Continuous Glucose Monitoring for the Management of Hyperglycemia in Patients With Glioblastoma

Phase II Randomized Trial Of Glucose Monitoring In Glioblastoma

This clinical trial studies whether continuous glucose monitoring (CGM) can be used to help patients with glioblastoma manage their blood sugar (glucose) levels and improve survival. Glioblastoma is the most common malignant primary brain tumor in adults, with an average survival time of approximately 15-18 months despite therapy. Studies have shown that having a higher-than-normal amount of glucose in the blood (hyperglycemia) during radiation therapy is associated with poorer survival outcomes in glioblastoma patients. Hyperglycemia in glioblastoma patients is often driven by steroids that are commonly used during treatment. CGM uses a device that places a sensor under the skin that monitors glucose levels at regular intervals, providing real-time, or near real-time, glucose information. This can help to identify when a patient has changes in their glucose levels so they may receive necessary interventions or medications sooner. CGM may be an effective way for glioblastoma patients to manage their glucose levels, which may improve survival.

Inclusion Criteria:

• Presumed newly diagnosed GBM based on imaging findings consistent with GBM on brain MRI (e.g., heterogeneously enhancing mass with central necrosis and surrounding edema), as determined by the treating neuro-oncology team
• Age ≥ 18 years at the time of consent
• Negative serum pregnancy test within 7 days prior to registration for individuals of childbearing potential
• Karnofsky performance status (KPS) ≥ 70 at baseline
• Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L (performed within 14 days prior to registration)
• Platelet count ≥ 100 × 10^9/L (performed within 14 days prior to registration)
• Hemoglobin ≥ 9 g/dL (performed within 14 days prior to registration)
• Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance ≥ 60 mL/min (performed within 14 days prior to registration)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (performed within 14 days prior to registration)
• Total bilirubin ≤ 1.5 × ULN (performed within 14 days prior to registration)
• Willingness and ability to comply with CGM device use and attend dietary counseling sessions as per standard of care

Exclusion Criteria:

• Recurrent glioblastoma
• History of eating disorders (e.g., anorexia nervosa, bulimia) or substance use disorder within the past 12 months
• Any other uncontrolled or inadequately managed medical illness (e.g., unstable cardiovascular, hepatic, renal, or psychiatric condition) that, in the opinion of the investigator, would interfere with study participation or interpretation of results
• Concurrent diagnosis of another active malignancy requiring treatment
• Pregnancy or breastfeeding at the time of registration
• Documented history of type 1 diabetes mellitus