<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03033849</url>
  </required_header>
  <id_info>
    <org_study_id>IDT-1608-AL</org_study_id>
    <nct_id>NCT03033849</nct_id>
  </id_info>
  <brief_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</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ascensia Diabetes Care</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm</source>
  <brief_summary>
    <textblock>
      The user performance evaluation shows whether people with diabetes are able to obtain&#xD;
      accurate measurement results with a blood glucose monitoring system. In this study, user&#xD;
      performance evaluation will be performed for Contour® Next One (Ascensia Diabetes Care GmbH),&#xD;
      Accu-Chek® Aviva Connect (Roche Diabetes Care GmbH), FreeStyle Freedom Lite (Abbott Diabetes&#xD;
      Care Inc.), OneTouch® Verio (LifeScan Europe) and GlucoMen® areo A. Menarini Diagnostics&#xD;
      S.r.l. (based on ISO 15197:2013; EN ISO 15197:2015, clause 8.&#xD;
&#xD;
      For each BGMS, measurement procedures for user performance evaluation will be performed with&#xD;
      1 test meter and 1 reagent system lot by the study subjects.&#xD;
&#xD;
      The same meter and an additional test meter will be used for double measurements performed by&#xD;
      study personnel (with the same reagent system lot used by subjects).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <primary_outcome>
    <measure>Acceptance criteria defined by ISO 15197:2013 (E) will be applied</measure>
    <time_frame>For each subject, the experimental phase has an expected duration of up to 3 hours</time_frame>
    <description>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 &lt; 100 mg/dl (5.55 mmol/l) and within ± 15 % at glucose concentrations ≥ 100 mg/dl (5.55 mmol/l).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">189</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Blood glucose measurement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Blood glucose monitoring system for self-testing Contour® Next One</intervention_name>
    <description>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).&#xD;
The subjects' measurement technique (e.g. applying blood onto the system reagent, reading the result) will be observed and documented by study personnel.&#xD;
Immediately after the measurement by the subject, the study personnel will perform a measurement with the same test meter.&#xD;
Measurement results obtained by the subjects with the BGMS will be compared to measurement results obtained with the comparison method.&#xD;
Sample collection for the comparison measurement will be performed by study personnel within 5 min after the subject's measurement with the test meter.&#xD;
The samples will be collected from the subjects' skin puncture (if possible), an additional skin puncture (if required) will be documented.&#xD;
An additional skin puncture will be performed by study personnel with single-use lancing devices.</description>
    <arm_group_label>Blood glucose measurement</arm_group_label>
    <other_name>Contour® Next One, Accu-Chek® Aviva Connect, FreeStyle Freedom Lite, OneTouch® Verio, GlucoMen® areo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Blood glucose monitoring system for self-testing Accu-Chek® Aviva Connect</intervention_name>
    <arm_group_label>Blood glucose measurement</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Blood glucose monitoring system for self-testing FreeStyle Freedom Lite</intervention_name>
    <arm_group_label>Blood glucose measurement</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Blood glucose monitoring system for self-testing OneTouch® Verio</intervention_name>
    <arm_group_label>Blood glucose measurement</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Blood glucose monitoring system for self-testing GlucoMen® areo</intervention_name>
    <arm_group_label>Blood glucose measurement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, with type 1 diabetes, type 2 diabetes or subjects without diabetes&#xD;
&#xD;
          -  Signed informed consent form&#xD;
&#xD;
          -  Minimum age of 18 years&#xD;
&#xD;
          -  Subjects are legally competent and capable to understand character, meaning and&#xD;
             consequences of the study.&#xD;
&#xD;
          -  If blood glucose values &lt; 80 mg/dl or &gt; 300 mg/dl shall be measured after short term&#xD;
             alteration in insulin therapy:&#xD;
&#xD;
          -  Male or female with type 1 diabetes and intensified insulin therapy or insulin pump&#xD;
             therapy.&#xD;
&#xD;
          -  Signature of subjects to document consent with these procedures on informed consent&#xD;
             form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or lactation period&#xD;
&#xD;
          -  Severe acute disease (at the study physician's discretion)&#xD;
&#xD;
          -  Severe chronic disease with potential risk during the test procedures (at the study&#xD;
             physician's discretion)&#xD;
&#xD;
          -  Current constitution that compromises the subject's capability to participate in the&#xD;
             study (at the study physician's discretion)&#xD;
&#xD;
          -  Being unable to give informed consent&#xD;
&#xD;
          -  &lt; 18 years&#xD;
&#xD;
          -  Legally incompetent&#xD;
&#xD;
          -  Being committed to an institution (e.g. psychiatric clinic)&#xD;
&#xD;
          -  Language barriers potentially compromising an adequate compliance with study&#xD;
             procedures&#xD;
&#xD;
          -  Dependent on investigator or sponsor&#xD;
&#xD;
          -  If blood glucose values &lt; 80 mg/dl shall be measured after short term alteration in&#xD;
             insulin therapy, subjects with type 1 diabetes, suffering from:&#xD;
&#xD;
          -  Coronary heart disease&#xD;
&#xD;
          -  Condition after myocardial infarction&#xD;
&#xD;
          -  Condition after cerebral events&#xD;
&#xD;
          -  Peripheral arterial occlusive disease&#xD;
&#xD;
          -  Hypoglycemia unawareness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm</name>
      <address>
        <city>Ulm</city>
        <state>Baden-Württemberg</state>
        <zip>89081</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>September 11, 2017</last_update_submitted>
  <last_update_submitted_qc>September 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03033849
org study id: IDT-1608-AL
nct id: NCT03033849
lead sponsor: 
collaborator: 
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).
measure: 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
description: 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).
arm group label: Blood glucose measurement
arm group type: Experimental
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.
intervention type: Device
intervention name: Blood glucose monitoring system for self-testing Contour® Next One
description: 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.
arm group label: Blood glucose measurement
other name: Contour® Next One, Accu-Chek® Aviva Connect, FreeStyle Freedom Lite, OneTouch® Verio, GlucoMen® areo
intervention type: Device
intervention name: Blood glucose monitoring system for self-testing Accu-Chek® Aviva Connect
arm group label: Blood glucose measurement
intervention type: Device
intervention name: Blood glucose monitoring system for self-testing FreeStyle Freedom Lite
arm group label: Blood glucose measurement
intervention type: Device
intervention name: Blood glucose monitoring system for self-testing OneTouch® Verio
arm group label: Blood glucose measurement
intervention type: Device
intervention name: Blood glucose monitoring system for self-testing GlucoMen® areo
arm group label: Blood glucose measurement
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Germany
responsible party type: Sponsor