OneTouch Verio Flex System Accuracy Evaluation | NCT03138174

Studies
OneTouch Verio Flex System Accuracy Evaluation

NCT03138174

Sponsor

LifeScan

Status

Completed

Last Update Posted

Jun 28, 2017Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Diabetes Mellitus

Interventions

OneTouch Verio Flex Blood Glucose Monitoring System

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 23, 2017Actual

Primary Completion Date

May 2, 2017Actual

Completion Date

May 2, 2017Actual

First Submitted Date

Apr 28, 2017

First Submission Date that Met QC Criteria

Apr 28, 2017

First Posted Date

May 3, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 27, 2017

Last Update Posted Date

Jun 28, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Clinical System Accuracy Evaluation of the CE Marked One Touch Verio Flex blood glucose monitoring device as per requirements stated in ISO 15197:2015.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diabetes		One group consisting of diabetic subjects	Device: OneTouch Verio Flex Blood Glucose Monitoring System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OneTouch Verio Flex Blood Glucose Monitoring System	Device	Blood Glucose Monitoring System	Diabetes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To meet the requirements of ISO 15197:2015	In order to meet the requirements of ISO 15197:2015 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). 99% of individual glucose measured values shall fall within zones A and B of the Consensus Error Grid for type 1 diabetes.	Four weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Summary of Inclusion Criteria:

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.

Summary of Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Study population will consist of subjects diagnosed with diabetes

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alan Patrick	National Health Service, United Kingdom	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Diabetes Centre, Birmingham Heartlands Hospital		Birmingham		B9 5SS	United Kingdom
Royal Infirmary of Edinburgh

IPD Sharing Statement Module

Plan to Share IPD

Description

De identified data may be shared by way of study reports and publications

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided