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ACTIVE NOT RECRUITING
NCT06083038

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

Sponsor: HealthPartners Institute

View on ClinicalTrials.gov

Summary

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.

Official title: Utilizing Continuous Glucose Monitoring (CGM) to Characterize and Manage Hyperglycemia in Patients Initiating Alpelisib

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

15

Start Date

2023-10-05

Completion Date

2026-03

Last Updated

2025-12-31

Healthy Volunteers

Not specified

Interventions

DRUG

Alpelisib

Patients will receive standard of care alpelisib

DEVICE

FreeStyle Libre 2 Continuous Glucose Monitor

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.

Locations (1)

HealthPartners Cancer Research Center

Saint Louis Park, Minnesota, United States