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Completed

NCT Number: NCT02053584

Dario™ Blood Glucose Monitoring System - User Performance Evaluation

The study is performed to evaluate the accuracy of blood glucose level results obtained from fingertip using Labstyle Dario Blood Glucose Monitoring System (BGMS) compared to reference equipment (YSI 2300 STATPLUS) and to evaluate the ease of use of the Dario Device by the lay-person.

The participants will review the Dario user manual and guide and will be requested to operate the Dario BGMS and perform their own glucose blood test, after which they will be asked to complete a questionnaire. As reference the participants will be tested by professional caregivers both using the Dario BGMS and by YSI 2003.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Study type

Interventional

Phase

Not applicable

About this study

Device accuracy will be assessed based on the acceptance criteria of ISO 15197:2003 which states: "The minimum acceptable accuracy for results produced by a glucose monitoring system shall be as follows: 95% of the individual glucose results shall fall within 15 mg/dL of the results of Reference method at glucose concentrations ≥ 4,2 mmol/L (≥ 75 mg/dL)".

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female between the age 18 and 80
  • Type 1 and Type 2 diabetes

Exclusion criteria

  • Drug and alcohol abuse
  • Investigator discretion

Treatment and study plan

Dario™ Blood Glucose Meter

Device

Each subject will undergo a finger prick and also provide a venous blood sample

YSI2003

Device

Blood samples will be tested using YSI (gold standard) for comparison to evaluate accuracy.

Primary outcomes

  1. BGMS Accuracy Assessment When Used by Layperson

    Time frame: Within 6 seconds of applying blood drop to strip

    The minimum acceptable accuracy for results produced by a glucose monitoring system shall be as follows: 95% of the individual glucose results shall fall within 15 mg/dL of the results of reference method (YSI) at glucose concentrations ≥ 4,2 mmol/L (≥ 75 mg/dL). (ISO 15197:2003)

Secondary outcomes

  1. Evaluation of the Ease of Use of the Dario BGMS by the Lay-person

    Time frame: Within a couple of hours from the time labelling material was provided to the subject

    Each participant receives a survey to fill in describing their usage of the device and their opinions on the ease of use.

Sponsors and collaborators

Lead sponsor

LabStyle Innovations Ltd.

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 3, 2014
Registry last updated
Dec 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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