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Utilizing Continuous Glucose Monitoring to Characterize and Manage Hyperglycemia in Patients Initiating Alpelisib - Trial NCT06083038

Access comprehensive clinical trial information for NCT06083038 through Pure Global AI's free database. This phase not specified trial is sponsored by HealthPartners Institute and is currently Recruiting. The study focuses on Metastatic Breast Cancer. Target enrollment is 15 participants.

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NCT06083038
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Trial Details
ClinicalTrials.gov โ€ข NCT06083038
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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

Study Focus

Metastatic Breast Cancer

Alpelisib

Observational

drug

Sponsor & Location

HealthPartners Institute

Saint Louis Park, United States of America

Timeline & Enrollment

N/A

Oct 05, 2023

Jun 01, 2025

15 participants

Primary Outcome

Time to peak glucose level following the administration of alpelisib

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.

ICD-10 Classifications

Malignant neoplasm of breast
Malignant neoplasm of breast
Malignant neoplasm: Breast, unspecified
Malignant neoplasm: Central portion of breast
Malignant neoplasm: Overlapping lesion of breast

Data Source

ClinicalTrials.gov

NCT06083038

Non-Device Trial