Performance of the DIDGET blood glucose monitoring system in children, teens, and young adults.
BACKGROUND
This study evaluated the performance of the DIDGET® blood glucose monitoring system (BGMS) in the hands of its intended users: children, teens, and young adults with diabetes.


METHODS
Finger stick capillary blood samples were tested in duplicate by subjects (with parent/guardian assistance, if needed) and health care professionals using the DIDGET BGMS, and results were compared with those obtained using a Yellow Springs Instruments (YSI) glucose analyzer. Modified venous blood samples (i.e., glycolyzed or spiked with glucose) were used to analyze meter performance under extreme glucose concentrations. Accuracy was assessed using International Organization for Standardization (ISO) 15197:2003 guidelines (i.e., 95% of meter results within ±15 mg/dl or ±20% of reference values).


RESULTS
A total of 123 subjects aged 4 to 24 years with type 1 or type 2 diabetes were enrolled. The DIDGET meter achieved accuracy according to ISO 15197:2003 criteria: >97% of meter results were within ±15 mg/dl or ±20% of reference values. Regression analyses showed a high degree of correlation between meter and YSI results: coefficient of determination (R(2)) = 98.2% for all samples combined and 97.2% for capillary samples only. Clinical accuracy for combined samples was demonstrated by Parkes consensus error grid analyses; 100% of meter results were in zone A (98.5%) or zone B (1.5%). There was no difference in performance or accuracy across age subsets. Hematocrit values did not affect meter blood glucose results.


CONCLUSIONS
The DIDGET BGMS provided accurate test results across all age ranges in children, teens, and young adults with diabetes.
Florida State University College of Medicine, Tallahassee, Florida 32308, USA. lcdeeb@deeb.org
Larry C
LC
Deeb
Joan L
JL
Parkes
Scott
S
Pardo
Holly C
HC
Schachner
Maria T
MT
Viggiani
Jane
J
Wallace
Timothy
T
Bailey
D000293:Adolescent; D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation* / Q000592:standards; D001800:Blood Specimen Collection / Q000295:instrumentation / Q000592:standards; D002648:Child; D002675:Child, Preschool; D003922:Diabetes Mellitus, Type 1 / Q000097:blood*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood*; D005260:Female; D006801:Humans; D008297:Male; D012016:Reference Values; D015203:Reproducibility of Results; D055815:Young Adult
D001786:Blood Glucose