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

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Device: Blood glucose monitoring systems for self-testing (BGMS)

• Registration Number: NCT03085251
• Lead Sponsor: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-15
• Study First Submitted QC: 2017-03-15
• Study Start: 2017-03-16
• Study First Posted: 2017-03-21
• Primary Completion: 2017-04-03
• Study Completion: 2017-06-01
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-25
• Last Update Posted: 2017-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blood glucose measurement	Blood glucose monitoring systems for self-testing (BGMS)	-

Primary Outcome Measures

Name	Time	Method
System accuracy criteria	For each subject, the experimental phase has an expected duration of up to 6 hours	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.

Trial Locations

Locations (1)

Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm; 🇩🇪 Ulm, Baden-Württemberg, Germany