Diabetes
Conditions
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.
Interventions
DEVICE6 blood glucose monitoring systems for self-testing (blood glucose meters)
Sponsors
Bayer
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Germany
Outcome results
None listed