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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04210128
• Other study ID #: 19-315
• Status: Completed
• Start date: December 20, 2019
• Est. completion date: October 31, 2023

Study information

• Verified date: October 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Diabetes
• Diabetes Mellitus
• Pancreatic Cancer
• Pre Diabetes
• Prediabetic State

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	severe hyperglycemia	glucose > 400 mg/dL for over 3 contiguous hours	1 year

External Links

•   Memorial Sloan Kettering Cancer Center