CGM Use in Hospitalized Patients With Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Continuous Glucose Monitors (CGM) Accuracy - Mean Absolute Relative Difference (MARD)
研究概览
简要总结
The purpose of this study is to determine if patient's own Continuous Glucose Monitor (CGMs) worn in the non-ICU hospital setting have adequate accuracy for blood glucose monitoring when compared to point-of-care (POC) capillary glucose measurement, and to determine if alerts given by CGMs worn in the non-ICU hospital would prevent episodes of hyperglycemia and hypoglycemia.
详细描述
All patients admitted to the hospital in inpatient or observation status and having a Continuous Glucose Monitor (CGMs) attached will be screened and identified by providers and nurses. An order will be placed by providers to continue patient's home CGM use in the hospital. "CGM patient agreement" describing the hospital policy for use of CGMs will be provided to the patient for signature. Patients will be encouraged to continue to wear their CGMs in the hospital unless their presence interferes with patients' medical care. CGM presence will be recorded by nursing in patient chart under LDA (lines, drains, airway) section. Patients will be approached by the research staff and will be offered enrollment in the study. A research consent will be reviewed with patients and will be provided for signature. Patients will be asked to continue to use their home CGMs in the hospital. If CGM sensor will reach the end of life, patients have the option to place a new sensor and to follow manufacturer recommendations for calibration and setting. Patients are responsible to provide their own sensors, transmitters and readers during the hospitalization period. If it is determined that the current sensor will interfere with hospital medical and surgical care (MRI testing, procedure at the site), patients will be asked to remove the CGM sensor and transmitter. Patients will have the option to replace the sensor after the procedure if they so desire.
Patients will continue to monitor their glucose level via CGM. For flash sensors, patients will be asked to scan their sensor at least every 8 and as needed. CGMs that require calibration will be calibrated by the patients using hospital glucometer readings. .
Patients alerted by their CGM about low glucose levels or fast downward or upward trending will have to notify their nursing staff. A POC blood glucose check will be done by nursing staff to confirm the alert or the trend. Treatment decisions will be made based on POC readings.
During hospitalization patients will continue to have their blood glucose checked with POC glucometers per hospital policy.
Treatment of diabetes and the associated complications, dosing of insulin, change from PO to insulin treatment and back to PO medications during hospitalization or at discharge will be done by the admitting team with help from the inpatient Endocrinology Consultation Service.
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 with Type 1 or 2 Diabetes Mellitus,
- •Patients 18 years of age or older,
- •Patients admitted under medical or surgical services.
- •Patients treated with diet alone, insulin (SQ, insulin pump) or oral hypoglycemic medications.
- •Have their own Continuous Glucose Monitoring (CGM) monitor present on admission or able to be placed after admission.
排除标准
- •Individuals under 18 years of age.
- •COVID-19 infection.
- •Infection of the skin at the CGM site requiring removal of the sensor.
- •Patients with altered Mental Status.
- •Patients unable to scan their flash CGMs at least every 8 hours.
- •Inability to provide written consent.
- •Hospitalized for less than 24 hours.
研究组 & 干预措施
CGM Patients
Patients with diabetes mellitus admitted to the hospital and using a CGM will be encouraged to continue to use these devices in inpatient setting. The device alarms of high or low glucose levels will be communicated to the nursing staff.
干预措施: Continuous Glucose Monitor (CGM) (Device)
结局指标
主要结局
Continuous Glucose Monitors (CGM) Accuracy - Mean Absolute Relative Difference (MARD)
时间窗: From date of enrollment and until discharge from the hospital up to 30 days.
The absolute relative difference (ARD) was defined as the absolute difference between control - point of care (POC) glucose reading and the corresponding CGM reading divided by POC glucose reading and expressed as percentage. ARD was calculated as mean absolute relative difference (MARD) with standard deviation. MARD was calculated between matched pairs of POC (point of care) glucose readings and the closest CGM reading. MARD was summarized as mean (standard deviation) or median (range) for glucose readings \<70 mg/dl, 70-180 mg/dL, \>180 mg/dl, 181-250mg/dl, \>250 mg/dl respectively.
Continuous Glucose Monitors (CGM) Accuracy - Mean Absolute Relative Difference (MARD)
时间窗: From date of enrollment and until discharge from the hospital up to 30 days.
The absolute relative difference (ARD) was defined as the absolute difference between control - point of care (POC) glucose reading and the corresponding CGM reading divided by POC glucose reading and expressed as percentage. ARD was calculated as mean absolute relative difference (MARD) with standard deviation. MARD was calculated between matched pairs of POC (point of care) glucose readings and the closest CGM reading. MARD was summarized as mean (standard deviation) or median (range) for glucose readings \<70 mg/dl, 70-180 mg/dL, \>180 mg/dl, 181-250mg/dl, \>250 mg/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 Duration of Hypoglycemic Episodes(From date of enrollment and until discharge from the hospital up to 30 days.)
- CGM Recorded Hyperglycemic Episodes(From date of enrollment and until discharge from the hospital up to 30 days.)
- CGM Recorded Duration of Hyperglycemic Episodes(From date of enrollment and until discharge from the hospital up to 30 days.)
- Variation in Mean Absolute Relative Difference (MARD) in Relation to Pharmacological and Physiological Parameters(From date of enrollment and until discharge from the hospital up to 30 days.)
- In Hospital Mortality(From date of enrollment and until discharge from the hospital up to 30 days.)
- Hospitalization Length of Stay(From date of enrollment and until discharge from the hospital up to 30 days.)
- Mortality Rate at 30 Days(From date of enrollment up to 60 days.)
- Number of Re-hospitalization Events at the Same Institution Within 30 Days From the Discharge Date of the Preceding Admission.(From date of enrollment up to 60 days.)
- Hospitalization Length of Stay(From date of enrollment and until discharge from the hospital up to 30 days.)
- Mortality Rate at 30 Days(From date of enrollment up to 60 days.)
- Number of Re-hospitalization Events at the Same Institution Within 30 Days From the Discharge Date of the Preceding Admission.(From date of enrollment up to 60 days.)
- CGM Recorded Hypoglycemia Episodes(From date of enrollment and until discharge from the hospital up to 30 days.)
- CGM Recorded Duration of Hypoglycemic Episodes(From date of enrollment and until discharge from the hospital up to 30 days.)
- CGM Recorded Hyperglycemic Episodes(From date of enrollment and until discharge from the hospital up to 30 days.)
- CGM Recorded Duration of Hyperglycemic Episodes(From date of enrollment and until discharge from the hospital up to 30 days.)
- Variation in Mean Absolute Relative Difference (MARD) in Relation to Pharmacological and Physiological Parameters(From date of enrollment and until discharge from the hospital up to 30 days.)
- In Hospital Mortality(From date of enrollment and until discharge from the hospital up to 30 days.)
研究者
Adrian G. Dumitrascu
Principal Investigator
Mayo Clinic