OneTouch Verio Flex System Accuracy Evaluation

NCT03138174 | Completed FDA Device

• 1 other identifier: WI3052203
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

Clinical System Accuracy Evaluation of the CE Marked One Touch Verio Flex blood glucose monitoring device as per requirements stated in ISO 15197:2015. To meet the requirements, glucose samples must be distributed over the operating range of the blood glucose monitor as stipulated in ISO:15197

Conditions

Diabetes Mellitus

Keywords

Blood Glucose Monitor System Accuracy

Outcome Measures

Primary Outcomes (1)

• To meet the requirements of ISO 15197:2015

  In order to meet the requirements of ISO 15197:2015 1. For each lot individually, 95% of the individual glucose results shall fall within either +0.83 mmol/L (+ 15 mg/dL) of the average measured values of the reference measurement procedure at glucose concentration intervals \< 5.55 mmol/L (\< 100 mg/dL) or within + 15 % at glucose concentrations \> 5.55 mmol/L (\> 100 mg/dL). 2. 99% of individual glucose measured values shall fall within zones A and B of the Consensus Error Grid for type 1 diabetes.

  Four weeks

Study Arms (1)

Diabetes

One group consisting of diabetic subjects

Device: OneTouch Verio Flex Blood Glucose Monitoring System

Interventions

OneTouch Verio Flex Blood Glucose Monitoring System DEVICE

Blood Glucose Monitoring System

Diabetes

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population will consist of subjects diagnosed with diabetes

You may qualify if:

• All Subjects must be registered into the LFSS Patient Registry to participate in the study.
• Each Participant must read and sign the approved Informed Consent Form.
• Diabetes Diagnosis - Participants should be diagnosed with some form of diabetes for system accuracy.

You may not qualify if:

• \> Subjects not enrolled in the LFSS Patient Registry are not eligible to participate in the study.

Sponsors & Collaborators

• LifeScan: lead

Study Sites (3)

Diabetes Centre, Birmingham Heartlands Hospital

Birmingham, B9 5SS, United Kingdom

Location

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

Highland Diabetes Institute

Inverness, IV2 3JH, United Kingdom

Location

Biospecimen

Retention: NONE RETAINED

Capillary blood samples

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Alan Patrick

  National Health Service, United Kingdom

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2017
• First Posted: May 3, 2017
• Study Start: March 23, 2017
• Primary Completion: May 2, 2017
• Study Completion: May 2, 2017
• Last Updated: June 28, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)