Utilizing Continuous Glucose Monitoring to Characterize and Manage Hyperglycemia in Patients Initiating Alpelisib

Overseen By Grace Gilmore

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: HealthPartners Institute

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

15 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a prospective, descriptive, single site, observational study in subjects receiving alpelisib for treatment of metastatic breast cancer. The purpose of the study is to characterize the impact of alpelisib on glucose control in patients with breast cancer using continuous glucose monitoring to measure glucose levels throughout the day and night. Patients will follow a hyperglycemia prevention and management regimen aimed to diminish hyperglycemia known to occur in most oncology patients starting alpelisib. All patients will wear an Abbott FreeStyle Libre 2 system to obtain continuous glucose monitor (CGM) data (glucose measured every minute for 14 days). CGM will be placed at least 10 days prior to starting alpelisib and continue for at least 3 months while taking alpelisib.

Eligibility Criteria

Inclusion Criteria

You have an estimated survival time of at least three months.

You are an adult aged 18 or over diagnosed with metastatic breast cancer, and you are commencing treatment with alpelisib.

You are prepared to adhere to the necessary study visits and actions.

Treatment Details

Participant Groups

Group I: Metastatic breast cancer starting alpelisib Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

HealthPartners Institute

Lead Sponsor

Trials

196

Recruited

3,721,000+