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Glucose Monitoring to Predict and Treat High Glucose Levels After Steroid Treatment 3

Completed
Clinical Trial NCT04210128 was an observational study for Breast Cancer, Pancreatic Cancer, Diabetes, Pre Diabetes that is now completed. The study started on December 20, 2019, with plans to enroll 3 participants. Led by Memorial Sloan Kettering Cancer Center, the expected completion date was October 31, 2023. The latest data from ClinicalTrials.gov was last updated on November 1, 2023.
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.
Official Title

Continuous Glucose Monitoring For Prediction and Treatment of Steroid-Induced Hyperglycemia

Conditions
Breast CancerPancreatic CancerDiabetesPre Diabetes
Other Study IDs
  • 19-315
NCT ID Number
NCT04210128
Start Date (Actual)
2019-12-20
Last Update Posted
2023-11-01
Completion Date (Estimated)
2023-10-31
Enrollment (Estimated)
3
Study Type
Observational
Status
Completed
Keywords
Glucose Monitoring
19-315
Arms / Interventions
Participant Group/ArmIntervention/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 stu...Show More
N/A
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 ...Show More
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
severe hyperglycemia
glucose \> 400 mg/dL for over 3 contiguous hours
1 year
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female

  • 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

  • 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.
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1 Study Locations in 1 Countries

New York

Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States