Clinical Evaluation of LifeScan Blood Glucose Monitoring Systems

NCT ID: NCT03920085

Last Updated: 2020-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-08

Study Completion Date

2019-02-05

Brief Summary

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Study to determine the performance of the LifeScan BGMS when conducted at MAC clinical site.

Detailed Description

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This study will evaluate the performance of the MAC clinical site to evaluate accuracy performance of LifeScan blood glucose monitoring systems as it is conducted at other LifeScan UK affiliated clinic sites. Multiple LifeScan Blood Glucose Monitoring System (BGMS) will be tested with production lots which have passed release testing.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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LifeScan BGMSs

OneTouch Verio, OneTouch Select Plus and OneTouch Ultra Blood Glucose Monitoring Systems (BGMSs) tested using subject capillary blood and compared to a reference instrument (YSI 2900).

Group Type EXPERIMENTAL

OneTouch Verio

Intervention Type DEVICE

OneTouch Verio Blood Glucose Monitoring System.

OneTouch Select Plus

Intervention Type DEVICE

OneTouch Select Plus Blood Glucose Monitoring System.

OneTouch Ultra

Intervention Type DEVICE

OneTouch Ultra Blood Glucose Monitoring System.

Interventions

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OneTouch Verio

OneTouch Verio Blood Glucose Monitoring System.

Intervention Type DEVICE

OneTouch Select Plus

OneTouch Select Plus Blood Glucose Monitoring System.

Intervention Type DEVICE

OneTouch Ultra

OneTouch Ultra Blood Glucose Monitoring System.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Participants must be enrolled in LifeScan Patient Registry.
* Participants must have read the Information sheet and signed an informedconsent form \>prior to study participation.
* Participants must be 16 years or older.
* Participants must be diagnosed with Diabetes

Exclusion Criteria

\> Participants not enrolled in the LifeScan Patient Registry
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MAC Clinical Research

OTHER

Sponsor Role collaborator

LifeScan Scotland Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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MAC Clinical Research

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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3177234

Identifier Type: -

Identifier Source: org_study_id

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