Continuous Glucose Monitoring Initiation at Hospital Discharge: A Feasibility Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- To Determine the Feasibility of Initiating a Continuous Glucose Monitoring in Patients With Diabetes at Hospital Discharge
研究概览
简要总结
The purpose of this study is to look at feasibility (the likelihood) of continued use of the FreeStyle Libre 2 Continuous glucose monitor (CGM) when started at the time of hospital discharge in patients with poorly controlled diabetes and to look at the effects of CGM use on blood glucose control and quality of life. Additional information will be collected to determine the barriers to continuing CGM use after discharge. The investigators will also collect information to see how well blood glucose has been controlled after discharge while utilizing the CGM.
详细描述
VISIT/PHONE CALL WHAT WILL HAPPEN? (estimated time) [window]
Screening Visit (~45 minutes) Review consent form and obtain consent Complete questionnaire, obtain diabetes history Day of Discharge (~1 hour) Complete FreeStyle Libre 2 CGM education Attach FreeStyle Libre 2 CGM sensor to arm Within 1-3 weeks from discharge Phone Call (~30 minutes) Questions regarding use of FreeStyle Libre 2 CGM Current diabetes regimen Adverse Events Reminder to take FreeStyle Libre 2 CGM sensor prescription to pharmacy to be filled
1 & 3 Month Phone Call (~45 minutes) [+/- 5 days] Questions regarding use of FreeStyle Libre 2 CGM Current diabetes regimen Complete questionnaire Adverse Events 6 Month Phone Call (~15 minutes) [+/- 10 days] Questions regarding use of FreeStyle Libre 2 CGM Barriers to FreeStyle Libre 2 CGM use
Validated Instruments: Diabetes self-management Questionnaire (DMSQ)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •18 years of age or older
- •Have diabetes (type 1 diabetes mellitus, type 2 diabetes mellitus, cystic fibrosis related diabetes mellitus)
- •Hemoglobin A1c greater than or equal to 8.0% or history of hypoglycemia unawareness
- •Able and willing to sign informed consent form
- •Have a valid telephone number
- •Willing to purchase FreeStyle Libre 2 CGM sensors out of pocket after discharge from hospital (when insurance coverage isn't available)
排除标准
- •Unable to sign informed consent form
- •Have altered mental status
- •Unable to manage diabetes independently at home
- •Have utilized CGM in the past
- •New steroid-induced hyperglycemia
- •Unwilling to participate in the study
- •Have kidney disease requiring hemodialysis
- •Taking high doses of vitamin C daily (greater than 500 mg every day)
研究组 & 干预措施
CGM Intervention
All eligible patients will receive a Continuous Glucose Monitor (CGM) prior to hospital discharge after signing an informed consent.
干预措施: CGM4Home (Device)
结局指标
主要结局
To Determine the Feasibility of Initiating a Continuous Glucose Monitoring in Patients With Diabetes at Hospital Discharge
时间窗: At 3 months
Starting and continuing to use a CGM at this critical time is feasible. Feasibility is defined as at least 20 percent of patients with diabetes referred for diabetes education meet inclusion criteria to participate and at least 75 percent participate. From those who participate, at least 50 percent continue using the CGM at 3 months.
次要结局
- Percentage of Patients That Discontinue the CGM(At 6 months)
- Mean Time in Range Outcomes(At 1 month and 3 months)
- Mean Change in Self-efficacy at 3 Months(Baseline and 3 months)
研究者
Paulina Cruz Bravo
Assistant Professor of Medicine
Washington University School of Medicine