NCT02709707已完成不适用
A Lay User Study of the iGlucose, a Device for Self-Monitoring of Blood Glucose (SMBG), Marketed by the Smart Meter Corporation
Nina Peled1 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2016年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Accuracy of blood glucose measurements as performed by lay users
研究概览
简要总结
Evaluation of the iGlucose Blood Glucose Monitoring System in the hands of lay users
详细描述
A non-randomized, prospective study of recruited subjects with diabetes. Subjects will include those with type I or type II diabetes of various duration and those who are naive to self-testing of blood glucose. Subjects will use provided instructions-for-use to undergo self-training on the use of the device and will then self-test their blood glucose level. Results will be compared to those obtained by a lab glucose analyzer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be 12 years of age and older
- •Have pre-existing diagnosis of diabetes
- •Be able to read and understand English
- •Agree to participate in the study
- •Be able and willing to provide informed consent
排除标准
- •Do not meet Inclusion Criteria
- •With Hemophilia or any other bleeding disorder
- •With any condition which in the opinion of the Investigator may place the subject or site staff at excessive risk
- •With physical condition/limitation preventing the use of SMBG on their own
结局指标
主要结局
Accuracy of blood glucose measurements as performed by lay users
时间窗: 10 minutes to produce self blood result and to perform lab comparative method
次要结局
- Assessment by lay users of the ease of use of the iGlucose Blood Glucose Monitoring System(2 -3 hours of going through a self-training session and producing an assessment)
研究者
Nina Peled
Regulatory Consultant
Smart Meter Corporation
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Ease of Use of New Blood Glucose Meter With In-built Insulin Calculator at Home StudyDiabetes MellitusNCT01432275Abbott Diabetes Care179
已完成
不适用
Evaluation of a New Blood Glucose Meter System With Capillary and Venous BloodDiabetes MellitusNCT00797563Ascensia Diabetes Care102
招募中
不适用
iGlucose® Remote Patient Monitoring Device as an Adjunct to Routine Glucose Meter Devices for Glycemic Management and Control in Gestational DiabetesGestational DiabetesType2 DiabetesPregnancy in DiabeticNCT04206748The University of Texas Health Science Center, Houston200
已完成
不适用
Performance of a New Glucose Meter System in Children and Young AdultsDiabetesNCT00985257Ascensia Diabetes Care123
终止
不适用
Satisfaction of Hospitalized Diabetic Patients Using a Continuous Glucose Monitoring SystemInsulin-Dependent DiabetesNCT03411460Centre Hospitalier Universitaire de Nīmes10