Pilot Study of the GlucoWatch G2 Biographer for the Management of Type 1 Diabetes in Children

Study Overview
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Brief Summary
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Devices such as the GlucoWatch G2 Biographer (GW2B), which constantly measure blood sugar levels, may improve the treatment of Type 1 diabetes mellitus in children. This study evaluated the GW2B when used by children in their homes.

Detailed Description
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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.

Official Title
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DirecNet Pilot Study to Evaluate the GlucoWatch G2 Biographer in the Management of Type 1 Diabetes in Children

Conditions
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Diabetes Mellitus, Insulin-Dependent

Intervention / Treatment
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* Device: GlucoWatch® G2™ Biographer (GW2B)
* Device: Continuous Glucose Monitoring System™ (CGMS)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: GlucoWatch® G2™ Biographer (GW2B)|nan|
|Device: Continuous Glucose Monitoring System™ (CGMS)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of using the GlucoWatch G2 Biographer |  |  | 
| Feasibility of collecting data from home computers |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Insulin-Dependent, Type 1 Diabetes, Continuous Glucose Monitoring Devices, Electronic Data Collection