Hospital Use of CGM (Continuous Glucose Monitor) in Post-operative Patients With Diabetes Mellitus at High Risk for Hypo and Hyperglycemia
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- CGM accuracy
研究概览
简要总结
The purposes of this study is to study if CGMs worn in the postoperative ICU or non-ICU hospital setting have adequate accuracy for blood glucose monitoring when compared to point-of-care (POC) capillary glucometers.
详细描述
Eligible patients will be approached by research staff either preoperatively or on the first 5 days post-surgery and offered to be enrolled. If agreed to participate, they will be fitted with a blinded CGM monitor (Dexcom G6 PRO) as soon as they are awake and alert after the surgery. They will continue to have their blood glucose check as usual in the ICU and on surgical floors with POC glucometers. On discharge, or at the end of the first CGM sensor life, the sensor will be removed and sensor data will be analyzed. CGM data will be compared with Point-of-Care blood glucose monitoring obtained in the hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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 with Type 1 or 2 Diabetes Mellitus.
- •Patients 18 years of age or older.
- •Admitted for deceased donor renal transplant surgery, pancreas transplant surgery, heart transplant surgery, liver transplant surgery and lung transplant surgery.
- •Anticipated minimum of 72h hospital stay.
- •Patients on insulin therapy (IV, SQ) post-surgery.
排除标准
- •Active COVID-19 infection.
- •Pregnant or lactating female.
- •Altered Mental Status at the time of sensor placement (sensor will be placed once mental status will improve).
- •Inability to provide informed consent.
- •Patients taking more than 4 g of acetaminophen in 24 hours or more than 1 gm every 6 hours.
- •Patients with skin lesions at the application site that may interfere with placement of the sensor.
- •Patients with known allergy to medical grade adhesive.
研究组 & 干预措施
CGM Patients
Subjects with diabetes mellitus or medication induced diabetes that have been admitted to the hospital after a surgery for organ transplantation or scheduled for organ transplant surgery will be fitted with a CGM monitor to monitor glucose levels during hospitalization
干预措施: Continuous Glucose Monitor (CGM) (Device)
结局指标
主要结局
CGM accuracy
时间窗: From date of enrollment and until discharge from the hospital up to 30 days.
Measured by the mean absolute relative difference (MARD), calculated between matched pairs of POC (point of care) glucose monitors and the closest CGM reading. MARD will be summarized as mean (standard deviation) or median (range) for glucose readings \<70g/dl, \>180g/dl, \>250g/dl respectively.
次要结局
- CGM recorded hypoglycemia episodes(From date of enrollment and until discharge from the hospital up to 30 days.)
- CGM recorded hyperglycemia episodes(From date of enrollment and until discharge from the hospital up to 30 days.)
研究者
Adrian G. Dumitrascu
Principal Investigator
Mayo Clinic