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临床试验/NCT04210128
NCT04210128已完成不适用

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

Memorial Sloan Kettering Cancer Center1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2019年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3
试验地点
1
主要终点
severe hyperglycemia

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

severe hyperglycemia

时间窗: 1 year

glucose \> 400 mg/dL for over 3 contiguous hours

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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