Recruiting

CGM

Sponsor:

Mayo Clinic

Code:

NCT07091864

Conditions

Glioblastoma, IDH-Wildtype

WHO Grade 4 Glioma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Best Practice

Biospecimen Collection

Dietary Intervention

Glucose Measurement

Magnetic Resonance Imaging

Study Details

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

Study ID

NCT07091864

Start date

Jul 29, 2025

Status verified date

Aug, 2026

Completion date

Nov 30, 2027

Anticipated

Primary completion date

Nov 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

116 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

Interventions

Best Practice

Receive SOC treatment

Biospecimen Collection

Undergo blood sample collection

Dietary Intervention

Attend dietary counseling sessions

Glucose Measurement

Undergo intermittent glucose monitoring

Magnetic Resonance Imaging

Undergo MRI

Monitoring

Undergo CGM

Questionnaire Administration

Ancillary studies

Supportive Care

Receive endocrinology-guided interventions

Primary outcome measure

  • Overall survival at 12 months [ Time Frame: At 12 months ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Gelareh Zadeh, MD, PhD

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-17.