US Cllinic is about to start clinical trial of Continuous Glucose Monitoring in Hospitalized Patients With Diabetes Mellitus
Mayo Clinic is starting a new clinical trial of Continuous Glucose Monitoring in Hospitalized Patients With Diabetes Mellitus.
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.
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.
Decisions about insulin dosing or other diabetes treatments will be made based on hospital glucometer readings, and not based on CGM readings alone.
Among the criteria that do not allow participation, the following are indicated:
- 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.
The clinical trial starts on January 1, 2021 and will continue throughout December 31, 2021.
The contacts and locations are the Mayo Clinic in Florida, Jacksonville, Florida, United States. For more details: https://ichgcp.net/clinical-trials-registry/NCT04653454
