Continuous Glucose Monitoring in Dialysis Patients to Overcome Dysglycemia Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Percent (%) of time in target glucose range (70-180 mg/dl)
研究概览
简要总结
This randomized controlled trial will investigate whether use of continuous glucose monitoring (CGM) vs. usual care with self-monitored blood glucose 1) enhances glycemic control, 2) reduces hypoglycemia risk, and 3) improves quality of life, diabetes distress, and fear of hypoglycemia in hemodialysis patients with diabetes mellitus.
详细描述
This is a parallel, two-arm randomized controlled trial comparing real-time CGM using Dexcom devices vs. usual care (self-monitored blood glucose 4-times/day) among 122 in-center hemodialysis patients with diabetes mellitus over a 12-week period. Our primary objective will be to determine the effects of CGM vs. usual care on glycemic control, defined by percent (%) of time in target glucose range (70-180 mg/dl). Our main and exploratory secondary objectives will be to determine the effects of CGM on CGM-indices of hypoglycemia, blood-based glycemic markers (HbA1c, glycated albumin, fructosamine), and patient-reported outcomes (health-related quality of life, diabetes distress, hypoglycemia fear). We will also evaluate feasibility endpoints by measuring CGM compliance during the intervention period and success/ease of implementing CGM training sessions among patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide written informed consent
- •Age ≥18 years old
- •End-stage kidney disease status receiving in-center hemodialysis ≥4 weeks
- •Type 1 or type 2 diabetes
- •Actively performing self-monitored blood glucose (SMBG) testing for ≥4 weeks
- •≥70% compliance wearing continuous glucose monitoring (CGM) device during the pre-trial period
排除标准
- •Inability to provide informed consent or comply with the study protocol
- •Limited visual acuity
- •Inability to wear CGM device
- •Prior use of CGM
- •Active pregnancy or planning a pregnancy
研究组 & 干预措施
Continuous glucose monitoring (CGM) arm
During the intervention period, patients in the CGM arm will undergo continuous real-time "unblinded" CGM using Dexcom CGM devices.
干预措施: Continuous glucose monitoring (CGM) (Device)
Usual care arm
During the intervention period, patients in the usual care arm will conduct self-monitored blood glucose (SMBG) at least 4 times/day. At Weeks 6 and 12 of the intervention period, usual care arm patients will also undergo 10-days of blinded CGM data collection.
干预措施: Usual care (Self-monitored blood glucose) (Device)
结局指标
主要结局
Percent (%) of time in target glucose range (70-180 mg/dl)
时间窗: 12 weeks
Ascertained by continous glucose monitoring
次要结局
- Percent (%) of time spent in hypoglycemia (<70 mg/dl)(12 weeks)
- Glycemic variability(12 weeks)
- Percent (%) of time spent in relative hypoglycemia (<100 mg/dl)(12 weeks)
- Hemoglobin A1c level(12 weeks)
- Glycated albumin level(12 weeks)
- Diabetes Distress Scale Survey Score(12 weeks)
- Fructosamine level(12 weeks)
- Short Form 36 Survey Physical Component Summary Score(12 weeks)
- Hypoglycemia Fear(12 weeks)
研究者
Connie Rhee
Professor of Medicine
University of California, Irvine