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NCT06083038Recruiting

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
HealthPartners InstituteClinicalTrials.govdrug
Study focus
Drug/Device/Intervention
Alpelisib
Study type
Observational
Intervention type
drug
Sponsor & location
Primary sponsor
HealthPartners Institute
Location
Saint Louis Park, United States of America
Timeline & enrollment
Phase
N/A
Start date
Oct 05, 2023
End date
Jun 01, 2025
Enrollment
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 breastMalignant neoplasm of breastMalignant neoplasm: Breast, unspecifiedMalignant neoplasm: Central portion of breastMalignant neoplasm: Overlapping lesion of breast
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06083038
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.