Clinical trial · Interventional
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.
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 With Known/Newly Diagnosed Type I/Type II Diabetes Mellitus (DM) in Palliative Care/ Supportive Care (PC/SC) Setting.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Diabetes | — | UNRESOLVED | — |
| Diabetes Mellitus, Type 1 | — | UNRESOLVED | — |
| Diabetes Mellitus, Type 2 | — | UNRESOLVED | — |
| End Stage Cancer | — | UNRESOLVED | — |
| Palliative Care | — | UNRESOLVED | — |
| Terminal Cancer | — | UNRESOLVED | — |
| Terminal Illness | — | UNRESOLVED |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Continuous Glucose Monitoring | Device | — | UNRESOLVED |
| Standard Care | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Continuous Glucose Monitoring
- description
- The 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.
- interventionNames
- Device: Continuous Glucose Monitoring
- type
- ACTIVE_COMPARATOR
- label
- Standard Care
- description
- This 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion criteria: * Diagnosis of all types of Dementia * Presence of severe psychiatric diseases/symptoms * Kidney failure requiring dialysis * Patients with implanted pacemaker
References
Publications (0)
Data not yet available