Assessment of Blood Glucose Monitoring Devices With New Insight Features

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Device: OneTouch Verio® Flex; Device: OneTouch Verio®; Device: Subject's Own Blood Glucose Meter

• Registration Number: NCT02929654
• Lead Sponsor: LifeScan

Brief Summary

To investigate whether novel insight features in new BGMs can improve glycemic control.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-01
• Study First Submitted: 2016-10-07
• Study First Submitted QC: 2016-10-07
• Study First Posted: 2016-10-11
• Primary Completion: 2017-06-22
• Study Completion: 2017-06-22
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-14
• Last Update Posted: 2017-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 267

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Intervention 02	OneTouch Verio® Flex	Subjects use LifeScan provided BGMS (OneTouch Verio® Flex ) for 12 weeks.
OneTouch Verio®	OneTouch Verio®	Subjects use LifeScan provided BGMS (OneTouch Verio®) for 12 weeks
Control	Subject's Own Blood Glucose Meter	Subject continue to use their own Blood Glucose Monitoring System ( BGMS) for 12 weeks.

Primary Outcome Measures

Name	Time	Method
A1c change from baseline after 12 weeks	12 weeks	A1c change from baseline after 12 weeks in subjects using BGMs with color range indicator and/or pattern messaging tools (i.e., OneTouch Verio® Flex and OneTouch Verio® combined) compared to subjects with either T1 or T2DM using their current BGM, i.e., without color range indicator and/or pattern messaging tools.

Trial Locations

Locations (3)

Diabetes Centre, Heartlands Hospital; 🇬🇧 Birmingham, United Kingdom

Highland Diabetes Institute; 🇬🇧 Inverness, United Kingdom

NHS Lothian; 🇬🇧 Edinburgh, United Kingdom