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

September 11, 2017 updated by: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

189

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Ulm, Baden-Württemberg, Germany, 89081
        • Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Blood glucose measurement
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.
Device: Blood glucose monitoring system for self-testing Contour® Next One

This is a user performance study, that is intended to show whether people with diabetes are able to obtain accurate measurement results with a blood glucose monitoring system (BGMS).

The subjects' measurement technique (e.g. applying blood onto the system reagent, reading the result) will be observed and documented by study personnel.

Immediately after the measurement by the subject, the study personnel will perform a measurement with the same test meter.

Measurement results obtained by the subjects with the BGMS will be compared to measurement results obtained with the comparison method.

Sample collection for the comparison measurement will be performed by study personnel within 5 min after the subject's measurement with the test meter.

The samples will be collected from the subjects' skin puncture (if possible), an additional skin puncture (if required) will be documented.

An additional skin puncture will be performed by study personnel with single-use lancing devices.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptance criteria defined by ISO 15197:2013 (E) will be applied
Time Frame: For each subject, the experimental phase has an expected duration of up to 3 hours
95 % of the individual glucose measured values shall fall within ± 15 mg/dl (0.83 mmol/l) of the measured values of the comparison measurement procedure at glucose concentrations < 100 mg/dl (5.55 mmol/l) and within ± 15 % at glucose concentrations ≥ 100 mg/dl (5.55 mmol/l).
For each subject, the experimental phase has an expected duration of up to 3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Ascensia Diabetes Care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

January 16, 2017

First Submitted That Met QC Criteria

January 26, 2017

First Posted (Estimate)

January 27, 2017

Study Record Updates

Last Update Posted (Actual)

September 12, 2017

Last Update Submitted That Met QC Criteria

September 11, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • IDT-1608-AL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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