NCT06083038

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 15 (estimated)
• Sponsor: HealthPartners Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-10-05
• Primary completion: 2025-01-13
• Completion: 2026-03-01
• First posted: 2023-10-13
• Last updated: 2025-12-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study