AAREN: Continuous Glucose Monitoring Profile Description Under Alpelisib treAtment in Patients With Advanced bREast Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence rate of hyperglycemia
研究概览
简要总结
The purpose of this study is to describe the glycemic profile of postmenopausal women treated with alpelisib plus fulvestrant using a continuous blood sugar monitoring device (FreeStyle Libre Pro) over 14 days
详细描述
AAREN is a monocentric prospective study monitoring glycemic profile in patients treated with alpelisib plus fulvestrant. Patients will wear a noninvasive glucose monitoring sensor, the Freestyle Libre Pro for a 14 day period. Forty patients will be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women suffering breast cancer and eligible to treatment with Alpelisib
- •Age ≥18 years
- •Menopausal women (for at least 24 months)
- •Informed Consent Form signed
排除标准
- •Pregnant ou child-bearing potential women
研究组 & 干预措施
Continuous interstitial glucose measurements
Variations of interstitial glucose are measured during 14 days with FreeStyle Libre Pro
干预措施: FreeStyle Libre Pro (Device)
结局指标
主要结局
Incidence rate of hyperglycemia
时间窗: Day 14
In percentage, measured before breakfast and diner (fasting blood glucose). Hyperglycemia defined as follows: * if diabetes de novo: * capillar or interstitial fasting blood glucose ≥ 1,50 g/L, * OR postprandial interstitial glucose ≥ 2 g/L * OR glucose monitoring indicator ≥ 6,5% * if worsening pre-existing diabetes: * increased capillar or interstitial fasting blood glucose ≥ 0,50 g/L compared to average fasting blood glucose at J-3, J-2 and J-1 * AND postprandial interstitial glucose ≥ + 1,00 g/L compared to average fasting blood glucose at J-3, J-2 et J-1 OR average blood glucose ≥ +0,50 g/L
次要结局
未报告次要终点