MedTrace Logo

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

NCT06083038 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 8

Last updated 2026-05-06

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • HealthPartners Institute

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-05
Primary Completion
2025-01-13
Completion
2026-04-21
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06083038 on ClinicalTrials.gov