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NCT Number: NCT07790276

Continuous Glucose Monitoring and Clinical Outcomes in Diabetes on Peritoneal Dialysis

This prospective, multicenter observational study will evaluate glucose profiles using continuous glucose monitoring (CGM) in 100 adults with diabetes receiving peritoneal dialysis (PD) or planning to start PD within 3 months. The study will examine associations between CGM metrics and PD regimen, glucose-lowering treatment, conventional glycemic markers, dialysis-related measures, and clinical outcomes including glycemic emergencies, hospitalizations, cardiovascular events, and mortality over 12 months.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stage 5 CKD patients
  • who have received PD for at least 3 months, OR
  • who are planned for PD within the next 3 months.
  • Age 18-80 years old
  • Known history of type 1 or type 2 diabetes for at least 3 months
  • 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.
  • 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.

Exclusion criteria

  • Patients who are planning to switch to hemodialysis or renal transplant in the coming 3 months
  • Life expectancy <6 months
  • Extensive skin changes/diseases that preclude wearing the required number of devices on normal skin at the proposed application sites
  • HbA1c > 11% at enrolment
  • 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.
  • 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.
  • Have a known allergy to medical-grade adhesives or known hypersensitivity to any of the products used in the study.
  • Have MRI scan, CT scan, or diathermy scheduled during the proposed period of sensor wearing during the study

Treatment and study plan

Continuous Glucose Monitoring System

Device

Sibionics GS3 CGM

Primary outcomes

  1. Continuous glucose monitoring-derived metrics

    Time frame: During period of 14 day CGM wear

    CGM derived time in ranges

Secondary outcomes

  1. HbA1c

    Time frame: Baseline to end of study period month 12

    HbA1c by venous blood

  2. 24-hour dialysate and ultrafiltration volume

    Time frame: Baseline through to month 12

    24-hour dialysate and ultrafiltration volume,

  3. Residual renal function

    Time frame: From baseline through 12 months

    Defined by 24-hour urine volume

  4. Hospitalization for hyperglycemic or hypoglycemic emergencies

    Time frame: From baseline through 12 months

    Incidence of hospitalization due to hyperglycemic or hypoglycemic emergencies during follow-up

  5. Hospitalizations, cardiovascular events, and all-cause mortality

    Time frame: From baseline through 12 months

    Incidence of all-cause hospitalization, major cardiovascular events, and all-cause mortality during follow-up

  6. Dietary intake during CGM wear

    Time frame: During the 14-day CGM wear period

    Dietary intake assessed using a 3-day food diary

  7. Health-related quality of life

    Time frame: Baseline

    EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) overall score

  8. Quality of life specific to kidney disease

    Time frame: Baseline

    Kidney Disease Quality of Life-36 questionnaire (KDQOL-36) total score

  9. CGM user satisfaction

    Time frame: Baseline and month 3

    Total score from 10-item CGM user satisfaction questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Elaine Chow

CONTACT

[email protected]

+85235051549

Sponsors and collaborators

Lead sponsor

Elaine Chow

Other

Registry information

Official study title

Glycemic Assessment Based on Continuous Glucose Monitoring and Clinical Outcomes in People With Diabetes on Peritoneal Dialysis: a Multi-centered Prospective Study

Acronym: GLANCE-PD

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 27, 2026
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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