Diabetes Mellitus
Conditions
Brief 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.
Interventions
BEHAVIORALEducation 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).
Sponsors
LifeScan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate to categorize blood glucose values into accepted ranges. | On average within 30 mins post intervention. |
Secondary
| Measure | Time frame |
|---|---|
| Actual time taken to categorize blood glucose values into accepted ranges on the questionnaire provided. | On average within 30 mins post intervention. |
Countries
United Kingdom
Outcome results
None listed