A randomized multicenter trial comparing the GlucoWatch Biographer with standard glucose monitoring in children with type 1 diabetes.
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.


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 > or =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.
Chase
H Peter
HP
DirecNet Coordinating Center, Jaeb Center for Health Research, 15310 Amberly Drive, Suite 350, Tampa, FL 33647, USA. direcnet@jaeb.org
Beck
Roy
R
Tamborlane
William
W
Buckingham
Bruce
B
Mauras
Nelly
N
Tsalikian
Eva
E
Wysocki
Tim
T
Weinzimer
Stuart
S
Kollman
Craig
C
Ruedy
Katrina
K
Xing
Dongyuan
D
D000293:Adolescent; D015190:Blood Glucose Self-Monitoring / Q000009:adverse effects / Q000295:instrumentation*; D002648:Child; D003922:Diabetes Mellitus, Type 1 / Q000097:blood* / Q000175:diagnosis*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007003:Hypoglycemia / Q000097:blood / Q000175:diagnosis / Q000517:prevention & control; D008297:Male; D008991:Monitoring, Physiologic / Q000009:adverse effects / Q000295:instrumentation; D017060:Patient Satisfaction; D012871:Skin Diseases / Q000209:etiology; D011795:Surveys and Questionnaires
D006442:Glycated Hemoglobin