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Recruiting NCT07091864

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

No phase Interventional Glioblastoma, IDH-Wildtype WHO Grade 4 Glioma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Best Practice, Biospecimen Collection, Dietary Intervention, Glucose Measurement.
Who it may be relevant to
Registry conditions: Glioblastoma, IDH-Wildtype, WHO Grade 4 Glioma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Phase II Randomized Trial Of Glucose Monitoring In Glioblastoma

Overview

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.

Interventions

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

Primary outcome measures

  • Overall survival at 12 months [Time frame: At 12 months]
Secondary outcome measures (6)
  • Incidence of symptomatic hypoglycemia [Time frame: Up to 52 weeks]
  • Quality of Life - EORTC QLQ C-30 [Time frame: At baseline, 3 months, 6 months, and 12 months]
  • Quality of Life - EORTC QLQ-BN20 [Time frame: At baseline, 3 months, 6 months, and 12 months]
  • Hemoglobin (HbA1c) [Time frame: At 3 months, 6 months, and 12 months]
  • Fasting glucose [Time frame: At 3 months, 6 months, and 12 months]
  • Lactate levels (continuous) [Time frame: At 3 months, 6 months, and 12 months]

Eligibility criteria

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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

United States · 3 centers
  • Mayo Clinic in Arizona — Phoenix
  • Mayo Clinic in Florida — Jacksonville
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT07091864 · SING · 25-006112

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗