System accuracy evaluation of 7 blood glucose monitoring systems based on ISO 15197:2013 / EN ISO 15197:2015
- Conditions
- E14Unspecified diabetes mellitus
- Registration Number
- DRKS00023524
- Lead Sponsor
- Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (IfDT)
- Brief Summary
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 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 all systems YSI 2300 STAT Plus, glucose oxidase-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: 95.0% within ±15 mg/dl or ±15%, 100.0% within CEG regions A and B - System C: 96.0% within ±15 mg/dl or ±15%, 100.0% within CEG regions A and B - System D: 87.0% within ±15 mg/dl or ±15%, 100.0% within CEG regions A and B - System E: 95.0% within ±15 mg/dl or ±15%, 100.0% within CEG regions A and B - System F: 66.0% within ±15 mg/dl or ±15%, 100.0% within CEG regions A and B - System G: 89.0% within ±15 mg/dl or ±15%, 100.0% within CEG regions A and B In the secondary analysis versus the alternative comparator (for all systems Cobas Integra 400 plus, hexokinase-based), the following results were found (n = 200 measurement results each): - System A: 98.5% within ±15 mg/dl or ±15%, 100.0% within CEG regions A and B - System B: 91.5% within ±15 mg/dl or ±15%, 100.0% within CEG regions A and B - System C: 88.0% within ±15 mg/dl or ±15%, 100.0% within CEG regions A and B - System D: 93.5% within ±15 mg/dl or ±15%, 100.0% within CEG regions A and B - System E: 89.5% within ±15 mg/dl or ±15%, 100.0% within CEG regions A and B - System F: 42.0% within ±15 mg/dl or ±15%, 100.0% within CEG regions A and B - System G: 77.5% within ±15 mg/dl or ±15%, 100.0% within CEG regions A and B
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 124
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.
- 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of measurement results within ±15 mg/dl (für blood glucose concentrations <100 mg/dl) or within ±15% (=100 mg/dl) of comparison measurement results
- Secondary Outcome Measures
Name Time Method Percentage of results within zones A and B of the Consensus Error Grid