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

Mayo Clinic

Status: Begins enrollment in 1 month

Conditions: WHO Grade 4 Glioma; Glioblastoma, IDH-Wildtype

Treatments: Procedure: Magnetic Resonance Imaging; Other: Monitoring; Other: Dietary Intervention; Other: Best Practice; Other: Questionnaire Administration; Procedure: Biospecimen Collection; Other: Supportive Care; Other: Glucose Measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT07091864

25-006112 (Other Identifier)

SING (Other Identifier)

NCI-2025-04735 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 116 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed newly diagnosed glioblastoma (World Health Organization [WHO] grade IV)
• IDH-wildtype status confirmed by molecular testing
• Age ≥ 18 years at the time of consent
• Karnofsky performance status (KPS) ≥ 70 at baseline
• Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L
• Platelet count ≥ 100 × 10^9/L
• Hemoglobin ≥ 9 g/dL
• Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance ≥ 60 mL/min
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN
• Total bilirubin ≤ 1.5 × ULN
• Willingness and ability to comply with CGM device use and attend dietary counseling sessions as part of the study protocol

Exclusion criteria

• Recurrent glioblastoma or prior therapy for glioblastoma beyond surgical resection or biopsy
• 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 enrollment
• Documented history of type 1 diabetes mellitus

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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116 participants in 2 patient groups

Arm A (SOC, CGM)

Experimental group

Description:

Patients receive SOC treatment plus CGM with endocrinology-guided interventions as needed and attend dietary counseling sessions once a month for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and MRI throughout the trial.

Treatment:

Other: Supportive Care

Other: Questionnaire Administration

Procedure: Biospecimen Collection

Other: Dietary Intervention

Other: Best Practice

Other: Monitoring

Procedure: Magnetic Resonance Imaging

Arm B (SOC, intermittent glucose monitoring)

Active Comparator group

Description:

Patients receive SOC treatment plus intermittent glucose monitoring as clinically indicated for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and MRI throughout the trial.

Treatment:

Other: Glucose Measurement

Other: Questionnaire Administration

Procedure: Biospecimen Collection

Other: Best Practice

Procedure: Magnetic Resonance Imaging