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

NCT06083038 | Completed FDA Drug FDA Device

• 1 other identifier: CBYL719A0US16T
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hyperglycemia; Glucose management; Alpelisib

Outcome Measures

Primary Outcomes (1)

• Time to peak glucose level following the administration of alpelisib

  Time (hr., min.) from taking alpelisib to the peak of the median glucose line of the standardize AGP/CGM report from day 21-28 after start of alpelisib. (calculated as- the average time to peak glucose on 7-day AGP profile minus avg time taking alpelisib). Primary outcome is time to peak glucose for all patients on alpelisib combined

  Up to 28 days after start of alpelisib

Study Arms (1)

Metastatic breast cancer starting alpelisib

Drug: Alpelisib; Device: FreeStyle Libre 2 Continuous Glucose Monitor

Interventions

Alpelisib DRUG

Patients will receive standard of care alpelisib

Metastatic breast cancer starting alpelisib

FreeStyle Libre 2 Continuous Glucose Monitor DEVICE

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.

Metastatic breast cancer starting alpelisib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects scheduled to receive standard of care alpelisib for treatment of metastatic breast cancer.

You may qualify if:

• Adults aged 18 or older with a diagnosis of metastatic breast cancer that are initiating treatment with alpelisib.
• Must be willing and able to comply with study visits and procedures.
• Must meet standard clinical criteria for utilization of alpelisib including hormone-receptor positive/HER2 negative cancer with the presence of a PIK3CA mutation.
• Oncologist plans to use alpelisib until progression of disease or unacceptable toxicity.
• Patients must receive cancer care during alpelisib treatment phase with a HealthPartners oncologist and be willing to see IDC/HealthPartners Diabetes Education for diabetes management.
• Must have a compatible smartphone, access to a compatible smartphone, or the ability to upload CGM reader from home or bring the reader in to a medical visit at least once a month for uploading, to allow for remote management of diabetes and data collection.
• Life expectancy of at least 3 months

You may not qualify if:

• Known history of serious allergy to skin-adhesive material or previous cutaneous reaction to a continuous glucose monitor.
• Known currently uncontrolled diabetes, defined as the most recent HbA1c over 10% or history of DKA within 6 months prior to enrollment.
• Concurrent use of high-dose vitamin C, defined as ≥ 1g of oral vitamin C daily, or intravenous Vitamin C infusions.
• Any other concurrent severe and/or uncontrolled medical condition that, in the opinion of the investigator, would cause unacceptable safety risk, compromise compliance with the protocol, or contraindicate participation in the study. One example being known requirement for high dose steroids at the time of possible enrollment into the study.

Sponsors & Collaborators

• HealthPartners Institute: lead

Study Sites (1)

HealthPartners Cancer Research Center

Saint Louis Park, Minnesota, 55426, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Hyperglycemia

Interventions

Alpelisib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 13, 2023
• Study Start: October 5, 2023
• Primary Completion: January 13, 2025
• Study Completion: April 21, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

US (1)