OTVFSA: OneTouch Verio Flex System Accuracy Evaluation

• Sponsor: LifeScan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03138174
• Collaborator: (none)
• Enrollment: 100
• Locations: 3
• Actual Duration (Months): 1.3
• Patients Per Site: 33.3
• Patients Per Site Per Month: 25.4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Device: OneTouch Verio Flex Blood Glucose Monitoring System

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Other
• Time Perspective: Other
• Official Title: OneTouch Verio Flex System Accuracy Evaluation
• Actual Study Start Date: Mar 23, 2017
• Actual Primary Completion Date: May 2, 2017
• Actual Study Completion Date: May 2, 2017

Arms and Interventions

Arm	Intervention/Treatment
Diabetes One group consisting of diabetic subjects	Device: OneTouch Verio Flex Blood Glucose Monitoring System; Blood Glucose Monitoring System

Outcome Measures

Primary Outcome Measures

1. To meet the requirements of ISO 15197:2015 [Four weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Diabetes Centre, Birmingham Heartlands Hospital	Birmingham		United Kingdom	B9 5SS
2	Royal Infirmary of Edinburgh	Edinburgh		United Kingdom	EH16 4SA
3	Highland Diabetes Institute	Inverness		United Kingdom	IV2 3JH

Sponsors and Collaborators

• LifeScan

Investigators

• Principal Investigator: Alan Patrick, National Health Service, United Kingdom

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: LifeScan
• ClinicalTrials.gov Identifier: NCT03138174
• Other Study ID Numbers: WI3052203
• First Posted: May 3, 2017
• Last Update Posted: Jun 28, 2017
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by LifeScan: Blood Glucose Monitor System Accuracy

Study Results

No Results Posted as of Jun 28, 2017