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

NCT03085251 | Completed

• 1 other identifier: IDT-1653-LI
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Blood glucose measurement

EXPERIMENTAL

Device: Blood glucose monitoring systems for self-testing (BGMS)

Interventions

Blood glucose monitoring systems for self-testing (BGMS) DEVICE

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.

Also known as: OneTouch® Verio Flex

Blood glucose measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

Ulm, Baden-Wurttemberg, 89081, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Self-Testing

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Self Care; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: March 21, 2017
• Study Start: March 16, 2017
• Primary Completion: April 3, 2017
• Study Completion: June 1, 2017
• Last Updated: September 26, 2017

Record last verified: 2017-09

Locations

DE (1)