NCT07790276

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
24mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 27, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

August 31, 2026

Expected
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

1.8 years

First QC Date

August 21, 2026

Last Update Submit

August 24, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Continuous glucose monitoring-derived metrics

    CGM derived time in ranges

    During period of 14 day CGM wear

Secondary Outcomes (9)

  • HbA1c

    Baseline to end of study period month 12

  • 24-hour dialysate and ultrafiltration volume

    Baseline through to month 12

  • Residual renal function

    From baseline through 12 months

  • Hospitalization for hyperglycemic or hypoglycemic emergencies

    From baseline through 12 months

  • Hospitalizations, cardiovascular events, and all-cause mortality

    From baseline through 12 months

  • +4 more secondary outcomes

Study Arms (2)

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

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

Interventions

Sibionics GS3 CGM

peritoneal dialysis grouppre-peritoneal dialysis group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicDiabetes Mellitus

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicInvestigative Techniques

Study Officials

  • Elaine Chow

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

August 21, 2026

First Posted

August 27, 2026

Study Start (Estimated)

August 31, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

August 27, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations