Effect of early intervention using continuous glucose monitoring (CGM; FreeStyle Libre 2) for prevention of hyperglycemic adverse events in patients receiving capivasertib

A Prospective Study of Early Intervention Using Continuous Glucose Monitoring to Prevent Hyperglycemic Adverse Events in Patients Receiving Capivasertib - Prevention of capivasertib-associated hyperglycemia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000060135

Enrollment

Registered

2025-12-22

Start date

2025-12-22

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hormone receptor positive, HER2 negative unresectable or recurrent breast cancer with PIK3CA, AKT1, or PTEN gene mutations that has progressed after endocrine therapy

Interventions

Application of the FreeStyle Libre 2 sensor

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Outpatients eligible for treatment with capivasertib Patients who are able to provide written informed consent of their own will Patients aged over 20 and less than 90 years at the time of consent female

Exclusion criteria

Exclusion criteria: Patients deemed inappropriate for participation by the attending physician

Design outcomes

Primary

Measure	Time frame
Hyperglycemic events detected by FreeStyle Libre 2 data	—

Secondary

Measure	Time frame
Additional FreeStyle Libre 2 data, including mean sensor glucose, standard deviation, GMI, coefficient of variation, TIR, TBR (levels 1 and 2), TAR (levels 1 and 2), alert frequency, blood glucose levels, and HbA1c.	—

Countries

Japan

Contacts

Public ContactHanako Nakajima

Kyoto Prefectural University of Medicine Department of Endocrinology and Metabolism, Graduate School of Medical Science

tabahana@koto.kpu-m.ac.jp075-251-5506

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026