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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

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ClinicalTrials.gov Identifier: NCT03033849
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : September 12, 2017
Sponsor:
Collaborator:
Ascensia Diabetes Care
Information provided by (Responsible Party):
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

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).


Condition or disease Intervention/treatment Phase
Diabetes Mellitus 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 FreeStyle Freedom Lite Device: Blood glucose monitoring system for self-testing OneTouch® Verio Device: Blood glucose monitoring system for self-testing GlucoMen® areo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 189 participants
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 Start Date : January 2017
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Dextrose

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 Name: 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



Primary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033849


Locations
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Germany
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Ulm, Baden-Württemberg, Germany, 89081
Sponsors and Collaborators
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Ascensia Diabetes Care

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
ClinicalTrials.gov Identifier: NCT03033849     History of Changes
Other Study ID Numbers: IDT-1608-AL
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases