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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Breast Cancer; Diabetes; Pre Diabetes; Pancreatic Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT04210128

19-315

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

3 participants in 2 patient groups

Breast cancer patients

Description:

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

Description:

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.