Continuous Glucose Monitor Use for Mayo Clinic Advanced Care at Home Patients With Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Time in Range
研究概览
简要总结
The purpose of this study is to measure differences in diabetes control with the use of continuous glucose monitor (CGM) and diabetes education compared with standard of care for glucose monitoring (glucometer checks) and diabetes education in participants with diabetes mellitus receiving therapy with insulin and being admitted to Mayo Clinic Advanced Care at Home Program (ACH).
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
- •Patients who are admitted to Advanced Care at Home (ACH) Program and supposed to remain in ACH for at least 72 hours.
- •Patients with previous diagnosis of DM type 1 or type
- •Patients taking subcutaneous (SQ) insulin either via multidose injections or SQ insulin pump.
- •Capable of giving signed informed consent
排除标准
- •Actively treated for diabetes ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS).
- •Participants taking acetaminophen more than 4g per day or more than 1gm every 6 hours.
- •Participants with altered mental status.
- •Participants diagnosed with dementia.
- •Patients with suicidal ideations or experiencing suicidal behavior.
- •Patients with liver cirrhosis.
- •Patients with End Stage Renal Disease on dialysis bot hemodialysis or peritoneal dialysis.
- •Participants with allergy to medical grade adhesive or medical tape.
- •Participants taking hydroxyurea.
- •Participants who are pregnant, wanting to become pregnant, or nursing during study period.
- •Patients with a planned MRI within the following 10 days after admission to ACH.
- •Participants currently using continuous glucose monitor (CGM) to dose insulin or check glucose level.
- •Participants with diabetes mellitus (DM) treated with diet alone.
- •Participants with DM treated with oral hypoglycemic medications.
- •Participants with DM treated with one SQ insulin injection daily.
- •Participants enrolled in other studies addressing CGM use.
- •Participants physically or emotionally incapable of handling a cell phone with a smart display.
- •Participants with hearing impaired to a degree that they are not able to hear a smart phone alert or alarm.
- •Patients lacking WIFI or Cellular coverage needed to connect the monitoring cell phone to Internet network.
研究组 & 干预措施
Continuous Glucose Monitoring
Subjects admitted to the Advanced Care at Home program (home hospital) will have the continuous glucose monitor sensor placed for up to 10 days to monitor and dose insulin.
干预措施: Continuous Glucose Monitor Dexcom G6 PRO (Device)
Control Arm (Standard of Care)
Subjects admitted to the Advanced Care at Home program (home hospital) will continue with standard of care glucose monitoring (capillary glucose levels checked via glucometer), insulin dosing, and DM treatment during the 10 day period.
结局指标
主要结局
Time in Range
时间窗: 10 days
Percentage of time with continuous glucose monitor values within 70-180 mg/dl
Mean daily glucose
时间窗: 10 days
Mean daily glucose level (mg/dl)
次要结局
- Mean absolute relative difference (MARD) variation with Oxygen saturation.(10 days)
- Frequency of hypoglycemia episodes(10 days)
- Mean absolute relative difference (MARD) variation with Daily hemoglobin.(10 days)
- Mean absolute relative difference (MARD) variation with Arterial blood pressure(10 days)
- Mean absolute relative difference (MARD) variation with Glomerular filtration rate (GFR)(10 days)
- Percentage of subjects to continue use of continuous glucose monitor(40 days)
研究者
Adrian G. Dumitrascu
Principal Investigator
Mayo Clinic