Continuous Glucose Monitoring and Clinical Outcomes in Diabetes on Peritoneal Dialysis (GLANCE-PD)
2026年8月24日 更新者：Elaine Chow
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.
研究概览
研究类型
观察性的
注册 (估计的)
100
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Elaine Chow
- 电话号码：+85235051549
- 邮箱：e.chow@cuhk.edu.hk
学习地点
-
-
-
Hong Kong、香港
- Department of Medicine and Therapeutics, The Chinese University of Hong Kong
-
接触：
- Elaine Chow
- 电话号码：+85235051549
- 邮箱：e.chow@cuhk.edu.hk
-
副研究员：
- Jack Kit Chung Ng
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
Adults with diabetes and stage 5 chronic kidney disease who are receiving peritoneal dialysis or are planned to initiate peritoneal dialysis within 3 months.
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
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
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Continuous glucose monitoring-derived metrics
大体时间：During period of 14 day CGM wear
|
CGM derived time in ranges
|
During period of 14 day CGM wear
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
HbA1c
大体时间：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
大体时间：Baseline through to month 12
|
24-hour dialysate and ultrafiltration volume,
|
Baseline through to month 12
|
|
Residual renal function
大体时间：From baseline through 12 months
|
Defined by 24-hour urine volume
|
From baseline through 12 months
|
|
Hospitalization for hyperglycemic or hypoglycemic emergencies
大体时间：From baseline through 12 months
|
Incidence of hospitalization due to hyperglycemic or hypoglycemic emergencies during follow-up
|
From baseline through 12 months
|
|
Hospitalizations, cardiovascular events, and all-cause mortality
大体时间：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
大体时间：During the 14-day CGM wear period
|
Dietary intake assessed using a 3-day food diary
|
During the 14-day CGM wear period
|
|
Health-related quality of life
大体时间：Baseline
|
EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) overall score
|
Baseline
|
|
Quality of life specific to kidney disease
大体时间：Baseline
|
Kidney Disease Quality of Life-36 questionnaire (KDQOL-36) total score
|
Baseline
|
|
CGM user satisfaction
大体时间：Baseline and month 3
|
Total score from 10-item CGM user satisfaction questionnaire
|
Baseline and month 3
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员：Elaine Chow、Department of Medicine and Therapeutics, The Chinese University of Hong Kong
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月31日
初级完成 (估计的)
2028年6月1日
研究完成 (估计的)
2028年9月1日
研究注册日期
首次提交
2026年8月21日
首先提交符合 QC 标准的
2026年8月24日
首次发布 (实际的)
2026年8月27日
研究记录更新
最后更新发布 (实际的)
2026年8月27日
上次提交的符合 QC 标准的更新
2026年8月24日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- GLANCE-PD
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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