Glycemic Impact on Glioblastoma Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Total time spent in target glucose level
研究概览
简要总结
This pilot study aims to evaluate the feasibility of close glucose monitoring and management of patients (targeting fasting and pre-meal glucose of 4-7 mmol/L) using state-of-the-art flash glucose monitoring (FGM) technology. The glycemic intervention will be personalized based on individual blood glucose levels. Although the glycemic interventions used in this study include standard medications and methods of glucose monitoring used for patients with diabetes, this pilot study will specifically evaluate the feasibility of using these approaches in patients with GBM, appreciating their additional medical, functional and social challenges.
详细描述
The purpose of this pilot study is to determine the feasibility of using close monitoring and management of glucose levels in patients undergoing radiation and chemotherapy for glioblastoma.
The glucose management will include the use of standard metformin a common treatment for patients with early type 2 diabetes that has also shown anti-tumor effects in GBM, and will be further personalized based on individual blood glucose levels. Additional anti-hyperglycemic management will be provided at the discretion of the Endocrinologist.
Close glucose monitoring will include flash glucose monitoring (FGM) with a device called an FreeStyle Libre Pro Flash Glucose Monitoring System, finger-prick glucose measures (standard approach for patients with diabetes) and weekly blood tests (our current standard for patients with GBM).
In addition to determining the feasibility of using these approaches, this pilot study will help identify the simplest and most effective approach of managing glucose levels in patients with GBM appreciating their additional medical, functional and social challenges.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (> 18 years old) with a new histologically-confirmed diagnosis of glioblastoma who are planned to receive a 6-week course of concurrent radiation and temozolomide
- •Has evidence of random glucose of at least 7.8 mmol/L or fasting blood glucose of at least 6.1 mmol/L (meeting criteria for oral diabetic medications)
- •Able to provide informed consent
- •Able to understand and follow instructions regarding self-administered capillary glucose measurements
排除标准
- •Contraindication to MRI with gadolinium
- •Taking anti-hyperglycemic medications at the time of study eligibility screen
- •Unable to participate in neurocognitive evaluation in English
结局指标
主要结局
Total time spent in target glucose level
时间窗: 1 week
total time spent in target range of 4-10 mmol/L based on FGM data during week 6 of radiotherapy and temozolomide therapy
次要结局
- Area under the curve for glycemic exposure and variability(baseline, week 1, 2, 3, 4, 5, 6, 10-13, 3 months)
- prevalence of sensor site problems(From baseline to week 6 - the time from sensor insertion through completion of study intervention)
- Neurocognitive Function(3 month follow up visit)