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The GlucoWatch G2 Biographer for the Management of Type 1 Diabetes in Children Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about The GlucoWatch G2 Biographer for the Management of Type 1 Diabetes in Children conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. The GlucoWatch G2 Biographer for the Management of Type 1 Diabetes in Children Clinical research trials and The GlucoWatch G2 Biographer for the Management of Type 1 Diabetes in Children health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as The GlucoWatch G2 Biographer for the Management of Type 1 Diabetes in Children. The GlucoWatch G2 Biographer for the Management of Type 1 Diabetes in Children Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a The GlucoWatch G2 Biographer for the Management of Type 1 Diabetes in Children clinical trial. Human subjects frequently get the finest healthcare available for their The GlucoWatch G2 Biographer for the Management of Type 1 Diabetes in Children condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > The GlucoWatch G2 Biographer for the Management of Type 1 Diabetes in Children  The GlucoWatch G2 Biographer for the Management of Type 1 Diabetes in Children
The GlucoWatch G2 Biographer for the Management of Type 1 Diabetes in Children
For Condition: Diabetes Mellitus, Insulin-Dependent
Status: Completed
Sponsor(s): National Institute of Child Health and Human Development (NICHD) , National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Synopsis: 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 GWB when used by children in their homes.
Details: 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:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: 7 Years/17 Years
Genders: Both
Protocol Entry Criteria: 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)
Total Enrollment: 15
Location and Contact Information:
Overall Study Official:
WilliamTamborlane, Study Chair, Yale University
Department of Pediatrics, University of Iowa Carver College of Medicine
Iowa City, Iowa, 52242
United States
Department of Pediatrics, Yale University School of Medicine
New Haven, Connecticut, 06519
United States
Barbara Davis Center for Childhood Diabetes, University of Colorado
Denver, Colorado, 80262
United States
Division of Pediatric Endocrinology and Diabetes, Stanford University
Stanford, California, 94305-5208
United States
Nemours Children’s Clinic
Jacksonville, Florida, 32207
United States
Jaeb Center for Health Research
Tampa, Florida, 33647
United States
Additional Information:
Study ID Numbers: HD041890-03; HD041919-01,HD041918-01,HD041915,HD041906-01,HD041908-01
Study Start Date: February 2003
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00069615
Other Diabetes Mellitus, Insulin-Dependent Studies:
1. Insulin Aspart vs. Insulin Lispro vs. Regular Insulin in Pediatric Population
2. Continuous Glucose Monitors for Children With Diabetes Mellitus
3. Safety and Pharmacokinetics (PK) of hOKT3g1 (Ala-Ala) in Type 1 Diabetes Mellitus (T1DM)
4. Continuous Glucose Monitoring in Children With Type 1 Diabetes Mellitus
5. hOKT3gamma1 (Ala-ala) for the prevention of human islet allograft failure
Related Studies:
Other Diabetes Mellitus, Insulin-Dependent Clinical Trials
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The GlucoWatch G2 Biographer for the Management of Type 1 Diabetes in Children
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