System Accuracy Evaluation of 6 CE-marked Blood Glucose Monitoring System Following ISO 15197:2013

Study Overview
=================
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.

Official Title
-----------------
System Accuracy Evaluation of Accu-Chek Aviva Nano (Roche Diagnostics), Accu-Chek Performa Nano (Roche Diagnostics), FreeStyle Lite (Abbott Diabetes Care), OneTouch Verio IQ (LifeScan), Contour Next Link 2.4 (Bayer Consumer Care), One Additional CE-marked Blood Glucose Monitoring System Following ISO 15197:2013

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Device: 6 blood glucose monitoring systems for self-testing (blood glucose meters)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: 6 blood glucose monitoring systems for self-testing (blood glucose meters)|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System accuracy criteria (see description) | 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). | For each subject, the experimental phase has an expected duration of up to 6 hours |