Glucose Monitoring During Chemotherapy
Pilot Study of Glucose Monitoring to Determine Rates of Hyperglycemia During Chemotherapy for Early Stage Breast Cancer
1 other identifier
observational
22
1 country
1
Brief Summary
This is a research study to look at blood sugar changes during chemotherapy using a continuous blood sugar monitoring device. The device uses patches that attach to the skin on the back of the arm to measure blood sugar changes for the duration of the chemotherapy course. Each patch lasts for about 2-weeks. During chemotherapy visits, new patches will be placed and will be worn until the chemotherapy course is complete. Participants will be in this study for 6 months. Approximately 50 patients will be enrolled in this study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 31, 2019
CompletedFirst Submitted
Initial submission to the registry
July 13, 2020
CompletedFirst Posted
Study publicly available on registry
July 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 17, 2022
CompletedJanuary 10, 2025
January 1, 2025
2.8 years
July 13, 2020
January 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prevalence of hyperglycemia
assess the prevalence of HG, defined as the number of participants who have ≥1 glucose value of ≥140 mg/dL at any point during chemotherapy
24 weeks
Secondary Outcomes (2)
Prevalence of impaired glucose tolerance at baseline in nondiabetic patients.
Baseline
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Baseline, week 12, and week 24
Study Arms (1)
FreeStyle Libre sensor cohort
Patients with early stage breast cancer will have their blood glucose levels monitored by the Freestyle libre pro sensor.
Interventions
The device uses patches that attach to the skin on the back of the arm to measure blood sugar changes for the duration of the chemotherapy course.
Eligibility Criteria
Patients with early stage breast cancer.
You may qualify if:
- Age ≥18 years
- History of stage I-III breast cancer
- Patient scheduled to receive adjuvant or neoadjuvant chemotherapy
- Signed informed consent
You may not qualify if:
- Current treatment with insulin
- Current treatment with non-topical steroids, with the exception of steroid treatment as a supportive chemotherapy medication
- Inability to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Herbert Irving Pavilion
New York, New York, 10032, United States
Related Publications (1)
Ulene SR, Wang S, Cook JR, McAuley F, Wooster ME, Faheem KF, Varoli A, McGuinness JE, Vasan N, Trivedi MS, Crew KD, Harden E, Law C, Hershman DL, Accordino MK. Continuous glucose monitoring to characterize hyperglycemia during chemotherapy for early stage breast cancer. Breast Cancer Res Treat. 2025 Aug;212(3):511-519. doi: 10.1007/s10549-025-07745-z. Epub 2025 Jun 4.
PMID: 40468140DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Melissa Accordino, MD
Columbia University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor of medicine at CUMC
Study Record Dates
First Submitted
July 13, 2020
First Posted
July 16, 2020
Study Start
October 31, 2019
Primary Completion
August 1, 2022
Study Completion
August 17, 2022
Last Updated
January 10, 2025
Record last verified: 2025-01