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.
1 other identifier
interventional
118
3 countries
6
Brief Summary
Cancer patients with known or newly diagnosed (i.e. iatrogenic) Diabetes Mellitus (DM) in Palliative/Supportive Care will be enrolled. Patients will be randomly assigned to one of two groups. Patients included in the first group will monitor glucose levels through Continuous Glucose Monitoring (CGM), using the FreeStyle Libre 2 (FSL2). The second group is represented by the usual standard way for blood glucose (BG) monitoring (lancing device for finger samples). An interim analysis is foreseen when the half of the expected events (hyperglycemic peaks) will be observed. In case the results of interim analysis show superiority of the CGM (FSL2) group patients of the second group will be switched.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2021
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2021
CompletedFirst Posted
Study publicly available on registry
June 28, 2021
CompletedStudy Start
First participant enrolled
June 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedJuly 22, 2021
July 1, 2021
1 year
June 18, 2021
July 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate CGM by using FSL2 in preventing severe hyperglycemia peaks
First severe hyperglycemic peak (\>250 mg/dL) observed during evaluation
From recruitment until last followup (8 weeks)
Study Arms (2)
Continuous Glucose Monitoring
EXPERIMENTALThe FreeStyle Libre 2 Flash Glucose Monitoring System (FSL2) is a CGM device with real time alarms capability indicated for the management of diabetes in persons aged 4 and older. The Sensor holds eight (8) hours of data at a time. In order to have a daily diary of the Glucose level the patients or family or HCP must read the sensor (with reader or app) at least every height (8) hours. Every day at least three (3) scans of the sensor should be performed using the reader or the Smartphone App, generally at wake up in the morning, in the afternoon and at the time to go to sleep. The alarm system will be activated, so that the Glucose level is over the cut off limit of 180 mmol/L or when it is lower than the cut-off limit of 80 mmol/L, the patient and/or the family members and/or the caregiver will check the Glucose level by scanning the reader/smartphone over the sensor.
Standard Care
ACTIVE COMPARATORThis arm will perform the usual standard routine for blood glucose monitoring in patients with insulin therapy, that is represented by at least three finger pricks/die according to the usual standards routine of each center. Different frequency of finger pricks glucose measurements could be performed on the basis of health care professional patient assessment of each patient's needs.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Aged \> or = 18 years
- Diagnosed with advanced oncological disease
- Known/newly diagnosed DM according to ADA criteria
- Need of a Insulin therapy and need of Glycemia Monitoring with at least three finger pricks/die
- Karnofsky Index \>= 30
- Provision of signed and dated informed consent form
You may not qualify if:
- Diagnosis of all types of Dementia
- Presence of severe psychiatric diseases/symptoms
- Kidney failure requiring dialysis
- Patients with implanted pacemaker
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Antea Foundationlead
- Abbott Diabetes Carecollaborator
Study Sites (6)
Palliative care Service - Sheba Medical Centre
Ramat Gan, Israel
Antea Foundation
Roma, 00135, Italy
Centro di Cure Palliative "Insieme nella Cura" - Policlinico Universitario - Campus Bio-Medico (Roma)
Roma, Italy
Unità Operativa Complessa di Oncologia Medica - Policlinico Univeristario Campus Bio-medico di Roma
Rome, Italy
Fondazione FARO
Torino, Italy
Hospiz im Park
Arlesheim, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2021
First Posted
June 28, 2021
Study Start
June 30, 2021
Primary Completion
June 30, 2022
Study Completion
June 30, 2022
Last Updated
July 22, 2021
Record last verified: 2021-07