Assessment of performance (precision and accuracy) of Guardian Sensor™ 3 as compared with a gold standard reference laboratory method (YSI glucose) in diabetes patients on peritoneal dialysis.
Study Type
OBSERVATIONAL
Enrollment
30
Medtronic Guardian Connect with Guardian Sensor 3
Elaine Chow
Hong Kong, None Selected, China
Mean absolute relative difference (MARD)
MARD of sensor versus YSI glucose
Time frame: 5 minutes
Median absolute relative difference (MedARD)
MedARD of sensor versus YSI glucose
Time frame: 5 minutes
Consensus Error grid analysis
% sensor values in regions A and B
Time frame: 5 minutes
Percent accuracy
System readings within 15%, 20%, 30%, 40% and greater than 40% of YSI values
Time frame: 5 minutes
Hypoglycemia detection rates
True and false hypoglycemia notification rate, correct and missed hypoglycemia detection rate
Time frame: 15 minutes
Hyperglycemia detection rates
True and false hyperglycemia notification rate, correct and missed hyperglycemia detection rates
Time frame: 15 minutes
User satisfaction
Diabetes Satisfaction Treatment Questionnaire score
Time frame: 2 weeks
Correlation between CGM metrics, HbA1c and fructosamine
Correlation between CGM metrics, HbA1c and fructosamine
Time frame: 2 weeks
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