Diabetes Mellitus, Insulin-Dependent Clinical Trial
Official title:
DirecNet Pilot Study to Evaluate the GlucoWatch G2 Biographer in the Management of Type 1 Diabetes in Children
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.
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.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
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