AIMS: To evaluate the accuracy of a (widely used) continuous glucose monitoring (CGM)-system and its ability to detect hypoglycaemic events. METHODS: A total of 18 patients with type 1 diabetes mellitus used continuous glucose monitoring (Guardian REAL-Time CGMS) during two 9-day in-house periods. A hypoglycaemic threshold alarm alerted patients to sensor readings <70 mg/dl. Continuous glucose monitoring sensor readings were compared to laboratory reference measurements taken every 4 h and in case of a hypoglycaemic alarm. RESULTS: A total of 2317 paired data points were evaluated. Overall, the mean absolute relative difference (MARD) was 16.7%. The percentage of data points in the clinically accurate or acceptable Clarke Error Grid zones A + B was 94.6%. In the hypoglycaemic range, accuracy worsened (MARD 38.8%) leading to a failure to detect more than half of the true hypoglycaemic events (sensitivity 37.5%). Furthermore, more than half of the alarms that warn patients for hypoglycaemia were false (false alert rate 53.3%). Above the low alert threshold, the sensor confirmed 2077 of 2182 reference values (specificity 95.2%). CONCLUSIONS: Patients using continuous glucose monitoring should be aware of its limitation to accurately detect hypoglycaemia.
AIMS: To evaluate the accuracy of a (widely used) continuous glucose monitoring (CGM)-system and its ability to detect hypoglycaemic events. METHODS: A total of 18 patients with type 1 diabetes mellitus used continuous glucose monitoring (Guardian REAL-Time CGMS) during two 9-day in-house periods. A hypoglycaemic threshold alarm alerted patients to sensor readings <70 mg/dl. Continuous glucose monitoring sensor readings were compared to laboratory reference measurements taken every 4 h and in case of a hypoglycaemic alarm. RESULTS: A total of 2317 paired data points were evaluated. Overall, the mean absolute relative difference (MARD) was 16.7%. The percentage of data points in the clinically accurate or acceptable Clarke Error Grid zones A + B was 94.6%. In the hypoglycaemic range, accuracy worsened (MARD 38.8%) leading to a failure to detect more than half of the true hypoglycaemic events (sensitivity 37.5%). Furthermore, more than half of the alarms that warn patients for hypoglycaemia were false (false alert rate 53.3%). Above the low alert threshold, the sensor confirmed 2077 of 2182 reference values (specificity 95.2%). CONCLUSIONS:Patients using continuous glucose monitoring should be aware of its limitation to accurately detect hypoglycaemia.
Authors: K Donsa; P Beck; J Plank; L Schaupp; J K Mader; T Truskaller; B Tschapeller; B Höll; S Spat; T R Pieber Journal: Appl Clin Inform Date: 2014-06-11 Impact factor: 2.342