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
Type 1 or 2 diabetes mellitus for at least 3 months
On continuous ambulatory peritoneal dialysis (CAPD) or APD for at least 2 months
On icodextrin PD solutions for at least 1 month or planned for switching to icodextrin PD solutions within 3 months of screening
Male or female age ≥ 18 years old and ≤ 75 year old.
Poorly controlled diabetes mellitus with HbA1c>11%
Peritonitis within 1 month of screening
Planned for switching to hemodialysis or living donor transplant in the future 1 month
Currently pregnant, as demonstrated by a positive pregnancy test at screening for women of reproductive potential
Diabetes patients on continuous ambulatory peritoneal dialysis on icodextrin
Cohort
Prospective
Continuous glucose monitoring system
DeviceMedtronic Simplera™
Mean absolute relative difference (MARD)
MARD of sensor versus YSI glucose
Median absolute relative difference (MedARD)
MedARD of sensor versus YSI glucose
Consensus Error grid analysis
% sensor values in regions A and B
Percent accuracy
System readings within 15%, 20%, 30%, 40% and greater than 40% of YSI value
Hypoglycemia detection rates
True and false hypoglycemia notification rate, correct and missed hypoglycemia detection rate
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Elaine Chow
Lead sponsor
Chinese University of Hong Kong
Sponsor institution
Medtronic MiniMed, Inc.
Collaborator
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