Blood glucose performance test

Not Applicable

• Conditions: Nutritional, Metabolic, Endocrine; Diabetes mellitus

• Registration Number: ISRCTN11379850
• Lead Sponsor: Abbott Diabetes Care Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-12
• Last Update Posted: 20 July 2020
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

1. Diagnosed with diabetes
2. =16 years of age

Exclusion Criteria

1. Participated in the study event already
2. Member of the site study team

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. The accuracy of the blood glucose monitoring system compared to the YSI analyser using fingerstick capillary or venous whole blood samples:<br> 1.1. Capillary: Percentage of replicates within ISO15197 2003 or 2015 system accuracy criteria<br> 1.2. Venous: Percentage of responses within each zone of the Consensus Error Grid<br> Measured at the single study visit<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Precision: Mean paired replicate coefficient of variation (Capillary/Venous)<br> 2. Error grid analysis: Percentage of replicates within each zone of the Consensus Error Grid (Capillary)<br> Measured at the single study visit<br>