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.
Study Type
OBSERVATIONAL
Enrollment
15
Patients will receive standard of care alpelisib
All patients will wear Abbott FreeStyle Libre 2 system to obtain CGM data (glucoses measured every minute for 14 days). CGM monitors will be placed at least 10 days prior to starting alpelisib and continue CGM for at least 3 months while taking alpelisib.
HealthPartners Cancer Research Center
Saint Louis Park, Minnesota, United States
Time to peak glucose level following the administration of alpelisib
Time (hr., min.) from taking alpelisib to the peak of the median glucose line of the standardize AGP/CGM report from day 21-28 after start of alpelisib. (calculated as- the average time to peak glucose on 7-day AGP profile minus avg time taking alpelisib). Primary outcome is time to peak glucose for all patients on alpelisib combined
Time frame: Up to 28 days after start of alpelisib
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