research in Children Network (DirecNet) Outpatient Pilot Study to Evaluate the Feasibility of Computer-Based Data Acquisition and Transmission. Pediatr Res 2004; 55 (4 Pt 2):138A.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DirecNet 003
- HD041890
- HD041919-01
- HD041908-01
- HD041906-01
- HD041918-01
- HD041915
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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