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Simplera™ CGM Accuracy in Diabetes Patients on Icodextrin Peritoneal Dialysis

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Urogenital Diseases+16

+ Chronic Disease

+ Diabetes Mellitus

From 18 to 75 Years
+25 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: February 2025
See protocol details

Summary

Principal SponsorElaine Chow
Study ContactElaine Chow Clinical Associate Professor, MBChB
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleEvaluation of Accuracy of Medtronic Simplera™ CGM in Patients on Icodextrin-containing Peritoneal Dialysis Regimens
NCT06838819
Principal SponsorElaine Chow
Study ContactElaine Chow Clinical Associate Professor, MBChB
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Urogenital DiseasesChronic DiseaseDiabetes MellitusDiseaseEndocrine System DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesKidney Failure, ChronicMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesDisease AttributesGlucose Metabolism DisordersRenal Insufficiency, ChronicRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

9 inclusion criteria required to participate
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.

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16 exclusion criteria prevent from participating
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

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

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

Suspended

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
Recruiting soonOne Study Center
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