Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis (PRECISE DM Dx)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 45
- 主要终点
- Calculate the Mean Absolute Difference Between A1c-Derived Estimated Average Glucose (eAG) and CGM-Derived eAG
研究概览
简要总结
The goal of this observational study is to learn why some adults over the age of 65, have A1c tests that do not match up with their blood glucose levels, also known as 'A1c-glucose discordance'.
The main question it aims to answer is:
Could alternative tests like CGM or personalized A1c provide more accurate diabetes screening in this population?
Participants will be asked to perform blood tests every week to two weeks and wear a CGM for up to 8 weeks.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 65 years of age or older
- •A1c 5.3% - 7.4% without a diagnosis on the problem list and/or current or prior treatment for diabetes
- •Evidence of A1c discordance by meeting one of two criteria developed by an EHR based algorithm
- •At least five (5) HbA1c values and three (3) CBC values available in the EHR in the previous 10 years
- •Willingness to wear an Abbott Freestyle Libre 3 System Sensor for up to 48 days
- •Willingness to consent to data collection using the electronic health record and sign a medical release to obtain future medical records from other health care facilities
排除标准
- •Known or suspected diabetes of other causes (type 1 diabetes, pancreatogenic diabetes, monogenic diabetes, etc.)
- •Clinically significant anemia based on most recent hematocrit (M = <38%, F <33%) and/or hemoglobin (M = <12 g/dL, F = <10 g/dL) within the last 12 months
- •Condition with short life expectancy
- •Blood (hematologic) malignancy
- •rtCGM-interference agents per manufacturer (e.g., high dose vitamin C)
- •Unstable psychiatric or medical condition
- •Active treatment for cancer, planned treatment for cancer, or recent active cancer with a likelihood of recurrence or progression, that, in the opinion of the site investigator, would interfere with study therapy prior to 2029
- •Allowed Exceptions: Treated cancer with no evidence of disease, no evidence of disease progression, and no planned change in therapy. Examples of allowable cancers include:
- •Breast cancer stable after active treatment, managed with long-term anti-estrogen therapy
- •Prostate cancer being observed
- •Stage 0 or 1 tumors status post resection or other definitive treatment
- •Other similarly stable cancer comorbidities
结局指标
主要结局
Calculate the Mean Absolute Difference Between A1c-Derived Estimated Average Glucose (eAG) and CGM-Derived eAG
时间窗: From 1 week after enrollment to the end of their enrollment at either week 5 or week 10
Determine the mean absolute difference between estimated average glucose (eAG) calculated from hemoglobin A1c and eAG derived from Continuous Glucose Monitoring (CGM) data. This measure will be assessed among participants suspected of having discordance between A1c values and actual blood glucose levels.
次要结局
未报告次要终点
研究者
Marie McDonnell
Associate Professor
Brigham and Women's Hospital