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

Study Overview
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Brief Summary
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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
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Continuous Glucose Monitoring For Prediction and Treatment of Steroid-Induced Hyperglycemia

Conditions
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Breast Cancer, Pancreatic Cancer, Diabetes, Pre Diabetes

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast cancer patients<br>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<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severe hyperglycemia | glucose > 400 mg/dL for over 3 contiguous hours | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glucose Monitoring, 19-315