Diabetes Mellitus
Conditions
Brief summary
To investigate whether novel insight features in new BGMs can improve glycemic control.
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
Sponsors
LifeScan
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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or planning pregnancy within duration of study or breast feeding; subjects who become pregnant during the study will be withdrawn * Conflict of Interest
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A1c change from baseline after 12 weeks | 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. |
Countries
United Kingdom
Outcome results
None listed