User Performance Evaluation of Contour® Next One, Accu-Chek® Aviva Connect, FreeStyle Freedom Lite, OneTouch® Verio and GlucoMen® Areo Blood Glucose Monitoring Systems Following ISO 15197:2013
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 189
- 试验地点
- 2
- 主要终点
- Acceptance criteria defined by ISO 15197:2013 (E) will be applied
研究概览
简要总结
The user performance evaluation shows whether people with diabetes are able to obtain accurate measurement results with a blood glucose monitoring system. In this study, user performance evaluation will be performed for Contour® Next One (Ascensia Diabetes Care GmbH), Accu-Chek® Aviva Connect (Roche Diabetes Care GmbH), FreeStyle Freedom Lite (Abbott Diabetes Care Inc.), OneTouch® Verio (LifeScan Europe) and GlucoMen® areo A. Menarini Diagnostics S.r.l. (based on ISO 15197:2013; EN ISO 15197:2015, clause 8.
For each BGMS, measurement procedures for user performance evaluation will be performed with 1 test meter and 1 reagent system lot by the study subjects.
The same meter and an additional test meter will be used for double measurements performed by study personnel (with the same reagent system lot used by subjects).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, with type 1 diabetes, type 2 diabetes or subjects without diabetes
- •Signed informed consent form
- •Minimum age of 18 years
- •Subjects are legally competent and capable to understand character, meaning and consequences of the study.
- •If blood glucose values < 80 mg/dl or > 300 mg/dl shall be measured after short term alteration in insulin therapy:
- •Male or female with type 1 diabetes and intensified insulin therapy or insulin pump therapy.
- •Signature of subjects to document consent with these procedures on informed consent form.
排除标准
- •Pregnancy or lactation period
- •Severe acute disease (at the study physician's discretion)
- •Severe chronic disease with potential risk during the test procedures (at the study physician's discretion)
- •Current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
- •Being unable to give informed consent
- •< 18 years
- •Legally incompetent
- •Being committed to an institution (e.g. psychiatric clinic)
- •Language barriers potentially compromising an adequate compliance with study procedures
- •Dependent on investigator or sponsor
- •If blood glucose values < 80 mg/dl shall be measured after short term alteration in insulin therapy, subjects with type 1 diabetes, suffering from:
- •Coronary heart disease
- •Condition after myocardial infarction
- •Condition after cerebral events
- •Peripheral arterial occlusive disease
- •Hypoglycemia unawareness
研究组 & 干预措施
Blood glucose measurement
Every study subject shall test three out of the five devices. The testing order of the BGMS will be changed on each subject to minimize any order effects on measurement results.
干预措施: Blood glucose monitoring system for self-testing GlucoMen® areo (Device)
Blood glucose measurement
Every study subject shall test three out of the five devices. The testing order of the BGMS will be changed on each subject to minimize any order effects on measurement results.
干预措施: Blood glucose monitoring system for self-testing Contour® Next One (Device)
Blood glucose measurement
Every study subject shall test three out of the five devices. The testing order of the BGMS will be changed on each subject to minimize any order effects on measurement results.
干预措施: Blood glucose monitoring system for self-testing Accu-Chek® Aviva Connect (Device)
Blood glucose measurement
Every study subject shall test three out of the five devices. The testing order of the BGMS will be changed on each subject to minimize any order effects on measurement results.
干预措施: Blood glucose monitoring system for self-testing FreeStyle Freedom Lite (Device)
Blood glucose measurement
Every study subject shall test three out of the five devices. The testing order of the BGMS will be changed on each subject to minimize any order effects on measurement results.
干预措施: Blood glucose monitoring system for self-testing OneTouch® Verio (Device)
结局指标
主要结局
Acceptance criteria defined by ISO 15197:2013 (E) will be applied
时间窗: For each subject, the experimental phase has an expected duration of up to 3 hours
95 % of the individual glucose measured values shall fall within ± 15 mg/dl (0.83 mmol/l) of the measured values of the comparison measurement procedure at glucose concentrations \< 100 mg/dl (5.55 mmol/l) and within ± 15 % at glucose concentrations ≥ 100 mg/dl (5.55 mmol/l).
次要结局
未报告次要终点