System accuracy evaluation of up to 6 blood glucose monitoring systems based on ISO 15197:2013 / EN ISO 15197:2015 - IfDT-2159-I
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 127
研究概览
简要总结
According to ISO 15197:2013 and EN ISO 15197:2015, at least three reagent system lots of a blood glucose monitoring system have to be tested. For each of these three lots, at least 95% of measurement results have to lie within ±15 mg/dl or ±15% of the results obtained with the manufacturer’s reference method for reference results <100 mg/dl or =100 mg/dl, respectively. In addition, at least 99% of results across all three lots have to fall within CEG regions A and B (CEG: Consensus Error Grid). In the primary analysis versus the manufacturer’s reference method (for system A Cobas Integra 400 plus, hexokinase-based, for system B to F YSI 2300 STAT Plus, glucose oxidase-based), the following results were found (n = 200 measurement results each): - System A: 99.5% within ±15 mg/dl or ±15%, 100.0% within CEG regions A and B - System B: 94.0% within ±15 mg/dl or ±15%, 100.0% within CEG regions A and B - System C: 100.0% within ±15 mg/dl or ±15%, 100.0% within CEG regions A and B - System D: 95.0% within ±15 mg/dl or ±15%, 100.0% within CEG regions A and B - System E: 95.5% within ±15 mg/dl or ±15%, 100.0% within CEG regions A and B - System F: 97.0% within ±15 mg/dl or ±15%, 100.0% within CEG regions A and B In the secondary analysis versus the alternative comparator (for system A YSI 2300 STAT Plus, glucose oxidase-based, for system B to F Cobas Integra 400 plus, hexokinase-based), the following results were found (n = 200 measurement results each): - System A: 100.0% within ±15 mg/dl or ±15%, 100.0% within CEG regions A and B - System B: 81.5% within ±15 mg/dl or ±15%, 100.0% within CEG regions A and B - System C: 100.0% within ±15 mg/dl or ±15%, 100.0% within CEG regions A and B - System D: 99.0% within ±15 mg/dl or ±15%, 100.0% within CEG regions A and B - System E: 95.5% within ±15 mg/dl or ±15%, 100.0% within CEG regions A and B - System F: 92.0% within ±15 mg/dl or ±15%, 100.0% within CEG regions A and B
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Signed informed consent form
- •- 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 if venous samples are needed
- •- Severe acute disease that compromises the subject’s capability to participate in the study (at the study physician’s discretion)
- •- Severe chronic disease with potential risk during the test procedures (at the study physician’s discretion)
- •- Medical relevant anemia
- •- Suspected lack of compliance
- •- Dependence on investigator or sponsor
- •- If blood glucose values < 80 mg/dl shall be measured after short term alteration in insulin therapy:
- •- Pregnancy or lactation period
- •- Subjects with type 1 diabetes, suffering from
- •- Coronary heart disease
- •- Condition after myocardial infarction
- •- Condition after cerebral events
- •- Peripheral arterial occlusive disease
- •- Hypoglycemia unawareness