Assessment of Blood Glucose Monitoring Devices With New Insight Features

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

Completed

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diabetes Centre, Heartlands Hospital, Birmingham, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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planning pregnancy within duration of study or breast feeding; subjects who become pregnant during the study will be withdrawn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

Treatment and study plan

OneTouch Verio®

Device

Colour Enhanced Blood Glucose Meter.

OneTouch Verio® Flex

Device

Colour Enhanced Blood Glucose Meter.

Subject's Own Blood Glucose Meter

Device

Subject's Own Blood Glucose Meter

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

LifeScan

Industry

Registry information

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Oct 11, 2016
Registry last updated: Aug 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed