Using a continuous glucose monitor to manage high blood sugar in glioblastoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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
* Negative serum pregnancy test within 7 days prior to registration for individuals of childbearing potential
* Karnofsky performance status (KPS) ≥ 70 at baseline
* Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L (performed within 14 days prior to registration)
* Platelet count ≥ 100 × 10\^9/L (performed within 14 days prior to registration)
* Hemoglobin ≥ 9 g/dL (performed within 14 days prior to registration)
* Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance ≥ 60 mL/min (performed within 14 days prior to registration)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (performed within 14 days prior to registration)
* Total bilirubin ≤ 1.5 × ULN (performed within 14 days prior to registration)
* Willingness and ability to comply with CGM device use and attend dietary counseling sessions as per standard of care

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 registration
* Documented history of type 1 diabetes mellitus

Where it's running

• Mayo Clinic in Rochester
  Rochester, Minnesota, United States Recruiting
• Mayo Clinic in Arizona
  Phoenix, Arizona, United States Not yet recruiting
• Mayo Clinic in Florida
  Jacksonville, Florida, United States Not yet 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.