Using a continuous glucose monitor to manage high blood sugar in glioblastoma
Phase II Randomized Trial Of Glucose Monitoring In Glioblastoma
We will try continuous glucose monitors to help adults with newly diagnosed glioblastoma control high blood sugar during treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Phoenix, Arizona and 2 other locations) |
| Trial ID | NCT07091864 on ClinicalTrials.gov |
What this trial studies
Adults with presumed newly diagnosed glioblastoma who meet lab and performance criteria will wear a sensor that measures glucose continuously and receive dietary counseling and best-practice interventions when high glucose is detected. The study combines real-time glucose monitoring with glucose measurements, dietary adjustments, and collection of biospecimens and MRI data to track clinical status. The approach is designed to identify steroid-driven hyperglycemia early so clinicians can intervene sooner. Outcomes will include glucose control metrics and clinical outcomes such as treatment tolerance and survival.
Who should consider this trial
Good fit: Adults (≥18) with presumed newly diagnosed, IDH-wildtype WHO grade 4 glioma (glioblastoma), KPS ≥70, adequate blood counts and organ function, and willingness to use a CGM device and attend dietary counseling are ideal candidates.
Not a fit: Patients with recurrent glioblastoma, prior glioblastoma therapy beyond surgery or biopsy, recent eating disorders or substance use disorder, or those unable/unwilling to use a CGM are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, using continuous glucose monitoring could reduce episodes of hyperglycemia during therapy and may improve treatment tolerance and survival.
How similar studies have performed: Continuous glucose monitoring is well established in diabetes care, but using CGM specifically to improve outcomes in glioblastoma is relatively novel and has limited direct evidence linking CGM-guided control to better survival.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Phoenix, Arizona and 2 other locations
- Mayo Clinic in Arizona — Phoenix, Arizona, United States (Not_yet_recruiting)
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Not_yet_recruiting)
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Gelareh Zadeh, MD, PhD — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.