Continuous Glucose Monitoring and Clinical Outcomes in Diabetes on Peritoneal Dialysis (GLANCE-PD)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: ESRD (End-Stage Renal Disease); Continuous Glucose Monitoring; Diabetes Mellitus (DM); Peritoneal Dialysis (PD)
• Intervention / Treatment: Device: Continuous glucose monitoring system

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Elaine Chow; 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
    • Contact: Elaine Chow; Phone Number: +85235051549; Email: e.chow@cuhk.edu.hk
    • Sub-Investigator: Jack Kit Chung Ng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults with diabetes and stage 5 chronic kidney disease who are receiving peritoneal dialysis or are planned to initiate peritoneal dialysis within 3 months.

Description

Inclusion criteria:

1. Stage 5 CKD patients

   1. who have received PD for at least 3 months, OR
   2. who are planned for PD within the next 3 months.
2. Age 18-80 years old
3. Known history of type 1 or type 2 diabetes for at least 3 months
4. Women who are not pregnant, lactating or planning a pregnancy during their participation in the clinical study.
5. 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.
6. Willingness to abstain from swimming during their participation in the measurement phase.
7. 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.
8. Written informed consent to participate in the study provided by the patient.

Exclusion criteria:

1. Patients who are planning to switch to hemodialysis or renal transplant in the coming 3 months
2. Life expectancy <6 months
3. Extensive skin changes/diseases that preclude wearing the required number of devices on normal skin at the proposed application sites
4. HbA1c > 11% at enrolment
5. Currently pregnant, as demonstrated by a positive pregnancy test at screening for women of reproductive potential.
6. Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study.
7. Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff.
8. 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.
9. Have a known allergy to medical-grade adhesives or known hypersensitivity to any of the products used in the study.
10. Have MRI scan, CT scan, or diathermy scheduled during the proposed period of sensor wearing during the study

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
peritoneal dialysis group; Adults with diabetes and stage 5 chronic kidney disease who have been receiving peritoneal dialysis for at least 3 months at enrollment.	Device: Continuous glucose monitoring system; Sibionics GS3 CGM
pre-peritoneal dialysis group; Adults with diabetes and stage 5 chronic kidney disease who are planned to initiate peritoneal dialysis within 3 months after enrollment.	Device: Continuous glucose monitoring system; Sibionics GS3 CGM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuous glucose monitoring-derived metrics	CGM derived time in ranges	During period of 14 day CGM wear

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	HbA1c by venous blood	Baseline to end of study period month 12
24-hour dialysate and ultrafiltration volume	24-hour dialysate and ultrafiltration volume,	Baseline through to month 12
Residual renal function	Defined by 24-hour urine volume	From baseline through 12 months
Hospitalization for hyperglycemic or hypoglycemic emergencies	Incidence of hospitalization due to hyperglycemic or hypoglycemic emergencies during follow-up	From baseline through 12 months
Hospitalizations, cardiovascular events, and all-cause mortality	Incidence of all-cause hospitalization, major cardiovascular events, and all-cause mortality during follow-up	From baseline through 12 months
Dietary intake during CGM wear	Dietary intake assessed using a 3-day food diary	During the 14-day CGM wear period
Health-related quality of life	EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) overall score	Baseline
Quality of life specific to kidney disease	Kidney Disease Quality of Life-36 questionnaire (KDQOL-36) total score	Baseline
CGM user satisfaction	Total score from 10-item CGM user satisfaction questionnaire	Baseline and month 3

Collaborators and Investigators

• Sponsor: Elaine Chow
• Investigators: Principal Investigator: Elaine Chow, Department of Medicine and Therapeutics, The Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: August 21, 2026
• First Submitted That Met QC Criteria: August 24, 2026
• First Posted (Actual): August 27, 2026

Study Record Updates

• Last Update Posted (Actual): August 27, 2026
• Last Update Submitted That Met QC Criteria: August 24, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Metabolic Diseases; Glucose Metabolism Disorders; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Diabetes Mellitus; Renal Insufficiency, Chronic; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Blood Chemical Analysis; Clinical Chemistry Tests; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Continuous Glucose Monitoring
• Other Study ID Numbers: GLANCE-PD

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