Piqray CGM IIT: Utilizing Continuous Glucose Monitoring to Characterize and Manage Hyperglycemia in Patients Initiating Alpelisib (CBYL719A0US16T)
Principal Investigator: Dylan Zylla, MD, Richard Bergenstal, MD
Study sponsor: HealthPartners Institute
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: II
Purpose of study: The purpose of the study is to characterize and understand the impact of alpelisib on glucose control in patients with breast cancer using Continuous Glucose Monitoring (CGM) and following a hyperglycemia prevention and management regimen.
Inclusion Criteria:
– Adults age 18+ with diagnosis of metastatic Breast cancer that are initiating treatment with Alpelisib.
– Must be willing to and comply with study visits and procedures.
– Must meet standard clinical criteria for utilizing Alpelisib, including Hormone-receptor positive/HER2 negative cancer with presence of PIK3CA mutation.
– Treating oncologist must plan to use Alpelisib until disease progression or unacceptable toxicity.
– Patient must receive cancer care with a HealthPartners Oncologist during Alpelisib treatment phase and must be willing to see IDC/HealthPartners Diabetes Education for diabetes management.
– Must have compatible smartphone, access to compatible smartphone, or ability to digitally upload information from Continuous Glucose Monitor (CGM), or to bring the reader in to the medical visit at least once a month for uploading data.
– Must have life expectancy of at least 3 months.
Exclusion Criteria:
– Has known history or allergy to skin-adhesive material, or previous cutaneous reaction to a continuous glucose monitor.
– Known currently uncontrolled diabetes, defined as most recent HbA1c over 10%, or history of DKA within 6 months prior to enrollment.
– Concurrent use of high-dose vitamin C, defined as more than 1g of oral vitamin C daily, or IV vitamin C infusions.
– Any concurrent severe, or uncontrolled condition that, in the opinion of the investigator, would cause safety risk, compromise protocol compliance, or contraindicate patient’s participation in the study.
Study Contact:
Alissa Gavenda, RN
(952) 992-5705
[email protected]