Continuous Glucose Monitoring, Diabetes Mellitus (DM), ESRD (End-Stage Renal Disease), Peritoneal Dialysis (PD)
Conditions
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.
Interventions
DEVICEContinuous glucose monitoring system
Sibionics GS3 CGM
Sponsors
Elaine Chow
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Continuous glucose monitoring-derived metrics | During period of 14 day CGM wear | CGM derived time in ranges |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | Baseline to end of study period month 12 | HbA1c by venous blood |
| 24-hour dialysate and ultrafiltration volume | Baseline through to month 12 | 24-hour dialysate and ultrafiltration volume, |
| Residual renal function | From baseline through 12 months | Defined by 24-hour urine volume |
| Hospitalization for hyperglycemic or hypoglycemic emergencies | From baseline through 12 months | Incidence of hospitalization due to hyperglycemic or hypoglycemic emergencies during follow-up |
| Hospitalizations, cardiovascular events, and all-cause mortality | From baseline through 12 months | Incidence of all-cause hospitalization, major cardiovascular events, and all-cause mortality during follow-up |
| Dietary intake during CGM wear | During the 14-day CGM wear period | Dietary intake assessed using a 3-day food diary |
| Health-related quality of life | Baseline | EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) overall score |
| Quality of life specific to kidney disease | Baseline | Kidney Disease Quality of Life-36 questionnaire (KDQOL-36) total score |
| CGM user satisfaction | Baseline and month 3 | Total score from 10-item CGM user satisfaction questionnaire |
Countries
Hong Kong
Contacts
CONTACTElaine Chow
PRINCIPAL_INVESTIGATORElaine Chow
Department of Medicine and Therapeutics, The Chinese University of Hong Kong
Outcome results
None listed