Continuous Glucose Monitoring for Post-discharge Diabetes Management
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- time in range 70-180 mg/dl
研究概览
简要总结
This is an investigator initiated prospective, randomized controlled trial which aims to compare two groups of patients with either type 2 or steroid-induced diabetes who are discharged with insulin. The intervention group will use the Libre 3 Plus continuous glucose monitoring (CGM) system at discharge, while the control group will use blinded CGM and fingerstick monitoring. Both the intervention and control groups will wear the sensor for 28 days post discharge and participate in telehealth diabetes management visits. The target enrollment for the study is 65 participants and participants are expected to be in the study for up to 35 days.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult 18 years or older.
- •Inpatient treatment for type 2 or steroid induced diabetes during hospitalization, with plan for insulin use after discharge.
排除标准
- •Type 1 diabetes
- •Plan for discharge to rehabilitation/skilled nursing/hospice facility
- •Contra-indication to sensor placement
- •Pregnancy
研究组 & 干预措施
Libre 3 Plus continuous glucose monitoring (CGM) system
use of unmasked continuous glucose monitoring
干预措施: Libre 3 Plus continuous glucose monitoring (CGM) system (Device)
Blinded CGM and fingerstick monitoring
Self-monitoring blood glucose (SMBG)+masked CGM
干预措施: Blinded Continuous Glucose Monitoring (Device)
Blinded CGM and fingerstick monitoring
Self-monitoring blood glucose (SMBG)+masked CGM
干预措施: Finger stick (Behavioral)
结局指标
主要结局
time in range 70-180 mg/dl
时间窗: Day 20-30
percent time in range for last 10 days of study
次要结局
- Percent time <54mg/dL(Day 30)
- 30 day time in range(Day 30)
- Percent time >180mg/dL(Day 30)
- Percent time >250mg/dL(Day 30)
- Percent time <70mg/dL(Day 30)
研究者
Grenye O'Malley
Associate Professor
Icahn School of Medicine at Mount Sinai
