Assessment of Blood Glucose Monitoring Devices With New Insight Features

August 14, 2017 updated by: LifeScan
To investigate whether novel insight features in new BGMs can improve glycemic control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

267

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria Summary:

  • 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 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or planning pregnancy within duration of study or breast feeding; subjects who become pregnant during the study will be withdrawn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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Subject continue to use their own Blood Glucose Monitoring System ( BGMS) for 12 weeks.
Device: Subject's Own Blood Glucose Meter
Subject's Own Blood Glucose Meter
Experimental: OneTouch Verio®
Subjects use LifeScan provided BGMS (OneTouch Verio®) for 12 weeks
Device: OneTouch Verio®
Colour Enhanced Blood Glucose Meter.
Experimental: Intervention 02
Subjects use LifeScan provided BGMS (OneTouch Verio® Flex ) for 12 weeks.
Device: OneTouch Verio® Flex
Colour Enhanced Blood Glucose Meter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A1c change from baseline after 12 weeks
Time Frame: 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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LifeScan

Investigators

  • Study Director: Mike Grady, LifeScan Scotland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

June 22, 2017

Study Completion (Actual)

June 22, 2017

Study Registration Dates

First Submitted

October 7, 2016

First Submitted That Met QC Criteria

October 7, 2016

First Posted (Estimate)

October 11, 2016

Study Record Updates

Last Update Posted (Actual)

August 15, 2017

Last Update Submitted That Met QC Criteria

August 14, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 3150067

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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