CTRI/2012/02/002404已完成4 期
OneTouch® SelectSimple� BGMS Clinical Evaluation Protocol: Comparison to a Validated Method and Marketing Claims Study
Johnson and Johnson Ltd0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1.Age â?? Each Subject will be at least 18 years old.
- •2.Informed Consent â?? Each potential Subject must read and sign an Independent Ethics Committee (IEC) approved Information Sheet and Informed Consent Form
- •3.Personal Health Information (PHI) â?? The Subject (enrollee) agrees to provide demographic and medical history information and allow access to medical records when necessary.
- •4. Diabetes Diagnosis â?? The Subject has a current diagnosis of type 1 or type 2 diabetes.
- •5.Self-Monitoring â?? The Subject is currently performing self-monitoring of blood glucose (SMBG) using a non-OneTouch meter and the subject has been self-testing with the non-OneTouch meter without assistance for at least 1 month.
- •6.Language â?? The Subject reads and understands English.
- •7.Study Activities â?? The Subject agrees to complete all aspects of the study, including fingertip self-lancings.
排除标准
- •1.Conflict of Interest â?? The Subject is currently working for, has previously worked for, or has an immediate family member working for a company that manufactures or markets blood glucose monitoring products.
- •2.Technical Expertise â?? The Subject has laboratory training or phlebotomy experience (medical technologist, phlebotomist, laboratory technician, laboratory assistant performing laboratory tests, etc.)
- •3.Pregnancy â??The Subject is pregnant.
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