Department of Medicine and Therapeutics, The Chinese University of Hong Kong
Hong Kong
NCT Number: NCT06838819
Assessment of performance (precision and accuracy) of Simplera™ CGM as compared with a gold standard reference laboratory method (YSI glucose) in diabetes patients on peritoneal dialysis with icodextrin
Trial opening soon.
Get Notified18 year–75 year
All sexes
Observational
Hong Kong
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Medtronic Simplera™
Time frame: 5 minutes
MARD of sensor versus YSI glucose
Time frame: 5 minutes
MedARD of sensor versus YSI glucose
Time frame: 5 minutes
% sensor values in regions A and B
Time frame: 5 minutes
System readings within 15%, 20%, 30%, 40% and greater than 40% of YSI value
Time frame: 15 minutes
True and false hypoglycemia notification rate, correct and missed hypoglycemia detection rate
Time frame: 15 minutes
True and false hyperglycemia notification rate, correct and missed hyperglycemia detection rates
Time frame: 2 weeks
Diabetes Satisfaction Treatment Questionnaire score Time Frame: 2 weeks and
Time frame: 2 weeks
Correlation between CGM metrics, HbA1c and fructosamine
Time frame: 2 weeks
Correlation between CGM metrics and SMBG
Contact information is provided by the study sponsor or research team.
Elaine Chow
Other
Evaluation of Accuracy of Medtronic Simplera™ CGM in Patients on Icodextrin-containing Peritoneal Dialysis Regimens
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