Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Evaluation of LifeScan Blood Glucose Monitoring Systems

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03920085
Recruitment Status : Completed
First Posted : April 18, 2019
Last Update Posted : February 28, 2020
Sponsor:
Collaborator:
MAC Clinical Research
Information provided by (Responsible Party):
LifeScan Scotland Ltd

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Device: OneTouch Verio Device: OneTouch Select Plus Device: OneTouch Ultra Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: N/A
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 8, 2019
Actual Primary Completion Date : February 5, 2019
Actual Study Completion Date : February 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

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.




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 (%).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920085


Locations
Layout table for location information
United Kingdom
MAC Clinical Research
Manchester, United Kingdom
Sponsors and Collaborators
LifeScan Scotland Ltd
MAC Clinical Research
Layout table for additonal information
Responsible Party: LifeScan Scotland Ltd
ClinicalTrials.gov Identifier: NCT03920085    
Other Study ID Numbers: 3177234
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: February 28, 2020
Last Verified: March 2019

Layout table for additional information
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.: No