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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-20

Study Completion Date

2023-10-31

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.

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Detailed Description

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Conditions

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Breast Cancer Pancreatic Cancer Diabetes Pre Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No