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OpenTrials
Completed

NCT Number: NCT03920085

Clinical Evaluation of LifeScan Blood Glucose Monitoring Systems

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

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MAC Clinical Research

Manchester, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OneTouch Verio

Device

OneTouch Verio Blood Glucose Monitoring System.

OneTouch Select Plus

Device

OneTouch Select Plus Blood Glucose Monitoring System.

OneTouch Ultra

Device

OneTouch Ultra Blood Glucose Monitoring System.

Primary outcomes

  1. Clinical Evaluation of Blood Glucose result (mg/dl) from LifeScan Blood Glucose Monitoring Systems by comparison of a blood glucose result (mg/dl) obtained from a reference instrument (YSI2900) to demonstrate accuracy (%).

    Time frame: Less than 30 minutes

    Clinical Evaluation of Blood Glucose result (mg/dl) from LifeScan Blood Glucose Monitoring Systems by comparison of a blood glucose result (mg/dl) obtained from a reference instrument (YSI2900) to demonstrate accuracy (%).

Sponsors and collaborators

Lead sponsor

LifeScan Scotland Ltd

Industry

Collaborators

  • MAC Clinical Research

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 18, 2019
Registry last updated
Feb 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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