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Glucose Monitoring to Predict and Treat High Glucose Levels After Steroid Treatment

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04210128
Collaborator
(none)
50
Enrollment
1
Location
59.4
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to see if continuous glucose monitoring can identify how often people who have pre-diabetes or medical obesity or well-controlled diabetes experience very high glucose values while receiving chemotherapy for breast cancer or pancreatic.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Continuous Glucose Monitoring For Prediction and Treatment of Steroid-Induced Hyperglycemia
    Actual Study Start Date :
    Dec 20, 2019
    Anticipated Primary Completion Date :
    Dec 1, 2024
    Anticipated Study Completion Date :
    Dec 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Breast cancer patients

    A blinded continuous glucose monitor (specifically a Freestyle Libre Pro) will be worn for a 14 day period by patients during the first and third cycles of breast neoadjuvant chemotherapy. At the end of that period (after completion of the one round of chemotherapy) readings will be downloaded from the sensor and the sensor will be removed. Readings will be evaluated by the treating endocrinologist as well as the study team and appropriate clinical interventions.
    Pancreatic cancer patients

    A blinded continuous glucose monitor (specifically a Freestyle Libre Pro) will be worn for a 14 day period by patients during the first and third cycles of pancreatic chemotherapy. At the end of that period (after completion of the one round of chemotherapy) readings will be downloaded from the sensor and the sensor will be removed. Readings will be evaluated by the treating endocrinologist as well as the study team and appropriate clinical interventions.

    Outcome Measures

    Primary Outcome Measures

    1. severe hyperglycemia [1 year]

      glucose > 400 mg/dL for over 3 contiguous hours

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patient aged 18 or older undergoing neoadjuvant chemotherapy regimens including taxane and/or anthracycline for breast cancer.

    • Patient aged 18 or older undergoing any chemotherapy regimen for pancreatic cancer

    • Have 'high metabolic risk(either pre-diabetes, obesity, or well-controlled diabetes) defined as either:

    • Pre-diabetes and/or obesity group: one or more of known HbA1c 5.7-6.5%, fasting glucose > 100 mg/dL, or BMI > 30

    • Well-controlled diabetes: Known HbA1c < 7.5 on lifestyle alone or up to one oral antidiabetic agent

    • Any patient undergoing treatment for pancreatic adenocarcinoma on either no antidiabetic agent or up to one oral antidiabetic agent

    Exclusion Criteria:

    • Patients with type 1 diabetes, a history of hospitalization for either hyperglycemia or ketoacidosis, a history of hypoglycemia requiring hospitalization, rashes or other skin reactions that would preclude placement of the CGM

    • Use of anticoagulants or antiplatelet agents other than aspirin

    • Platelet count < 50 K/μL within 60 days prior to enrollment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Memorial Sloan Kettering Cancer Center New York New York United States 10065

    Sponsors and Collaborators

    • Memorial Sloan Kettering Cancer Center

    Investigators

    • Principal Investigator: James Flory, MD, Memorial Sloan Kettering Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Memorial Sloan Kettering Cancer Center
    ClinicalTrials.gov Identifier:
    NCT04210128
    Other Study ID Numbers:
    • 19-315
    First Posted:
    Dec 24, 2019
    Last Update Posted:
    Aug 9, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Memorial Sloan Kettering Cancer Center
    Glucose Monitoring
    19-315
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Prediabetic State

    Study Results

    No Results Posted as of Aug 9, 2022