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Assessment of Blood Glucose Monitoring Devices With New Insight Features

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02929654
Recruitment Status : Completed
First Posted : October 11, 2016
Last Update Posted : August 15, 2017
Sponsor:
Information provided by (Responsible Party):
LifeScan

Study Description
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Brief Summary:
To investigate whether novel insight features in new BGMs can improve glycemic control.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Device: OneTouch Verio® Device: OneTouch Verio® Flex Device: Subject's Own Blood Glucose Meter Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 267 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Other
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : June 22, 2017
Actual Study Completion Date : June 22, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02929654


Locations
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United Kingdom
Diabetes Centre, Heartlands Hospital
Birmingham, United Kingdom, B9 5SS
NHS Lothian
Edinburgh, United Kingdom, EH16 4SA
Highland Diabetes Institute
Inverness, United Kingdom, IV2 3JH
Sponsors and Collaborators
LifeScan
Investigators
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Study Director: Mike Grady LifeScan Scotland
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: LifeScan
ClinicalTrials.gov Identifier: NCT02929654    
Other Study ID Numbers: 3150067
First Posted: October 11, 2016    Key Record Dates
Last Update Posted: August 15, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No