System Accuracy Evaluation of 6 CE-marked Blood Glucose Monitoring System Following ISO 15197:2013
- Conditions
- Diabetes
- Registration Number
- NCT02531386
- Lead Sponsor
- Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
- Brief Summary
The objective of this study is the evaluation of system accuracy following ISO 15197:2013 (E), clause 6.3 in which accuracy requirements and applicable test procedures for blood glucose monitoring systems intended for self-monitoring of blood glucose by patients are stipulated. In this study, system accuracy evaluation will be performed with CE-marked BGMS (BGMS = Blood Glucose Monitoring System) common among insulin pump users - Accu-Chek Aviva Nano and Accu-Chek Performa Nano (Roche Diagnostics), FreeStyle Lite (Abbott Diabetes Care), OneTouch Verio IQ (LifeScan) Contour Next Link 2.4 (Bayer Healthcare Diabetes Care) and Accu-Chek Mobile with three different reagent system lots for each BGMS.
The study will be performed in 2 parts. Each part will comprise testing of 3 BGMS.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
-
Male or female, with type 1 diabetes, type 2 diabetes or no diabetes
-
For provoked blood glucose excursions due to insulin dose adjustment:
- Male or female with type 1 diabetes or
- Type 2 diabetes and intensified insulin therapy or insulin pump therapy.
-
Minimum age of 18 years
-
Signed informed consent form
-
Legally competent and capable to understand character, meaning and consequences of the study
- 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)
- Physical or mental constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
- Incapability of giving informed consent
- < 18 years
- Legally incompetent
- Accommodated in an institution (e.g. psychiatric clinic)
- Language barriers potentially compromising an adequate compliance with study procedures
- Dependent from investigator or sponsor
- For provoked blood glucose excursions 50 - 80 mg/dl (concentration category 2):
- Coronary heart disease
- Condition after myocardial infarction
- Cerebral incidence
- Peripheral arterial occlusive disease
- Hypoglycemia unawareness
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method System accuracy criteria (see description) For each subject, the experimental phase has an expected duration of up to 6 hours System accuracy criteria
Following ISO 15197:2013 (E), the BGMS shall meet both of the following criteria:
Criterion A: 95 % of the measured glucose values shall fall within either ± 15 mg/dl (0.83 mmol/l) of the average comparison measurement result at glucose concentrations \< 100 mg/dl (5.55 mmol/l) or within ± 15 % at glucose concentrations ≥ 100 mg/dl (5.55 mmol/l).
Each lot shall pass acceptability criterion A.
Criterion B: 99 % of individual glucose measured values shall fall within zones A and B of the Consensus Error Grid (CEG) for type 1 diabetes.
Applying ISO 15197:2003 accuracy criteria:
95 % of the measured glucose values shall fall within either ± 15 mg/dl (0.83 mmol/l) of the average comparison measurement result at glucose concentrations \< 75 mg/dl (4.2 mmol/l) or within ± 20 % at glucose concentrations ≥ 75 mg/dl (4.2 mmol/l).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
🇩🇪Ulm, Germany