Clinical Evaluation of LifeScan Blood Glucose Monitoring Systems

Diabetes Mellitus Clinical Trial

Official title:

Clinical Evaluation of LifeScan Blood Glucose Monitoring Systems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03920085
• Other study ID #: 3177234
• Status: Completed
• Phase: N/A
• Start date: January 8, 2019
• Est. completion date: February 5, 2019

Study information

• Verified date: March 2019
• Source: LifeScan Scotland Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: February 5, 2019
• Est. primary completion date: February 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• OneTouch Verio
OneTouch Verio Blood Glucose Monitoring System.
• OneTouch Select Plus
OneTouch Select Plus Blood Glucose Monitoring System.
• OneTouch Ultra
OneTouch Ultra Blood Glucose Monitoring System.

Locations

Country	Name	City	State
United Kingdom	MAC Clinical Research	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
LifeScan Scotland Ltd	MAC Clinical Research

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 (%).	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 (%).	Less than 30 minutes