Clinical System Accuracy Evaluation With OneTouch® Verio Flex Blood Glucose Monitoring System (BGMS)

The objective of this study is the evaluation of system accuracy based on EN ISO 15197:2015 (ISO 15197:2013), clause 6.3 in which accuracy requirements and applicable test procedures for blood glucose monitoring systems intended for self-monitoring of blood glucose by patients are stipulated. ISO 15197:20132 was harmonized with the regulations of the European Union as EN ISO 15197:2015. This harmonization had no impact on the requirements and procedu¬res in ISO 15197:2013; changes were made to the foreword and an informative annex. In this study, system accuracy evaluation will be performed for OneTouch® Verio Flex (LifeScan Europe) on behalf of LifeScan Scotland Limited (customer) with three different reagent system lots.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: Blood glucose monitoring systems for self-testing (BGMS)

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• 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 (concentration category 2), 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

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Blood glucose measurement

Device: Blood glucose monitoring systems for self-testing (BGMS); Measurement procedure; Subjects will be asked to wash and dry their hands before the measurements.; The measurement procedure for each reagent system lot of a BGMS will be as follows:; Study personnel will collect a capillary blood sample from the subject's fingertip by skin puncture.; Duplicate measurements on the sample will be consecutively performed with 2 test meters using reagent system units from the same vial / package.; Capillary blood for measurements with all 3 test strip lots and for both comparison measurements will be taken from the same finger puncture.; The sample will be applied to the reagent system units following specifications in the manufacturer's labelling.; Other Names: OneTouch® Verio Flex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
System accuracy criteria	Based on EN ISO 15197:2015 (ISO 15197:2013) (E), the BGMS shall meet both of the following criteria: Criterion A: 95 % of the measured glucose values shall fall within either ± 15 mg/dl (0.83 mmol/l) of the average comparison measurement result at glucose concentrations < 100 mg/dl (5.55 mmol/l) or within ± 15 % at glucose concentrations ≥ 100 mg/dl (5.55 mmol/l). Each lot shall pass acceptability criterion A. Criterion B: 99 % of individual glucose measured values shall fall within zones A and B of the Consensus Error Grid (CEG) for type 1 diabetes.	For each subject, the experimental phase has an expected duration of up to 6 hours

Collaborators and Investigators

• Sponsor: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
• Collaborators: LifeScan

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 16, 2017
• Primary Completion (ACTUAL): April 3, 2017
• Study Completion (ACTUAL): June 1, 2017

Study Registration Dates

• First Submitted: March 15, 2017
• First Submitted That Met QC Criteria: March 15, 2017
• First Posted (ACTUAL): March 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 26, 2017
• Last Update Submitted That Met QC Criteria: September 25, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: IDT-1653-LI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No