116 Participants Needed

Continuous Glucose Monitoring for Brain Cancer

CT
Overseen ByClinical Trials Referral Office
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if continuous glucose monitoring (CGM) can help individuals with glioblastoma, a type of brain cancer, better manage their blood sugar levels. High blood sugar during treatment has been linked to worse outcomes, and CGM might help detect and manage these spikes early. The trial compares two groups: one using CGM with additional guidance and another using regular glucose checks. Suitable participants have been newly diagnosed with glioblastoma based on brain scans and can use the CGM device and attend dietary counseling. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve treatment outcomes for glioblastoma.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that continuous glucose monitoring is safe for glioblastoma patients?

Research shows that continuous glucose monitoring (CGM) helps people with diabetes track their blood sugar levels. Previous studies have demonstrated that this technology aids in more effective glucose management. CGM uses a small sensor placed under the skin to regularly check glucose levels.

Regarding safety, CGM is generally well-tolerated by people with diabetes, with few reports of serious side effects. Some users might experience minor skin irritation at the sensor site, but serious issues are rare.

This trial explores whether CGM can help patients with glioblastoma, a type of brain cancer, manage their blood sugar levels. Stabilizing these levels might improve survival rates for these patients.

While specific data on CGM use in brain cancer patients is lacking, its established use in diabetes suggests it is safe for many people. This trial seeks to determine if it can also benefit those with brain cancer.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential benefits of continuous glucose monitoring (CGM) for brain cancer patients, a method that hasn't been widely used in this context before. Unlike the standard intermittent glucose monitoring, CGM provides real-time data on glucose levels, allowing for more precise management and timely endocrinology-guided interventions. This could lead to better overall patient outcomes, as it offers a more comprehensive view of a patient's glucose trends and potential responses to treatment. Additionally, the incorporation of dietary counseling aims to further support patients by optimizing nutritional intake, which is a crucial aspect of cancer care.

What evidence suggests that continuous glucose monitoring is effective for managing glucose levels in glioblastoma patients?

Research has shown that maintaining blood sugar levels is crucial for glioblastoma patients. High blood sugar during treatment correlates with worse survival rates. Studies have found that continuous glucose monitoring (CGM) helps track blood sugar levels in real time, enabling quicker intervention if necessary. In this trial, some participants will receive standard of care (SOC) treatment plus CGM, potentially aiding in the detection and management of blood sugar spikes. A review of over 2,000 brain tumor patients confirmed that high blood sugar significantly reduces overall survival. By using CGM, glioblastoma patients might better control their blood sugar, potentially improving their survival chances.12367

Who Is on the Research Team?

GZ

Gelareh Zadeh, MD, PhD

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

This trial is for adults with glioblastoma, a type of brain cancer. It's focused on those who may have high blood sugar due to their treatment. Participants should be able to use a continuous glucose monitoring device and follow the study procedures.

Inclusion Criteria

My cancer does not have IDH mutations.
Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L
Platelet count ≥ 100 × 10^9/L
See 8 more

Exclusion Criteria

I have been diagnosed with type 1 diabetes.
Pregnancy or breastfeeding at the time of enrollment
I am being treated for another cancer besides the one being studied.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SOC treatment plus either continuous glucose monitoring (CGM) or intermittent glucose monitoring for up to 52 weeks

52 weeks
Monthly visits for dietary counseling and regular monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
Regular assessments at 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Continuous Glucose Monitoring
Trial Overview The study tests if using continuous glucose monitoring can help manage blood sugar levels in glioblastoma patients, potentially improving survival. It includes dietary interventions, regular MRI scans, biospecimen collection for research, and questionnaires about health.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (SOC, CGM)Experimental Treatment7 Interventions
Group II: Arm B (SOC, intermittent glucose monitoring)Active Control5 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Citations

Continuous Glucose Monitoring for Brain CancerThis clinical trial studies whether continuous glucose monitoring (CGM) can be used to help patients with glioblastoma manage their blood sugar (glucose) ...
Assessing the effectiveness of continuous glucose monitoring ...Exploratory outcomes are overall postoperative infection rate, MACE rate, brain damage (eg, delirium and stroke) and length of hospital stay ...
Rewiring of cortical glucose metabolism fuels human brain ...How brain cancers rewire glucose use to drive aggressive growth remains unclear. Here we infused 13C-labelled glucose into patients and mice ...
Metabolic imbalance and brain tumors: The interlinking ...A meta-analysis encompassing 7 studies with > 2000 brain tumor patients confirmed this link, showing that hyperglycemia significantly reduces overall survival [ ...
Continuous Glucose Monitoring for the Management of ...This clinical trial studies whether continuous glucose monitoring (CGM) can be used to help patients with glioblastoma manage their blood sugar (glucose) ...
USE OF A CONTINUOUS GLUCOSE MONITOR FOR ...We describe a case of a 55-year-old female with hypoglycemia unawareness and seizures diagnosed with proinsulinoma. She utilized an intermittently scanned ...
Impact of glycemia on survival of glioblastoma patients ...This study demonstrates and validates that glycemia is an independent predictor for survival in GB patients treated with RT and TMZ.
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