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

Mayo Clinic116 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

116

Conditions

Glioblastoma, IDH-Wildtype WHO Grade 4 Glioma

Best PracticeOTHER

Receive SOC treatment

Biospecimen CollectionPROCEDURE

Undergo blood sample collection

Dietary InterventionOTHER

Attend dietary counseling sessions

Glucose MeasurementOTHER

Undergo intermittent glucose monitoring

Magnetic Resonance ImagingPROCEDURE

Undergo MRI

MonitoringOTHER

Undergo CGM

Questionnaire AdministrationOTHER

Ancillary studies

Supportive CareOTHER

Receive endocrinology-guided interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Overall survival at 12 months

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

Time frame: At 12 months

Secondary Outcomes

Incidence of symptomatic hypoglycemia

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.

Time frame: Up to 52 weeks

Quality of Life - EORTC QLQ C-30

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.

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

Quality of Life - EORTC QLQ-BN20

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.

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

Hemoglobin (HbA1c)

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.

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

Fasting glucose

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

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

Lactate levels (continuous)

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

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts