Mayo Clinic in Florida
Jacksonville, Florida, 32224, United States
NCT Number: NCT04653454
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Jacksonville, Florida, 32224, United States
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.
Decisions about insulin dosing or other diabetes treatments will be made based on hospital glucometer readings, and not based on CGM readings alone.
Patients will be asked to give the research team "provider access" to their cloud CGM software, or to allow the team to download their CGM data prior to discharge if their reading devices do not automatically synchronize with the cloud software.
CGM data will be compared with POC glucometer readings obtained in the hospital at approximately the same time. 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. The accuracy of CGM for glucose measurement in the hospital will be calculated.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
CGM data will be downloaded prior to discharge and it will be compared with hospital glucometer readings taken at the same time.
Time frame: 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.
Time frame: From date of enrollment and until discharge from the hospital up to 30 days.
The incidence of hypoglycemic episodes
Time frame: From date of enrollment and until discharge from the hospital up to 30 days.
CGM recorded duration of hypoglycemic episodes
Time frame: From date of enrollment and until discharge from the hospital up to 30 days.
The incidence of hyperglycemic episodes
Time frame: From date of enrollment and until discharge from the hospital up to 30 days.
The duration of hyperglycemic episodes
Time frame: From date of enrollment and until discharge from the hospital up to 30 days.
The correlation between MARD point of care (POC) and Creatinine, Glomerular Filtration Rate (GFR), Bicarbonate, Hemoglobin (Hb), Mean Arterial Pressure (MAP), and Peripheral Oxygen Saturation (SpO2). The Spearman's rank correlation method was used to calculate the correlation coefficient.
Time frame: From date of enrollment and until discharge from the hospital up to 30 days.
Mortality during index hospitalization
Time frame: From date of enrollment and until discharge from the hospital up to 30 days.
Duration of hospital stay in hours
Time frame: From date of enrollment up to 60 days.
Mortality rate at 30 days post discharge from the hospital
Time frame: From date of enrollment up to 60 days.
Number of re-hospitalization events that occurred at the same institution within 30 days from the discharge date of the preceding admission.
Mayo Clinic
Other
CGM Use in Hospitalized Patients With Diabetes Mellitus
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