GLYcemic Control Evaluation by Continuous Glucose Monitor Compared With a1C in Left Ventricular Assist Device-supported Patients (GLYCEM1C-LVAD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Average glucose values based on continuous glucose monitoring
研究概览
简要总结
The study is being conducted to understand if the hemoglobin A1c, a measurement of control of blood sugars over a 3-month time, is valid in patients with Left Ventricular Assist Devices (LVADs) in place. To understand whether it is an adequate measurement, the investigators will compare the A1c to results from a continuous glucose monitor (CGM) measurement of blood sugars. By monitoring blood sugars continuously, the investigators will also assess whether they can get better control of blood sugars with a CGM, including avoiding low blood sugars.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Prior implantation of contemporary, centrifugal flow LVAD (HeartWare or HeartMate 3) at any time after 2010
- •Diagnosis of type II diabetes mellitus
- •Any antihyperglycemic regimen
- •Greater than 3 months out from LVAD implantation
- •Capable of utilizing smartphone device for LibreLink app for uploading glycemic data
- •Patients may be enrolled who have preexisting CGM in place.
排除标准
- •Type I diabetics
- •Unable to return at 3 month evaluation
- •Unwillingness to participate
研究组 & 干预措施
Left Ventricular Assist Device (LVAD) supported Type 2 Diabetes Mellitus (T2DM) Subjects
Subjects diagnosed with T2DM who have a LVAD will be provided a Freestyle Libre 3 CGM.
干预措施: Freestyle Libre 3 Continuous Glucose Monitor (CGM) (Device)
结局指标
主要结局
Average glucose values based on continuous glucose monitoring
时间窗: 3 months
Average level of blood sugar reported in mg/dL obtained via the Freestyle Libre 3 CGM over a 3 month period.
Estimated average glucose (eAG) values based on fructosamine lab values
时间窗: 3 months
Estimated average level of blood sugar reported in mg/dL based on conversion of fructosamine lab values (eAG= 28.7\*(0.017 x fructosamine + 1.61) - 46.7) collected at the 3-month visit.
Estimated average glucose (eAG) values based on hemoglobin-A1c lab values
时间窗: 3 months
Estimated average level of blood sugar reported in mg/dL based on conversion of hemoglobin-A1c lab values (eAG=28.7\*A1C - 46.7) collected at the 3-month visit.
次要结局
- Number of hypoglycemic unawareness episodes(3 months)
- Number of adjustments of antihyperglycemic agents(3 months)
研究者
Andrew N Rosenbaum
Principal Investigator
Mayo Clinic