GLYPALCARE STUDY - Multicenter, Randomized Study for Evaluating Continuous Glucose Monitoring (CGM) by Using FreeStyle Libre 2 (FSL2) for Preventing Hyperglycemia/Hypoglycemia Crisis in Advanced Oncological Patients.

"FSL2 is an integrated continuous glucose monitoring (CGM) system that provides continuous glucose measurements every minute to provide glucose levels, trends and alerts. It is composed by a sensor and a reader. The Sensor, to apply on the back of the arm, continuously measures glucose concentration in interstitial fluid and has an 8-hour memory capacity. The Sensor is factory calibrated, does not require finger stick calibration and can be worn for up to 14 days.~The reader is a small handheld device that monitors glucose values in real-time to provide alerts and alarms which, when enabled, warn the user of Low Glucose, High Glucose or Signal Loss and prompt the user to scan the Sensor.~The FSL 2 System is CE mark, it is commercially available and in the current study it is being used in accordance with approved labeling. No modifications of FSL2 System have been performed for the utilization in the current study."

"The control group is represented by the usual standard way for blood glucose (BG) monitoring. The control group will use a lancing device for finger samples for collection of blood drop to be put in the test strips to be read in the Glucose meter. Lancing devices, lancets and test strips used in the comparison groups are CE marked and are used according to the user's instructions.~Monitoring and/or self-monitoring of blood glucose using glucose meters and test strips provides quantitative measurements of fingerstick blood glucose at a single point in time for patients and their healthcare providers to monitor the effectiveness of glycemic control and make more immediate treatment with the right dosage of insulin. The usual standard routine for blood glucose monitoring in patients with DM and with insulin therapy is represented by at least three finger pricks/die according to the usual standards routine of each center."