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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

Tracking Information
First Submitted Date  ICMJE January 16, 2017
First Posted Date  ICMJE January 27, 2017
Last Update Posted Date September 12, 2017
Study Start Date  ICMJE January 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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 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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Not Provided
Condition  ICMJE Diabetes Mellitus
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • 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
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 11, 2017)
189
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2017)
200
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03033849
Other Study ID Numbers  ICMJE IDT-1608-AL
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Study Sponsor  ICMJE Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Collaborators  ICMJE Ascensia Diabetes Care
Investigators  ICMJE Not Provided
PRS Account Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP