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Completed

NCT Number: NCT04210128

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

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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Diabetes Diabetes Mellitus Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Pre Diabetes Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. severe hyperglycemia

    Time frame: 1 year

    glucose > 400 mg/dL for over 3 contiguous hours

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Dec 24, 2019
Registry last updated
Nov 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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