Clinical trial · Interventional
Continuous Glucose Monitoring for the Management of Hyperglycemia in Patients With Glioblastoma
Phase II Randomized Trial Of Glucose Monitoring In Glioblastoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma, IDH-Wildtype | Glioblastoma, IDH-Wildtype | ONTOLOGY_EXACT | 0.90 |
| WHO Grade 4 Glioma | WHO Grade 4 Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Practice | Other | — | UNRESOLVED |
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Dietary Intervention | Other | — | UNRESOLVED |
| Glucose Measurement | Other | — | UNRESOLVED |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Monitoring | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Supportive Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A (SOC, CGM)
- description
- Patients receive SOC treatment plus CGM with endocrinology-guided interventions as needed and attend dietary counseling sessions once a month for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and MRI throughout the trial.
- interventionNames
- Other: Best Practice
- Procedure: Biospecimen Collection
- Other: Dietary Intervention
- Procedure: Magnetic Resonance Imaging
- Other: Monitoring
- Other: Questionnaire Administration
- Other: Supportive Care
- type
- ACTIVE_COMPARATOR
- label
- Arm B (SOC, intermittent glucose monitoring)
- description
- Patients receive SOC treatment plus intermittent glucose monitoring as clinically indicated for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and MRI throughout the trial.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available