ClinicalTrials.gg
CompletedNCT02929654Updated Aug 15, 2017

Assessment of Blood Glucose Monitoring Devices With New Insight Features

An interventional study of OneTouch Verio® and OneTouch Verio® Flex in Diabetes Mellitus, sponsored by LifeScan. Completed at 3 sites in United Kingdom. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-08-15.

Sponsored by LifeScan (formerly part of Johnson & Johnson) · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
267
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Diabetes Mellitus

Browse trials for

03

In context

Diabetes Mellitus

11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 267 is above the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

LifeScan is the lead sponsor of 15 studies on the registry; none are open to participants now.

First submitted before LifeScan left Johnson & Johnson.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosed with T1DM or T2DM for ≥ 3 month prior to screening
  • Currently performing SMBG at home for diabetes management decisions
  • Willingness to notify the study staff if they become pregnant during the study
  • Willing to sign an informed consent

Exclusion criteria

Exclusion Criteria Summary:

  • Is unlikely to be compliant with the diabetes regimen in the opinion of study staff
  • Currently pregnant or planning pregnancy within duration of study or breast feeding; subjects who become pregnant during the study will be withdrawn
  • Conflict of Interest
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
267 participants (estimated)

Study arms

  • Active comparator
    Control

    Subject continue to use their own Blood Glucose Monitoring System ( BGMS) for 12 weeks.

    Device: Subject's Own Blood Glucose Meter

  • Experimental
    OneTouch Verio®

    Subjects use LifeScan provided BGMS (OneTouch Verio®) for 12 weeks

    Device: OneTouch Verio®

  • Experimental
    Intervention 02

    Subjects use LifeScan provided BGMS (OneTouch Verio® Flex ) for 12 weeks.

    Device: OneTouch Verio® Flex

Interventions

  • DeviceOneTouch Verio®

    Colour Enhanced Blood Glucose Meter.

  • DeviceOneTouch Verio® Flex

    Colour Enhanced Blood Glucose Meter.

  • DeviceSubject's Own Blood Glucose Meter

    Subject's Own Blood Glucose Meter

06

What researchers measure

Primary outcomes

  1. A1c change from baseline after 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.

    Time frame: 12 weeks

07

Study locations

3 sites
  • Diabetes Centre, Heartlands Hospital
    Birmingham, B9 5SS, United Kingdom
  • NHS Lothian
    Edinburgh, EH16 4SA, United Kingdom
  • Highland Diabetes Institute
    Inverness, IV2 3JH, United Kingdom
08

References and documents

Publications

  • Grady M, Katz LB, Levy BL. Use of Blood Glucose Meters Featuring Color Range Indicators Improves Glycemic Control in Patients With Diabetes in Comparison to Blood Glucose Meters Without Color (ACCENTS Study). J Diabetes Sci Technol. 2018 Nov;12(6):1211-1219. doi: 10.1177/1932296818775755. Epub 2018 May 31. PubMed 29848106 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02929654
Lead sponsor
LifeScan
Responsible party
Sponsor
First posted
Oct 11, 2016
Start date
Oct 1, 2016
Primary completion
Jun 22, 2017
Completion
Jun 22, 2017
Last update
Aug 15, 2017

Study contacts

Mike Grady
study director · LifeScan Scotland

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion