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NCT02498054 Clinical Trial

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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02498054
Other study ID # 3135718
Secondary ID
Status Completed
Phase N/A
First received July 9, 2015
Last updated September 12, 2016
Start date July 2015
Est. completion date August 2015

Study information
Verified date September 2016
Source LifeScan
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Behavioral:
• Education with new meter feature.
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).

Locations
Country Name City State
United Kingdom NHS Lothian Edinburgh

Sponsors (1)
Lead Sponsor Collaborator
LifeScan

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Success rate to categorize blood glucose values into accepted ranges. On average within 30 mins post intervention. No
Secondary Actual time taken to categorize blood glucose values into accepted ranges on the questionnaire provided. On average within 30 mins post intervention. No
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