User Performance and System Accuracy Evaluations Using Glucose Adjustment

Not Applicable

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Device: Blood Glucose Monitoring Systems.

• Registration Number: NCT02374879
• Lead Sponsor: LifeScan

Brief Summary

This is an open-label, non-randomised pilot study, to evaluate user performance and system accuracy in blood Glucose monitoring system with glucose adjustment. Twelve male and female volunteers aged 18-45, with a documented diagnosis of Type I diabetes for at least 12 will be enrolled in this study.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-01
• Primary Completion: 2015-02-01
• Study Completion: 2015-02-01
• Study First Submitted: 2015-02-18
• Study First Submitted QC: 2015-02-24
• Study First Posted: 2015-03-02
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-14
• Last Update Posted: 2017-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blood Glucose monitoring System (BGMS)	Blood Glucose Monitoring Systems.	Intervention: Blood Glucose monitoring System (BGMS) Results obtained from the BGMS for UP and SA are compared to a reference instrument (YSI)

Primary Outcome Measures

Name	Time	Method
User Performance (UP) evaluation.	Up to 6 hours	UP evaluation of blood glucose monitoring systems compared to a reference instrument. Samples collected by subject and HCP
System Accuracy (SA) evaluation	Up to 6 hours	UP evaluation of blood glucose monitoring systems compared to a reference instrument. Samples collected by HCP only.

Trial Locations

Locations (1)

BioKinetic Europe Ltd; 🇬🇧 Belfast, Antrim, United Kingdom