Continuous Glucose Monitoring and Clinical Outcomes in Diabetes on Peritoneal Dialysis

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorElaine Chow

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Continuous glucose monitoring system

    Device

    Sibionics GS3 CGM

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: peritoneal dialysis group1 intervention
Group B: pre-peritoneal dialysis group1 intervention

Trial outcomes

Primary outcomes

1

Continuous glucose monitoring-derived metrics

CGM derived time in ranges

Time frame
During period of 14 day CGM wear

Secondary outcomes

1

HbA1c

HbA1c by venous blood

Time frame
Baseline to end of study period month 12
2

24-hour dialysate and ultrafiltration volume

24-hour dialysate and ultrafiltration volume,

Time frame
Baseline through to month 12
3

Residual renal function

Defined by 24-hour urine volume

Time frame
From baseline through 12 months
4

Hospitalization for hyperglycemic or hypoglycemic emergencies

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

Time frame
From baseline through 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Elaine Chow

Lead sponsor

Chinese University of Hong Kong

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: