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
This trial does not accept healthy volunteersQualifiers
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
Negative serum pregnancy test within 7 days prior to registration for individuals of childbearing potential
Karnofsky performance status (KPS) ≥ 70 at baseline
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Best Practice
Other interventionReceive SOC treatment
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Dietary Intervention
Other interventionAttend dietary counseling sessions
Glucose Measurement
Other interventionUndergo intermittent glucose monitoring
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Monitoring
Other interventionUndergo CGM
Questionnaire Administration
Other interventionAncillary studies
Supportive Care
Other interventionReceive endocrinology-guided interventions
Treatment groups
116 Participants
are divided into 2 treatment groupsGroup A: Arm A (SOC, CGM)Experimental treatment 7 interventions
Group B: Arm B (SOC, intermittent glucose monitoring)Active comparator 5 interventions
Trial outcomes
Primary outcomes
1
Overall survival at 12 months
Defined as the time from study enrollment until death due to any cause.
Time frame
At 12 monthsSecondary outcomes
1
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 weeks2
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 months3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov