Actively Recruiting
Phase II Randomized Trial of Continuous Glucose Monitoring Versus Intermittent Glucose Monitoring in Patients With Glioblastoma
Led by Mayo Clinic · Updated on 2026-05-07
116
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether continuous glucose monitoring (CGM) can help patients with glioblastoma manage their blood sugar levels and potentially improve survival. Glioblastoma is the most common malignant primary brain tumor in adults, with an average survival time of about 15 to 18 months despite treatment. High blood sugar during radiation therapy is linked to worse survival outcomes, often caused by steroids used in glioblastoma treatment. CGM uses a sensor placed under the skin to monitor glucose regularly, offering real-time information that may allow earlier interventions to manage glucose levels. Participants are randomly assigned to one of two groups: one group receives standard of care (SOC) treatment plus CGM with endocrinology-guided interventions and monthly dietary counseling for up to 52 weeks, while the other group receives SOC plus intermittent glucose monitoring as needed for up to 52 weeks. Both groups will undergo blood sample collection and MRI scans during the trial to monitor health and treatment effects. During the study, participants will attend regular visits for glucose monitoring, dietary counseling (if assigned), blood draws, and MRI scans. Researchers will assess overall survival at 12 months as the main outcome and monitor secondary outcomes such as symptomatic low blood sugar episodes, quality of life, hemoglobin A1c, fasting glucose, and lactate levels at various time points. The trial includes safety monitoring and will continue as long as there is no disease progression or unacceptable side effects, lasting up to 52 weeks per participant.
CONDITIONS
Brief Title
Continuous Glucose Monitoring for the Management of Hyperglycemia in Patients With Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Presumed newly diagnosed glioblastoma based on brain MRI consistent with GBM
- Age 18 years or older at time of consent
- Karnofsky performance status of 70 or higher at baseline
- Absolute neutrophil count greater than or equal to 1.5 x 10^9/L
- Platelet count greater than or equal to 100 x 10^9/L
- Hemoglobin level greater than or equal to 9 g/dL
- Serum creatinine less than or equal to 1.5 times the upper limit of normal or creatinine clearance at least 60 mL/min
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 times the upper limit of normal
- Total bilirubin less than or equal to 1.5 times the upper limit of normal
- Willing and able to comply with continuous glucose monitoring device use and attend dietary counseling sessions
You will not qualify if you...
- Recurrent glioblastoma or prior therapy for glioblastoma beyond surgery or biopsy
- History of eating disorders or substance use disorder within the past 12 months
- Uncontrolled or inadequately managed medical illness that would interfere with participation
- Active diagnosis of another cancer requiring treatment
- Pregnant or breastfeeding at enrollment
- History of type 1 diabetes mellitus
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 weeks in the absence of disease progression or unacceptable toxicity
Participants receive standard of care treatment combined with either continuous glucose monitoring and endocrinology-guided interventions plus monthly dietary counseling, or intermittent glucose monitoring as clinically indicated. Blood sample collections and MRI scans occur throughout the treatment period.
Monthly dietary counseling visits for up to 12 months; blood sample collections and MRI scans at multiple time points
Trial Site Locations
Total: 3 locations
1
Mayo Clinic in Arizona
Phoenix, Arizona, United States, 85054
Not Yet Recruiting
2
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Not Yet Recruiting
3
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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