Diabetic Mellitus Patients Glucose Range Awareness After Experiencing a New Blood Glucose Meter Feature

A single visit & single arm study in 80 subjects with diabetes to determine if a short educational experience with a new blood glucose meter feature improves the ability of each subject to better classify glucose results into acceptable glucose ranges.

Completed

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Key information

Conditions

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

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NHS Lothian

Edinburgh, EH16 4SA, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Diagnosed with Type 1 diabetes Mellitus (T1DM) or Type 2 diabetes Mellitus (T2DM) for ≥ 3 months
Currently performing self monitoring of blood glucose (SMBG) at home
Aged ≥16 years

Exclusion criteria

Previous use of any blood glucose meter with the colour range indicator feature to be evaluated in this study.

Treatment and study plan

Education with new meter feature.

Behavioral

The blood glucose meter has default settings for the colour range indicator which can be customized by the subjects and/or their healthcare professional. This colour range indicator will be presented to the subjects as a computer simulation to show subjects a range of typical blood glucose values and how this new feature would classify these results as being low (blue), in-range (green) or high (red).

Primary outcomes

Success rate to categorize blood glucose values into accepted ranges.

Time frame: On average within 30 mins post intervention.

Secondary outcomes

Actual time taken to categorize blood glucose values into accepted ranges on the questionnaire provided.

Time frame: On average within 30 mins post intervention.

Sponsors and collaborators

Lead sponsor

LifeScan

Industry

Registry information

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Jul 15, 2015
Registry last updated: Sep 14, 2016

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.

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Completed