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Continuous Glucose Monitoring for the Management of Hyperglycemia in Patients With Glioblastoma | Clinical Trials | Clareo Health

RECRUITINGNA

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

Phase II Randomized Trial Of Glucose Monitoring In Glioblastoma

NCT07091864•Mayo Clinic

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
•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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Key Dates

Start Date

July 29, 2025

Primary Completion Date

November 30, 2027

Completion Date

November 30, 2027

Last Updated

November 10, 2025

Enrollment

116

ESTIMATED participants

Conditions

Glioblastoma, IDH-WildtypeWHO Grade 4 Glioma

Interventions

Best Practice

OTHER

Biospecimen Collection

PROCEDURE

Dietary Intervention

OTHER

Glucose Measurement

OTHER

Magnetic Resonance Imaging

PROCEDURE

Monitoring

OTHER

Questionnaire Administration

OTHER

Supportive Care

OTHER

Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015 mayocliniccancerstudies@mayo.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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