Continuous Glucose Monitoring for the Management of Hyperglycemia in Patients With Glioblastoma
NCT ID: NCT07091864
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
116 participants
INTERVENTIONAL
2025-07-29
2027-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Arm A (SOC, CGM)
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.
Best Practice
Receive SOC treatment
Biospecimen Collection
Undergo blood sample collection
Dietary Intervention
Attend dietary counseling sessions
Magnetic Resonance Imaging
Undergo MRI
Monitoring
Undergo CGM
Questionnaire Administration
Ancillary studies
Supportive Care
Receive endocrinology-guided interventions
Arm B (SOC, intermittent glucose monitoring)
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.
Best Practice
Receive SOC treatment
Biospecimen Collection
Undergo blood sample collection
Glucose Measurement
Undergo intermittent glucose monitoring
Magnetic Resonance Imaging
Undergo MRI
Questionnaire Administration
Ancillary studies
Interventions
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Best Practice
Receive SOC treatment
Biospecimen Collection
Undergo blood sample collection
Dietary Intervention
Attend dietary counseling sessions
Glucose Measurement
Undergo intermittent glucose monitoring
Magnetic Resonance Imaging
Undergo MRI
Monitoring
Undergo CGM
Questionnaire Administration
Ancillary studies
Supportive Care
Receive endocrinology-guided interventions
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Gelareh Zadeh, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Clinical Trials Referral Office
Role: primary
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2025-04735
Identifier Type: REGISTRY
Identifier Source: secondary_id
25-006112
Identifier Type: OTHER
Identifier Source: secondary_id
SING
Identifier Type: OTHER
Identifier Source: secondary_id
SING
Identifier Type: -
Identifier Source: org_study_id