Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07091864

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

Best Practice

Other

Receive SOC treatment

Other names: standard of care, standard therapy

Biospecimen Collection

Procedure

Undergo blood sample collection

Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Dietary Intervention

Other

Attend dietary counseling sessions

Other names: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions

Glucose Measurement

Other

Undergo intermittent glucose monitoring

Other names: GLUC, Glucose

Magnetic Resonance Imaging

Procedure

Undergo MRI

Other names: 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

monitoring

Other

Undergo CGM

Other names: monitor

Questionnaire Administration

Other

Ancillary studies

Supportive Care

Other

Receive endocrinology-guided interventions

Other names: Supportive Therapy, Symptom Management, Therapy, Supportive

Primary outcomes

  1. Overall survival at 12 months

    Time frame: At 12 months

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

Secondary outcomes

  1. Incidence of symptomatic hypoglycemia

    Time frame: Up to 52 weeks

    Will be defined as continuous glucose monitoring glucose < 70 mg/dL with concurrent symptoms. Proportion of participants with ≥ 1 symptomatic hypoglycemia event will be analyzed with Fisher's exact test.

  2. Quality of Life - EORTC QLQ C-30

    Time frame: At baseline, 3 months, 6 months, and 12 months

    The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 is a 30-item questionnaire where 28 questions are answered on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, and 4= very much) and 2 two questions are answered on a scale of 1-7 (1= very poor and 7=excellent). Higher summary scores indicate better health related quality of life.

  3. Quality of Life - EORTC QLQ-BN20

    Time frame: At baseline, 3 months, 6 months, and 12 months

    The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-BN20 is a 20-item questionnaire related to symptoms experienced by patients with brain cancer during the past week. Questions are answered on a scale of 1-4 where 1=not at all, 2=a little; 3-quite a bit; and 4=very much. Higher scores indicate greater severity of symptoms.

  4. Hemoglobin (HbA1c)

    Time frame: At 3 months, 6 months, and 12 months

    Compared at 3, 6 and 12 months using repeated measures mixed models. Model based contrasts will be used to estimate the between group changes from baseline in A1c values. Random intercept will be used.

  5. Fasting glucose

    Time frame: At 3 months, 6 months, and 12 months

    Compared at 3, 6 and 12 months using repeated measures mixed models. Random intercept will be used.

  6. Lactate levels (continuous)

    Time frame: At 3 months, 6 months, and 12 months

    Compared at 3, 6 and 12 months using repeated measures mixed models. Random intercept will be used.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Phase II Randomized Trial Of Glucose Monitoring In Glioblastoma

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 29, 2025
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.