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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Best Practice
  • Biospecimen Collection
  • Dietary Intervention
  • Glucose Measurement
  • Magnetic Resonance Imaging
  • Monitoring
  • Questionnaire Administration
  • Supportive Care

Treatment groups

116 Participants
are divided into 2 treatment groups

Locations

3
Mayo Clinic in Arizona85054, PhoenixArizona, United States
Mayo Clinic in Florida32224, JacksonvilleFlorida, United States
Mayo Clinic in Rochester55905, RochesterMinnesota, United States

Sponsors and collaborators

Mayo Clinic

Lead sponsor