Clinical trial NCT03033849: User Performance Evaluation of Contour® Next One, Accu-Chek® Aviva Connect, FreeStyle Freedom Lite, OneTouch® Verio and GlucoMen® Areo Blood Glucose Monitoring Systems Following ISO 15197:2013
Official title: User Performance Evaluation of Contour® Next One, Accu-Chek® Aviva Connect, FreeStyle Freedom Lite, OneTouch® Verio and GlucoMen® Areo Blood Glucose Monitoring Systems Following ISO 15197:2013
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Sponsor class: OTHER
Collaborators: name: Ascensia Diabetes Care
First posted: 2017-01-27
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: The user performance evaluation shows whether people with diabetes are able to obtain accurate measurement results with a blood glucose monitoring system. In this study, user performance evaluation will be performed for Contour® Next One (Ascensia Diabetes Care GmbH), Accu-Chek® Aviva Connect (Roche Diabetes Care GmbH), FreeStyle Freedom Lite (Abbott Diabetes Care Inc.), OneTouch® Verio (LifeScan Europe) and GlucoMen® areo A. Menarini Diagnostics S.r.l. (based on ISO 15197:2013; EN ISO 15197:2015, clause 8.

For each BGMS, measurement procedures for user performance evaluation will be performed with 1 test meter and 1 reagent system lot by the study subjects.

The same meter and an additional test meter will be used for double measurements performed by study personnel (with the same reagent system lot used by subjects).


Eligibility criteria: Inclusion Criteria:

* Male or female, with type 1 diabetes, type 2 diabetes or subjects without diabetes
* Signed informed consent form
* Minimum age of 18 years
* 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.

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)
* Current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
* Being unable to give informed consent
* \< 18 years
* Legally incompetent
* Being committed to an institution (e.g. psychiatric clinic)
* Language barriers potentially compromising an adequate compliance with study procedures
* Dependent on investigator or sponsor
* If blood glucose values \< 80 mg/dl shall be measured after short term alteration in insulin therapy, subjects with type 1 diabetes, suffering from:
* Coronary heart disease
* Condition after myocardial infarction
* Condition after cerebral events
* Peripheral arterial occlusive disease
* Hypoglycemia unawareness

Primary outcomes:
measure: Acceptance criteria defined by ISO 15197:2013 (E) will be applied
timeFrame: For each subject, the experimental phase has an expected duration of up to 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
state: Baden-Württemberg
Study officials:
References:
citation: Jendrike N, Baumstark A, Pleus S, Liebing C, Kamecke U, Haug C, Freckmann G. Accuracy of five systems for self-monitoring of blood glucose in the hands of adult lay-users and professionals applying ISO 15197:2013 accuracy criteria and potential insulin dosing errors. Curr Med Res Opin. 2019 Feb;35(2):301-311. doi: 10.1080/03007995.2018.1491832. Epub 2018 Jul 19.