A Prospective Open-Label Trial Comparing the Accuracy and Reliability of LINX Continuous Glucose Monitor (CGM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Accuracy-Mean absolute relative difference (MARD), error grid analysis, correlation metrics, glycemic range metrics.
研究概览
简要总结
This prospective, open-label, multicentric, parallel-use interventional trial will evaluate the accuracy, reliability, and user experience of three CGM systems-LINX (MicroTech Medical), Abbott FreeStyle Libre, and iCAN (Sinocare Inc.) against capillary blood glucose (CBG) as the reference standard. A total of 150 adults (75 with T2DM and 75 without diabetes) will be enrolled across three clinical sites in Bangalore, India, where all participants will simultaneously wear the three CGMs for 14 to 15 days (LINX on the left arm, Abbott on the right arm, and iCAN on the abdomen), with greater than or equal to 32 paired CBG readings collected. Primary endpoints include mean absolute relative difference (MARD) (less than 15 percent), error grid analysis (greater than 95 percent values in Zones A and B), correlation with CBG, and glycemic range metrics (time in range (TIR), time above range (TAR), time below range (TBR), in percentage). Secondary endpoints assess usability, satisfaction, adherence to SMBG, data reliability, and safety (skin or device-related events).
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Willing and able to wear all three CGM sensors (Linx, Abbott, and i-Can) simultaneously for 14-15 days.
- •Willing to perform structured capillary blood glucose testing as per protocol.
- •Capable of understanding the study requirements and providing written informed consent.
- •No participation in any other clinical study within the past 30 days.
排除标准
- •Diagnosed with type 1 diabetes or a recent episode of diabetic ketoacidosis (within the past 3 months).
- •Pregnant or lactating individuals.
- •Presence of chronic skin conditions or dermatological issues that may interfere with sensor placement.
- •Severe comorbidities or conditions that may impair study compliance (e.g. Cognitive impairment, psychiatric illness).
- •End-stage renal disease or significant renal impairment (e-GFR less than 30 ml/min/1.73 meter square).
- •Use of medications or medical devices that may interfere with CGM function or study outcomes, including substances affecting CGM performance (e.g. Hydroxyurea, acetaminophen, high dose Vitamin C), anticoagulants (except acetylsalicylic acid less than or equal to 100 mg), cardiac pacemakers or similar medical devices.
- •Planned medical procedures during the study that may impact CGM performance (e.g. MRI, CT scan, radio frequency ablation, high frequency electrical heat or high intensity focused ultrasound).
结局指标
主要结局
Accuracy-Mean absolute relative difference (MARD), error grid analysis, correlation metrics, glycemic range metrics.
时间窗: baseline and after 2 weeks
次要结局
- User experience & satisfaction, sensor usability, sensor data reliability, adherence to SMBG protocol, safety & tolerability.(Baseline & after 2 weeks)
研究者
Dr Chhavi Mehra
Ragus Healthcare Pvt Ltd