Simplera™ CGM Accuracy in Diabetes Patients on Icodextrin Peritoneal Dialysis
Data Collection
Collected from today forward - ProspectiveUrogenital Diseases+16
+ Chronic Disease
+ Diabetes Mellitus
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: February 20, 2025
Actual date on which the first participant was enrolled.This study focuses on evaluating the accuracy of a specific continuous glucose monitoring system, the Medtronic Simplera™ CGM. The study involves diabetes patients who are undergoing a type of dialysis known as peritoneal dialysis, which uses a solution containing icodextrin. The main goal is to compare the performance of the Simplera™ CGM to a gold standard reference laboratory method for measuring glucose levels, called YSI glucose. This research is important as it aims to ensure the reliability of the Simplera™ CGM in this specific patient population, potentially improving their glucose management and overall care. During the study, participants will use the Simplera™ CGM while continuing their regular peritoneal dialysis regimen. The CGM system will monitor their glucose levels continuously. These results will then be compared with the results obtained from the YSI glucose method, which is currently considered a highly accurate way to measure glucose. The primary outcome of the study is to calculate the mean absolute relative difference (MARD) between the glucose readings from the Simplera™ CGM and the YSI glucose method. This comparison will help determine how closely the CGM readings match the YSI readings, indicating the accuracy of the Simplera™ CGM system.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Department of Medicine and Therapeutics, The Chinese University of Hong Kong
Hong Kong, Hong KongOpen Department of Medicine and Therapeutics, The Chinese University of Hong Kong in Google Maps