Accuracy of Continuous Glucose Monitors During the Perioperative Period in Youth With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Accuracy of CGM compared to blood glucose using standard statistical methods including mean absolute relative difference (MARD).
研究概览
简要总结
This study is assessing the accuracy of continuous glucose monitors during surgical procedures requiring anesthesia.
详细描述
This study is an observational study design that includes collection of continuous glucose data and venous blood glucose data (from either an IV or fingerstick) from a blood glucose meter. All subjects will be undergoing a surgical procedure that requires anesthesia. The primary outcome of this study is to evaluate the accuracy of the CGM glucose values in comparison to the reference glucometer glucose value during anesthesia. There is currently limited data on accuracy of CGMs during these events and therefore it is not know whether CGM glucose data is reliable to be used as the sole source of glucose monitoring during surgery.
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
- 2 Years 至 26 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants will be 2 to 26 years of age at the time of enrollment.
- •Participants will have a diagnosis of type 1 diabetes on insulin therapy and requiring close glucose monitoring during the hospitalization and the perioperative period.
- •Participant currently wearing a continuous glucose monitor (for example: Dexcom G6 or G7; Freestyle Libre 2, 2 Plus, or 3; Medtronic Guardian 3 or 4; or future sensors as they become available) for home diabetes management and willing to share personal CGM data with the BDC clinical CGM account.
排除标准
- •Currently using hydroxyurea.
- •A condition that the investigator determines would prevent the patient from participation.
研究组 & 干预措施
Pediatric patients undergoing anesthesia
Pediatric patients who are undergoing a surgical procedure with anesthesia. Patients will have type 1 diabetes and be wearing a continuous glucose monitor as part of routine care.
结局指标
主要结局
Accuracy of CGM compared to blood glucose using standard statistical methods including mean absolute relative difference (MARD).
时间窗: Perioperatively (length of time will vary based on the operative procedure)
Accuracy assessment will be completed comparing CGM glucose values to blood glucose values using standard statistical assessments.
次要结局
未报告次要终点