Diabetic Mellitus Patients Glucose Range Awareness After Experiencing a New Blood Glucose Meter Feature
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus
Started Jul 2015
Shorter than P25 for not_applicable diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 9, 2015
CompletedFirst Posted
Study publicly available on registry
July 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedSeptember 14, 2016
September 1, 2016
1 month
July 9, 2015
September 12, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Success rate to categorize blood glucose values into accepted ranges.
On average within 30 mins post intervention.
Secondary Outcomes (1)
Actual time taken to categorize blood glucose values into accepted ranges on the questionnaire provided.
On average within 30 mins post intervention.
Study Arms (1)
Education with new meter feature.
EXPERIMENTALSubjects experience a computer stimulation of a new meter feature ( colour range indicator) to help subjects interpret whether blood glucose results are low, in-range or high based on accepted guidance.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Previous use of any blood glucose meter with the colour range indicator feature to be evaluated in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LifeScanlead
Study Sites (1)
NHS Lothian
Edinburgh, EH16 4SA, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mike Grady, Phd
LifeScan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2015
First Posted
July 15, 2015
Study Start
July 1, 2015
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
September 14, 2016
Record last verified: 2016-09