Pilot Study of the GlucoWatch G2 Biographer for the Management of Type 1 Diabetes in Children
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Insulin-Dependent |
Device: GlucoWatch® G2™ Biographer (GW2B) Device: Continuous Glucose Monitoring System™ (CGMS) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Educational/Counseling/Training |
| Official Title: | DirecNet Pilot Study to Evaluate the GlucoWatch G2 Biographer in the Management of Type 1 Diabetes in Children |
- Feasibility of using the GlucoWatch G2 Biographer
- Feasibility of collecting data from home computers
| Estimated Enrollment: | 15 |
| Study Start Date: | February 2003 |
| Estimated Study Completion Date: | June 2003 |
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.
Eligibility| Ages Eligible for Study: | 7 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| United States, California | |
| Division of Pediatric Endocrinology and Diabetes, Stanford University | |
| Stanford, California, United States, 94305-5208 | |
| United States, Colorado | |
| Barbara Davis Center for Childhood Diabetes, University of Colorado | |
| Denver, Colorado, United States, 80262 | |
| United States, Connecticut | |
| Department of Pediatrics, Yale University School of Medicine | |
| New Haven, Connecticut, United States, 06519 | |
| United States, Florida | |
| Nemours Children’s Clinic | |
| Jacksonville, Florida, United States, 32207 | |
| Jaeb Center for Health Research | |
| Tampa, Florida, United States, 33647 | |
| United States, Iowa | |
| Department of Pediatrics, University of Iowa Carver College of Medicine | |
| Iowa City, Iowa, United States, 52242 | |
| Study Chair: | William V Tamborlane, MD | Yale University |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00069615 History of Changes |
| Other Study ID Numbers: | DirecNet 003, HD041890, HD041919-01, HD041908-01, HD041906-01, HD041918-01, HD041915 |
| Study First Received: | September 29, 2003 |
| Last Updated: | September 21, 2005 |
| Health Authority: | United States: Federal Government |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
Diabetes Mellitus, Insulin-Dependent Type 1 Diabetes Continuous Glucose Monitoring Devices Electronic Data Collection |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013