NCT02073058已完成不适用
Evaluation of the Accuracy of the Abbott Sensor Based Interstitial Glucose Monitoring System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 4
- 主要终点
- Clinical point accuracy as assessed by the Consensus Error Grid
研究概览
简要总结
The purpose of this study is to demonstrate point accuracy of the Abbott Sensor Based Glucose Monitoring (GM) System interstitial glucose results against Reader capillary Blood Glucose (BG) reference using the Consensus Error Grid. During the course of the wear duration, the subject is required to test fingerstick glucose measurement at least eight (8) times a day for capillary reference glucose measurements and three in-clinic visits of a maximum 13 hours each for venous reference glucose measurements. With every reference measurement, the subject or study staff will perform a measurement on the System.
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
- •Subject must be at least 18 years of age.
- •Subject must have type 1 or type 2 diabetes for at least 2 years prior to enrollment.
- •Subject must require insulin therapy through an insulin pump and/or multiple daily insulin injections (at least 3 injections daily) for at least 6 months prior to enrollment.
- •Subject must be able to read and understand English.
- •In the investigator's opinion, the subject must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.
- •Subject must be available to participate in all study visits.
- •Subject must be willing and able to provide written signed and dated informed consent.
排除标准
- •Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
- •Subject is pregnant, attempting to conceive or not willing and able to practice birth control during the study duration (applicable to female subjects only).
- •Subject has skin lesions, scarring, redness, infection or edema at the application sites that could interfere with device placement or the accuracy of interstitial glucose measurements.
- •Subject currently is participating in another clinical trial.
- •Subject has donated blood within 112 days (3.7 months) prior to the beginning of the study activities.
- •Subject has concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff. Such conditions include but are not limited to:
- •History of HIV, Hepatitis B or C
- •Subject has a known medical condition that, in the opinion of the investigator, may increase the risk of bleeding.
- •Subject has X-ray, MRI or CT appointment scheduled during the period of study participation, and the appointment cannot be rescheduled for a time before study participation starts or after study participation ends.
- •Subject is unsuitable for participation due to any other cause as determined by the Investigator.
结局指标
主要结局
Clinical point accuracy as assessed by the Consensus Error Grid
时间窗: 14 days
次要结局
- Composite measure: Technical point accuracy (difference measures, Bland-Altman analysis, regression and percentage within ranges of the reference)(14 days)
- Safety endpoints that include signs and symptoms related to sensor application site(14 days)
- Composite measure: Clinical point accuracy (Clarke Error Grid), trend accuracy (R-deviation, Rate Error Grid and Continuous Glucose Error Grid) and lag time, performance of notifications (sensitivity and false notifications) and questionnaire responses.(14 days)
研究者
研究点 (4)
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