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

Completed

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

• Registration Number: NCT04210128
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-12-20
• Study First Submitted: 2019-12-20
• Study First Submitted QC: 2019-12-20
• Study First Posted: 2019-12-24
• Status Verified: 2023-10
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
severe hyperglycemia	1 year	glucose \> 400 mg/dL for over 3 contiguous hours

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States