A Phase 4 interventional study of GlucoWatch® G2™ Biographer (GW2B) and Continuous Glucose Monitoring System™ (CGMS) in Diabetes Mellitus, Insulin-Dependent, sponsored by Jaeb Center for Health Research. Completed at 6 sites in United States. Open to participants aged 7 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-05.
Sponsored by Jaeb Center for Health Research · Phase 4 and Interventional
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.
3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.
This study's enrollment of 15 is below the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Jaeb Center for Health Research is the lead sponsor of 129 studies on the registry; 16 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 15 (88%) have results posted.
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Exclusion Criteria
The presence of any of the following diseases:
Feasibility of using the GlucoWatch G2 Biographer
Feasibility of collecting data from home computers
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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