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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-29

Study Completion Date

2027-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Glioblastoma, IDH-Wildtype WHO Grade 4 Glioma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

To reduce bias, all imaging and quality of life assessments will be interpreted by evaluators blinded to group assignment.

Study Groups

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Arm A (SOC, CGM)

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.

Group Type EXPERIMENTAL

Best Practice

Intervention Type OTHER

Receive SOC treatment

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood sample collection

Dietary Intervention

Intervention Type OTHER

Attend dietary counseling sessions

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Monitoring

Intervention Type OTHER

Undergo CGM

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Supportive Care

Intervention Type OTHER

Receive endocrinology-guided interventions

Arm B (SOC, intermittent glucose monitoring)

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.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Receive SOC treatment

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood sample collection

Glucose Measurement

Intervention Type OTHER

Undergo intermittent glucose monitoring

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Best Practice

Receive SOC treatment

Intervention Type OTHER

Biospecimen Collection

Undergo blood sample collection

Intervention Type PROCEDURE

Dietary Intervention

Attend dietary counseling sessions

Intervention Type OTHER

Glucose Measurement

Undergo intermittent glucose monitoring

Intervention Type OTHER

Magnetic Resonance Imaging

Undergo MRI

Intervention Type PROCEDURE

Monitoring

Undergo CGM

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Supportive Care

Receive endocrinology-guided interventions

Intervention Type OTHER

Other Intervention Names

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standard of care standard therapy Biological Sample Collection Biospecimen Collected Specimen Collection Dietary Modification intervention, dietary Nutrition Intervention Nutrition Interventions Nutritional Interventions GLUC Glucose Magnetic Resonance Magnetic Resonance Imaging (MRI) Magnetic resonance imaging (procedure) Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI MRI Scan MRIs NMR Imaging NMRI Nuclear Magnetic Resonance Imaging sMRI Structural MRI monitor Supportive Therapy Symptom Management Therapy, Supportive

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No