Glioblastoma, IDH-WildtypeNCT07091864
Continuous Glucose Monitoring for the Management of Hyperglycemia in Patients With Glioblastoma
A study testing Best Practice, Biospecimen Collection and Dietary Intervention in people with Glioblastoma, IDH-Wildtype and WHO Grade 4 Glioma, run by Mayo Clinic at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, IDH-Wildtype, WHO Grade 4 Glioma
- What is being tested?
- Best Practice, Biospecimen Collection and Dietary Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Jul 2025to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
General Clinical Studies Unit, 904-953-2255
- Not yet recruiting
Mayo Clinic in Arizona
Phoenix, Arizona, 85054
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Yazmeen Nims, 480-342-2906
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Gelareh Zadeh, MD, PhD
About this study
Official title: Phase II Randomized Trial Of Glucose Monitoring In Glioblastoma
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
- Glioblastoma, IDH-Wildtype, WHO Grade 4 Glioma
- Being tested
- Best Practice, Biospecimen Collection, Dietary Intervention, Glucose Measurement, Magnetic Resonance Imaging
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive SOC treatment
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Dietary InterventionOther
Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions
Attend dietary counseling sessions
Glucose MeasurementOther
Also called GLUC, Glucose
Undergo intermittent glucose monitoring
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
MonitoringOther
Also called monitor
Undergo CGM
Questionnaire AdministrationOther
Ancillary studies
Supportive CareOther
Also called Supportive Therapy, Symptom Management, Therapy, Supportive
Receive endocrinology-guided interventions
| Study group | Role | What they receive |
|---|---|---|
| Arm A (SOC, CGM) | Experimental | 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. Receives: Other: Best Practice; Procedure: Biospecimen Collection; Other: Dietary Intervention; Procedure: Magnetic Resonance Imaging; Other: Monitoring; Other: Questionnaire Administration; Other: Supportive Care |
| Arm B (SOC, intermittent glucose monitoring) | Active comparator | 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. Receives: Other: Best Practice; Procedure: Biospecimen Collection; Other: Glucose Measurement; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival at 12 months
Defined as the time from study enrollment until death due to any cause.
Measured: At 12 months
Secondary outcomes (6)
Incidence of symptomatic hypoglycemia
Will be defined as continuous glucose monitoring glucose < 70 mg/dL with concurrent symptoms. Proportion of participants with ≥ 1 symptomatic hypoglycemia event will be analyzed with Fisher's exact test.
Measured: Up to 52 weeks
Quality of Life - EORTC QLQ C-30
The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 is a 30-item questionnaire where 28 questions are answered on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, and 4= very much) and 2 two questions are answered on a scale of 1-7 (1= very poor and 7=excellent). Higher summary scores indicate better health related quality of life.
Measured: At baseline, 3 months, 6 months, and 12 months
Quality of Life - EORTC QLQ-BN20
The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-BN20 is a 20-item questionnaire related to symptoms experienced by patients with brain cancer during the past week. Questions are answered on a scale of 1-4 where 1=not at all, 2=a little; 3-quite a bit; and 4=very much. Higher scores indicate greater severity of symptoms.
Measured: At baseline, 3 months, 6 months, and 12 months
Hemoglobin (HbA1c)
Compared at 3, 6 and 12 months using repeated measures mixed models. Model based contrasts will be used to estimate the between group changes from baseline in A1c values. Random intercept will be used.
Measured: At 3 months, 6 months, and 12 months
Fasting glucose
Compared at 3, 6 and 12 months using repeated measures mixed models. Random intercept will be used.
Measured: At 3 months, 6 months, and 12 months
Lactate levels (continuous)
Compared at 3, 6 and 12 months using repeated measures mixed models. Random intercept will be used.
Measured: At 3 months, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start29 Jul 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma, IDH-WildtypeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gelareh Zadeh, MD, PhD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091864
- Sponsor's protocol ID
- SING
- Other IDs
- 25-006112
- Status last verified
- Aug 2026
- First submitted
- 21 Jul 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Trial Of Glucose Monitoring In Glioblastoma
- ClinicalTrials.gov ID
- NCT07091864
- Acronym / sponsor ID
- SING
- Conditions
- Glioblastoma, IDH-Wildtype, WHO Grade 4 Glioma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 29 Jul 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (SOC, CGM) | Experimental | Other: Best Practice, Procedure: Biospecimen Collection, Other: Dietary Intervention, Procedure: Magnetic Resonance Imaging, Other: Monitoring, Other: Questionnaire Administration, Other: Supportive CarePatients 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. |
| Arm B (SOC, intermittent glucose monitoring) | Active comparator | Other: Best Practice, Procedure: Biospecimen Collection, Other: Glucose Measurement, Procedure: Magnetic Resonance Imaging, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive SOC treatment | Other | Arm A (SOC, CGM), Arm B (SOC, intermittent glucose monitoring) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Arm A (SOC, CGM), Arm B (SOC, intermittent glucose monitoring) |
| Dietary InterventionAlso: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition InterventionsAttend dietary counseling sessions | Other | Arm A (SOC, CGM) |
| Glucose MeasurementAlso: GLUC, GlucoseUndergo intermittent glucose monitoring | Other | Arm B (SOC, intermittent glucose monitoring) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging ScanUndergo MRI | Procedure or surgery | Arm A (SOC, CGM), Arm B (SOC, intermittent glucose monitoring) |
| MonitoringAlso: monitorUndergo CGM | Other | Arm A (SOC, CGM) |
| Questionnaire AdministrationAncillary studies | Other | Arm A (SOC, CGM), Arm B (SOC, intermittent glucose monitoring) |
| Supportive CareAlso: Supportive Therapy, Symptom Management, Therapy, SupportiveReceive endocrinology-guided interventions | Other | Arm A (SOC, CGM) |
Primary outcome
Overall survival at 12 months
Time frame: At 12 months
Defined as the time from study enrollment until death due to any cause.
6 secondary outcomes
Incidence of symptomatic hypoglycemia
Time frame: Up to 52 weeks
Quality of Life - EORTC QLQ C-30
Time frame: At baseline, 3 months, 6 months, and 12 months
Quality of Life - EORTC QLQ-BN20
Time frame: At baseline, 3 months, 6 months, and 12 months
Hemoglobin (HbA1c)
Time frame: At 3 months, 6 months, and 12 months
Fasting glucose
Time frame: At 3 months, 6 months, and 12 months
Lactate levels (continuous)
Time frame: At 3 months, 6 months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gelareh Zadeh, MD, PhD principal investigator
Mayo Clinic in Rochester
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Biospecimen Collection and Dietary Intervention in people with Glioblastoma, IDH-Wildtype and WHO Grade 4 Glioma, run by Mayo Clinic at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival at 12 months (time frame: At 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.