Detection of hypoglycemia with the GlucoWatch biographer.
OBJECTIVE
Hypoglycemia is a common acute complication of diabetes therapy. The GlucoWatch biographer provides frequent and automatic glucose measurements with an adjustable low-glucose alarm. We have analyzed the performance of the biographer low-glucose alarm relative to hypoglycemia as defined by blood glucose < or = 3.9 mmol/l.


METHODS
The analysis was based on 1,091 biographer uses from four clinical trials. which generated 14,487 paired (biographer and blood glucose) readings.


RESULTS
The results show that as the low-glucose alert level of the biographer is increased, the number of true positive alerts (alarm sounds and blood glucose < or = 3.9 mmol/l) and false positive alerts (alarm sounds but blood glucose >3.9 mmol/l) increased. When analyzed as a function of varying low-glucose alert levels, the results show receiver operator characteristic curves consistent with a highly useful diagnostic tool. Setting the alert level from 1.1 to 1.7 mmol/l above the level of concern is likely to optimize the trade-off between true positives and false positives for each user. When the same blood glucose data are analyzed for typical monitoring practices (two or four measurements per day), the results show that fewer hypoglycemic events are detected than those detected with the biographer.
Pitzer
K R
KR
Cygnus Incorporated, Redwood City, California 94063, USA. kpitzer@cygn.com
Desai
S
S
Dunn
T
T
Edelman
S
S
Jayalakshmi
Y
Y
Kennedy
J
J
Tamada
J A
JA
Potts
R O
RO
D001331:Automation; D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation* / Q000379:methods; D005188:False Negative Reactions; D005189:False Positive Reactions; D006801:Humans; D007003:Hypoglycemia / Q000097:blood / Q000175:diagnosis* / Q000517:prevention & control; D007004:Hypoglycemic Agents / Q000009:adverse effects; D018670:Monitoring, Ambulatory / Q000295:instrumentation* / Q000379:methods; D012372:ROC Curve; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D001786:Blood Glucose; D007004:Hypoglycemic Agents