CGM in Icodextrin PD

February 17, 2025 updated by: Elaine Chow

Evaluation of Accuracy of Medtronic Simplera™ CGM in Patients on Icodextrin-containing Peritoneal Dialysis Regimens

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Elaine Chow Clinical Associate Professor, MBChB
  • Phone Number: +85235051549
  • Email: e.chow@cuhk.edu.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Department of Medicine and Therapeutics, The Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Diabetes patients on continuous ambulatory peritoneal dialysis on icodextrin

Description

Inclusion Criteria:

  1. Type 1 or 2 diabetes mellitus for at least 3 months
  2. On continuous ambulatory peritoneal dialysis (CAPD) or APD for at least 2 months
  3. On icodextrin PD solutions for at least 1 month or planned for switching to icodextrin PD solutions within 3 months of screening
  4. Male or female age ≥ 18 years old and ≤ 75 year old.
  5. Women who are not pregnant, lactating or planning a pregnancy during their participation in the clinical study.
  6. Willingness, ability and commitment to comply with the testing, procedure and follow-up outlined in this protocol including (but not limited to) frequency of clinic visits and use of pre-specified glucose monitoring devices.
  7. Willingness to abstain from swimming during their participation in the measurement phase.
  8. In the opinion of the investigator, absence of any physical limitations, addictive diseases, or underlying medical conditions (including mental health) that may preclude the patient from being a good study candidate.
  9. Written informed consent to participate in the study provided by the patient.

Exclusion Criteria:

  1. Poorly controlled diabetes mellitus with HbA1c>11%
  2. Peritonitis within 1 month of screening
  3. Planned for switching to hemodialysis or living donor transplant in the future 1 month
  4. Currently pregnant, as demonstrated by a positive pregnancy test at screening for women of reproductive potential
  5. Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study.
  6. Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff.
  7. Current use or recent exposure to any medication that in the opinion of the investigator could have an influence on the patient's ability to participate in this study or on the performance of the test device.
  8. Extensive skin changes/diseases that preclude wearing the required number of devices on normal skin at the proposed application sites (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis).
  9. Have a known allergy to medical-grade adhesives, or known hypersensitivity to any of the products used in the study.
  10. Blood donation of more than 500 ml within the last three months
  11. Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection.
  12. Has a MRI scan, CT scan, or diathermy scheduled during the proposed study participation.
  13. An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner).
  14. Women of reproductive potential who are unwilling to adopt contraceptive measures during the study period
  15. Patients with history of pacemaker and prosthesis implantation.
  16. Continuous use of real-time CGM for personal diabetes management in the three months prior to screening (sensor use >80% of time)

Study Plan

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

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean absolute relative difference (MARD)
Time Frame: 5 minutes
MARD of sensor versus YSI glucose
5 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Median absolute relative difference (MedARD)
Time Frame: 5 minutes
MedARD of sensor versus YSI glucose
5 minutes
Consensus Error grid analysis
Time Frame: 5 minutes
% sensor values in regions A and B
5 minutes
Hypoglycemia detection rates
Time Frame: 15 minutes
True and false hypoglycemia notification rate, correct and missed hypoglycemia detection rate
15 minutes
Hyperglycemia detection rates
Time Frame: 15 minutes
True and false hyperglycemia notification rate, correct and missed hyperglycemia detection rates
15 minutes
Correlation between CGM metrics, HbA1c and fructosamine
Time Frame: 2 weeks
Correlation between CGM metrics, HbA1c and fructosamine
2 weeks
Percent accuracy
Time Frame: 5 minutes
System readings within 15%, 20%, 30%, 40% and greater than 40% of YSI value
5 minutes
User satisfaction
Time Frame: 2 weeks
Diabetes Satisfaction Treatment Questionnaire score Time Frame: 2 weeks and
2 weeks
Correlation between CGM metrics and SMBG
Time Frame: 2 weeks
Correlation between CGM metrics and SMBG
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Elaine Chow

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medtronic Diabetes

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elaine Chow Clinical Associate Professor, PhD, MBChB, Department of Medicine and Therapeutics, The Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 20, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 20, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IcoSimplera

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings