Continuous Glucose Monitor (CGM) Use in COVID-19 Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Mean Absolute Relative Difference (MARD)
研究概览
简要总结
The purpose of this research is to determine if CGM (continuous glucose monitors) used in the hospital in patients with COVID-19 and diabetes treated with insulin will be as accurate as point of care (POC) glucose monitors. Also if found to be accurate, CGM reading data will be used together with POC glucometers to dose insulin therapy.
详细描述
Study participation involves placement of a continuous glucose monitor (CGM) on the abdomen of hospitalized patients who have a diagnosis of COVID19. The CGM will measure glucose levels every 5 minutes which will be accessible for viewing using a receiver phone placed outside the patient's room and/or an iPad located at the nursing station.
Alarm limits for hypoglycemia and hyperglycemia will be set on the receiver phone for nursing staff to review. These alarms settings will vary depending on whether the patient is on IV insulin infusion vs. subcutaneous (SQ) insulin. The number of glucose checks required with these two types of insulin varies significantly and requires separate handling.
Hospital glucometers will be used to confirm the accuracy of CGM readings during an initial "Adjustment Phase" of the study. If CGMs are found to be accurate, then finger-stick glucometer check frequency will be decreased, and some of the CGM values will be used to dose insulin therapy during the "Utilization Phase" of the study. The instructions for these phases will differ for patients on IV insulin infusion vs. SQ insulin infusion and are detailed in separate protocols. Nursing staff will choose the appropriate protocol at the time of CGM placement based on the type of insulin the patient is receiving.
Different patient variables (demographics, comorbidities, labs and vitals, administered medications) will be collected from electronic health record and will be evaluated to determine if they interfere with CGM readings. At the time of discharge, patients will receive a survey regarding satisfaction with the use of CGM monitors to manage their diabetes during their inpatient stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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 18 years or older.
- •Patients with diagnosis of COVID-19 respiratory infection.
- •Patient with recent positive SARS-COV2 infection and still positive polymerase chain reaction (PCR) admitted of non-respiratory diagnoses.
- •Diagnosis of diabetes mellitus type 1 or type
- •Diagnosis of medication (steroid) induced hyperglycemia (persistent glucose more than 180 mg/dl).
- •Taking insulin either SQ or IV.
排除标准
- •Patient in shock.
- •Patient intubated on mechanical ventilation.
- •Patient placed on Extracorporeal membrane oxygenation (ECMO).
- •Patient taking hydroxyurea.
- •Patient taking more than 4g of acetaminophen in 24 hours or more than 1g acetaminophen in 6 hours.
- •Pregnant or nursing female patients.
- •Patients with skin lesions at the application site that may interfere with placement of the sensor.
- •Patients with known allergy to medical grade adhesive.
结局指标
主要结局
Mean Absolute Relative Difference (MARD)
时间窗: From date of enrollment and until discharge from the hospital up to 30 days.
Per patient, the absolute relative difference is calculated as the absolute difference between Point of Care (POC) glucose measurements and the nearest Continuous glucose monitor (CGM) measurement (within 5 minutes of POC), divided by the POC glucose value and expressed as a percentage.
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.)
- Blood Oxygen Level (SpO2)(From date of enrollment and until discharge from the hospital up to 30 days.)
- Hospitalization Length of Stay(subject hospital discharge, up to approximately 3 months)
- Patient Satisfaction Using the Patient Satisfaction Survey(From date of admission and until discharge from the hospital up to 30 days.)
- Continuous Glucose Monitor (CGM) Calibrations(From date of enrollment and until discharge from the hospital up to 30 days.)
- Mean Arterial Pressure (MAP)(From date of enrollment and until discharge from the hospital up to 30 days.)
- Sensor Related Skin Reactions(From date of enrollment and until discharge from the hospital up to 30 days.)
- CGM Accuracy in Lactic Acidosis.(From date of enrollment and until discharge from the hospital up to 30 days.)
研究者
Adrian G. Dumitrascu
Principal Investigator
Mayo Clinic