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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT07091864
Status
Recruiting
Apply to this trial

Conditions

  • Glioblastoma, IDH-Wildtype
  • WHO Grade 4 Glioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Best Practice — OTHER
    Receive SOC treatment
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Dietary Intervention — OTHER
    Attend dietary counseling sessions
  • Glucose Measurement — OTHER
    Undergo intermittent glucose monitoring
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Monitoring — OTHER
    Undergo CGM
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Supportive Care — OTHER
    Receive endocrinology-guided interventions

Study Details

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.

Key Dates

Start date
Jul 29, 2025
Status verified
May 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
116 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

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

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaPhoenixArizona85054
Clinical Trials Referral Office
[email protected]
855-776-0015
Yazmeen Nims
480-342-2906
Bernard Bendok, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in FloridaJacksonvilleFlorida32224
Clinical Trials Referral Office
[email protected]
855-776-0015
General Clinical Studies Unit
904-953-2255
Alfredo Quinones-Hinojisa, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Gelareh Zadeh, MD, PhD (PRINCIPAL_INVESTIGATOR)

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