Continuous Glucose Monitoring for the Management of Hyperglycemia in Patients With Glioblastoma (NCT07091864) | Clinical Trial Compass
RecruitingNot Applicable
Continuous Glucose Monitoring for the Management of Hyperglycemia in Patients With Glioblastoma
United States116 participantsStarted 2025-07-29
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is using continuous glucose monitors to manage high blood sugar in glioblastoma patients — can you explain why controlling glucose levels might matter for my specific type of tumor, and whether my current blood sugar levels are a concern for my treatment?
2The primary thing this trial is measuring is whether patients are alive at 12 months — what does that tell us about where the researchers think glucose management fits into overall survival, and how does that compare to what standard glioblastoma treatment already offers me?
3Since this is listed as Phase NA, meaning it doesn't fit neatly into the traditional Phase 1, 2, or 3 framework, what does that mean for how much we already know about the safety and benefit of using a continuous glucose monitor in this context?
4Wearing a continuous glucose monitor means ongoing data collection and likely more frequent check-ins — given everything else involved in glioblastoma treatment like chemotherapy and radiation, is the added burden of this trial realistic for my situation right now?
5Are there patients with IDH-wildtype WHO Grade 4 glioma, like me, for whom you'd recommend focusing entirely on standard-of-care treatment first rather than adding a monitoring study like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.