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Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
in
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/18/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/18/2021.

Clinical Evaluation of LifeScan Blood Glucose Monitoring Systems

Clinicaltrials.gov identifier NCT03920085

Recruitment Status Completed

First Posted April 18, 2019

Last update posted February 28, 2020

Study Description

Brief summary:

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

  • Condition or Disease:Diabetes Mellitus
  • Intervention/Treatment: Device: OneTouch Verio
    Device: OneTouch Select Plus
    Device: OneTouch Ultra
  • Phase: N/A
Detailed Description

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.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 123 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Other
  • Official Title: Clinical Evaluation of LifeScan Blood Glucose Monitoring Systems
  • Actual Study Start Date: January 2019
  • Actual Primary Completion Date: February 2019
  • Actual Study Completion Date: February 2019
Arms and interventions
Arm Intervention/treatment
Experimental: 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).
Device: OneTouch Verio
OneTouch Verio Blood Glucose Monitoring System.

Device: OneTouch Select Plus
OneTouch Select Plus Blood Glucose Monitoring System.

Device: OneTouch Ultra
OneTouch Ultra Blood Glucose Monitoring System.
Outcome Measures
  • Primary Outcome Measures: 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 (%).
Eligibility Criteria
  • Ages Eligible for Study: 16 Years and older (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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

Contacts and Locations
Contacts
Locations

United Kingdom
MAC Clinical Research
Manchester

Sponsors and Collaborators

LifeScan Scotland Ltd

MAC Clinical Research

More Information
  • Responsible Party: LifeScan Scotland Ltd
  • ClinicalTrials.gov Identifier: NCT03920085 History of Changes
  • Other Study ID Numbers: 3177234
  • First Posted: April 18, 2019 Key Record Dates
  • Last Update Posted: February 28, 2020
  • Last Verified: March 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes