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

NCT07091864 | Recruiting

• 3 other identifiers: SINGNCI-2025-0473525-006112
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glioblastoma, IDH-Wildtype; WHO Grade 4 Glioma

Outcome Measures

Primary Outcomes (1)

• Overall survival at 12 months

  Defined as the time from study enrollment until death due to any cause.

  At 12 months

Secondary Outcomes (6)

• Incidence of symptomatic hypoglycemia

  Up to 52 weeks

• Quality of Life - EORTC QLQ C-30

  At baseline, 3 months, 6 months, and 12 months

• Quality of Life - EORTC QLQ-BN20

  At baseline, 3 months, 6 months, and 12 months

• Hemoglobin (HbA1c)

  At 3 months, 6 months, and 12 months

• Fasting glucose

  At 3 months, 6 months, and 12 months

Study Arms (2)

Arm A (SOC, CGM)

EXPERIMENTAL

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.

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

Arm B (SOC, intermittent glucose monitoring)

ACTIVE COMPARATOR

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.

Other: Best Practice; Procedure: Biospecimen Collection; Other: Glucose Measurement; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Receive SOC treatment

Also known as: standard of care, standard therapy

Arm A (SOC, CGM); Arm B (SOC, intermittent glucose monitoring)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm A (SOC, CGM); Arm B (SOC, intermittent glucose monitoring)

Dietary Intervention OTHER

Attend dietary counseling sessions

Also known as: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions

Arm A (SOC, CGM)

Glucose Measurement OTHER

Undergo intermittent glucose monitoring

Also known as: GLUC, Glucose

Arm B (SOC, intermittent glucose monitoring)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: 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

Arm A (SOC, CGM); Arm B (SOC, intermittent glucose monitoring)

Monitoring OTHER

Undergo CGM

Also known as: monitor

Arm A (SOC, CGM)

Questionnaire Administration OTHER

Ancillary studies

Arm A (SOC, CGM); Arm B (SOC, intermittent glucose monitoring)

Supportive Care OTHER

Receive endocrinology-guided interventions

Also known as: Supportive Therapy, Symptom Management, Therapy, Supportive

Arm A (SOC, CGM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Glioblastoma

Interventions

Practice Guidelines as Topic; Standard of Care; Specimen Handling; Diet Therapy; Glucose; Magnetic Resonance Spectroscopy; Palliative Care

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Nutrition Therapy; Therapeutics; Hexoses; Monosaccharides; Sugars; Carbohydrates; Spectrum Analysis; Chemistry Techniques, Analytical; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Gelareh Zadeh, MD, PhD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: To reduce bias, all imaging and quality of life assessments will be interpreted by evaluators blinded to group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 29, 2025
• Study Start: July 29, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (1)