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A Randomized Multicenter Trial Comparing the GlucoWatch Biographer With Standard Glucose Monitoring in Children With Type 1 Diabetes

Address correspondence and reprint requests to H. Peter Chase, MD, c/o DirecNet Coordinating Center, Jaeb Center for Health Research, 15310 Amberly Dr., Suite 350, Tampa, FL 33647. E-mail: direcnet{at}jaeb.org

OBJECTIVE—This study assesses whether use of the GlucoWatch G2 Biographer (GW2B) in addition to standard glucose monitoring lowers HbA_1c and reduces hypoglycemia compared with standard glucose monitoring alone.

RESEARCH DESIGN AND METHODS—In all, 200 subjects aged 7 to <18 years with type 1 diabetes were randomly assigned at five centers to standard glucose monitoring (usual care) or standard glucose monitoring plus GW2B use for 6 months. Study outcomes included HbA_1c values obtained at 6 months and occurrence of severe hypoglycemia.

RESULTS—The mean HbA_1c at baseline was 8.0% in both groups; at 6 months, HbA_1c was 7.9% in the usual care group and 8.1% in the GW2B group (95% CI for mean reduction in the GW2B group compared with the usual care group –0.4 to 0.1%; P = 0.15). A decrease in HbA_1c of 0.5% was achieved in 21% of the usual care group and 28% of the GW2B group (P = 0.29). Severe hypoglycemia events occurred in 7% of the GW2B group and in 2% of the usual care group (P = 0.10). In the GW2B group, sensor use declined throughout the study from a mean value of 2.1 times/week in the 1st month to 1.5 times/week in the 6th month. Reasons given for declining use included skin irritation (76%), frequent skips (56%), excessive alarms (47%), and inaccurate readings (33%).

CONCLUSIONS—Use of the GW2B in addition to standard glucose monitoring did not improve glycemic control or reduce the frequency of severe hypoglycemia. Skin reactions and other problems led to decreasing sensor use over time.

Abbreviations: CGMS, continuous glucose monitoring system • DirecNet, Diabetes Research in Children Network • GW2B, GlucoWatch G2 Biographer

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