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NCT02929654 Clinical Trial

Assessment of Blood Glucose Monitoring Devices With New Insight Features

Diabetes Mellitus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02929654
Other study ID # 3150067
Secondary ID
Status Completed
Phase N/A
First received October 7, 2016
Last updated August 14, 2017
Start date October 1, 2016
Est. completion date June 22, 2017

Study information
Verified date August 2017
Source LifeScan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 267
Est. completion date June 22, 2017
Est. primary completion date June 22, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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or planning pregnancy within duration of study or breast feeding; subjects who become pregnant during the study will be withdrawn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 Design

Related Conditions & MeSH terms

Intervention

Device:
• OneTouch Verio®
Colour Enhanced Blood Glucose Meter.
• OneTouch Verio® Flex
Colour Enhanced Blood Glucose Meter.
• Subject's Own Blood Glucose Meter
Subject's Own Blood Glucose Meter

Locations
Country Name City State
United Kingdom Diabetes Centre, Heartlands Hospital Birmingham
United Kingdom NHS Lothian Edinburgh
United Kingdom Highland Diabetes Institute Inverness

Sponsors (1)
Lead Sponsor Collaborator
LifeScan

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 12 weeks
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