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Diabetes Mellitus (Diagnosis)NCT06838819

CGM in Icodextrin PD

An observational study of Diabetes Mellitus (Diagnosis) and End Stage Renal Disease (ESRD), run by Elaine Chow at 1 site in Hong Kong.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Continuous glucose monitoring system
Type of treatment
Medical device
How many people
30 participants
Where
1 siteHong Kong
Study dates
20 Feb 2025to 20 Sep 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Diabetes patients on continuous ambulatory peritoneal dialysis on icodextrin

Who may be able to join

  • 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.
  • Women who are not pregnant, lactating or planning a pregnancy during their participation in the clinical study.
  • 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.
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  • Willingness to abstain from swimming during their participation in the measurement phase.
  • 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.
  • Written informed consent to participate in the study provided by the patient.

Who cannot join

  • 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
  • Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study.
  • Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff.
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  • 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.
  • 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).
  • Have a known allergy to medical-grade adhesives, or known hypersensitivity to any of the products used in the study.
  • Blood donation of more than 500 ml within the last three months
  • Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection.
  • Has a MRI scan, CT scan, or diathermy scheduled during the proposed study participation.
  • An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner).
  • Women of reproductive potential who are unwilling to adopt contraceptive measures during the study period
  • Patients with history of pacemaker and prosthesis implantation.
  • Continuous use of real-time CGM for personal diabetes management in the three months prior to screening (sensor use >80% of time)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Elaine Chow Clinical Associate Professor, MBChB contact

+85235051549

e.chow@cuhk.edu.hk

Hong Kong1 site

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

    Hong Kong

Other trials in Hong Kong

About this study

Official title: 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

Being tested
Continuous glucose monitoring system
Medical subject headings
Diabetes Mellitus, Disease, Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuous glucose monitoring systemDevice

    Medtronic Simplera™

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean absolute relative difference (MARD)

    MARD of sensor versus YSI glucose

    Measured: 5 minutes

Secondary outcomes (8)

  1. Median absolute relative difference (MedARD)

    MedARD of sensor versus YSI glucose

    Measured: 5 minutes

  2. Consensus Error grid analysis

    % sensor values in regions A and B

    Measured: 5 minutes

  3. Percent accuracy

    System readings within 15%, 20%, 30%, 40% and greater than 40% of YSI value

    Measured: 5 minutes

  4. Hypoglycemia detection rates

    True and false hypoglycemia notification rate, correct and missed hypoglycemia detection rate

    Measured: 15 minutes

  5. Hyperglycemia detection rates

    True and false hyperglycemia notification rate, correct and missed hyperglycemia detection rates

    Measured: 15 minutes

  6. User satisfaction

    Diabetes Satisfaction Treatment Questionnaire score Time Frame: 2 weeks and

    Measured: 2 weeks

  7. Correlation between CGM metrics, HbA1c and fructosamine

    Correlation between CGM metrics, HbA1c and fructosamine

    Measured: 2 weeks

  8. Correlation between CGM metrics and SMBG

    Correlation between CGM metrics and SMBG

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2025
  2. Study start20 Feb 2025 (estimated)
  3. Primary completion20 Aug 2026 (estimated)
  4. Study completion20 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06838819
Sponsor's protocol ID
IcoSimplera
Status last verified
Feb 2025
First submitted
17 Feb 2025
Last updated
21 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus (Diagnosis) and End Stage Renal Disease (ESRD), run by Elaine Chow at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Elaine Chow Clinical Associate Professor, MBChB (+85235051549, e.chow@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean absolute relative difference (MARD) (time frame: 5 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06838819.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.

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