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

Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Device: Blood glucose monitoring system for self-testing FreeStyle Freedom Lite; Device: Blood glucose monitoring system for self-testing GlucoMen® areo; Device: Blood glucose monitoring system for self-testing Contour® Next One; Device: Blood glucose monitoring system for self-testing Accu-Chek® Aviva Connect; Device: Blood glucose monitoring system for self-testing OneTouch® Verio

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03033849

IDT-1608-AL

Details and patient eligibility

About

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).

Enrollment: 189 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

189 participants in 1 patient group

Blood glucose measurement

Experimental group

Description:

Every study subject shall test three out of the five devices. The testing order of the BGMS will be changed on each subject to minimize any order effects on measurement results.

Treatment:

Device: Blood glucose monitoring system for self-testing FreeStyle Freedom Lite

Device: Blood glucose monitoring system for self-testing GlucoMen® areo

Device: Blood glucose monitoring system for self-testing Accu-Chek® Aviva Connect

Device: Blood glucose monitoring system for self-testing Contour® Next One

Device: Blood glucose monitoring system for self-testing OneTouch® Verio