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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: Elaine Chow
- Phone Number: +85235051549
- Email: e.chow@cuhk.edu.hk
Study Locations
-
-
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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
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / 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.
|
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.
|
Sibionics GS3 CGM
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Continuous glucose monitoring-derived metrics
Time Frame: During period of 14 day CGM wear
|
CGM derived time in ranges
|
During period of 14 day CGM wear
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HbA1c
Time Frame: Baseline to end of study period month 12
|
HbA1c by venous blood
|
Baseline to end of study period month 12
|
|
24-hour dialysate and ultrafiltration volume
Time Frame: Baseline through to month 12
|
24-hour dialysate and ultrafiltration volume,
|
Baseline through to month 12
|
|
Residual renal function
Time Frame: From baseline through 12 months
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Defined by 24-hour urine volume
|
From baseline through 12 months
|
|
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
|
From baseline through 12 months
|
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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
|
From baseline through 12 months
|
|
Dietary intake during CGM wear
Time Frame: During the 14-day CGM wear period
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Dietary intake assessed using a 3-day food diary
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During the 14-day CGM wear period
|
|
Health-related quality of life
Time Frame: Baseline
|
EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) overall score
|
Baseline
|
|
Quality of life specific to kidney disease
Time Frame: Baseline
|
Kidney Disease Quality of Life-36 questionnaire (KDQOL-36) total score
|
Baseline
|
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CGM user satisfaction
Time Frame: Baseline and month 3
|
Total score from 10-item CGM user satisfaction questionnaire
|
Baseline and month 3
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
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)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
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
Other Study ID Numbers
- GLANCE-PD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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