Trial Outcomes & Findings for Evaluation of GLUCOFACTS® Deluxe Diabetes Management System (NCT NCT00892151)
NCT ID: NCT00892151
Last Updated: 2016-02-29
Results Overview
Study staff rated participants on their success at perfoming specific tasks. The rating scale was: 1. = Successful 2. = Successful after being referred to user instructions 3. = Successful with verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.) 4. = Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.) 5. = Problem encountered with software
COMPLETED
NA
51 participants
1-2 hours
2016-02-29
Participant Flow
One subject was withdrawn for non-compliance. The subject was a parent of a child with diabetes and the 17 year old child was performing the software evaluation instead of the parent. The protocol states that the subjects were to be 18 years and older. The subject was withdrawn from the study and the data was not used in the analysis.
Participant milestones
| Measure |
Intended Users of the Software
10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) used a diabetes data management program.
|
|---|---|
|
Overall Study
STARTED
|
51
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Intended Users of the Software
10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) used a diabetes data management program.
|
|---|---|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
Evaluation of GLUCOFACTS® Deluxe Diabetes Management System
Baseline characteristics by cohort
| Measure |
Intended Users of the Software
n=40 Participants
Baseline measures apply to lay persons (n=40) not healthcare professionals in the study.
|
|---|---|
|
Age, Customized
|
36 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1-2 hoursPopulation: Note: 2 tasks were performed only by the 10 healthcare professionals. Also, one lay person was withdrawn (leaving 50 participants). The subject was a parent of a child with diabetes;the 17 year old child performed the software evaluation instead of the parent. Data for the subject withdrawn from the study was not used in the analysis.
Study staff rated participants on their success at perfoming specific tasks. The rating scale was: 1. = Successful 2. = Successful after being referred to user instructions 3. = Successful with verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.) 4. = Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.) 5. = Problem encountered with software
Outcome measures
| Measure |
Intended Users of the Software
n=50 Participants
10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) used a diabetes data management program.
|
|---|---|
|
Number of Participants Rated Successful (<=3) at Performing Specific Tasks
Start Glucofacts® Deluxe
|
50 participants
|
|
Number of Participants Rated Successful (<=3) at Performing Specific Tasks
Set up Patient Profile (New User)
|
50 participants
|
|
Number of Participants Rated Successful (<=3) at Performing Specific Tasks
Download CONTOUR meter
|
50 participants
|
|
Number of Participants Rated Successful (<=3) at Performing Specific Tasks
Display the 'standard day' report
|
50 participants
|
|
Number of Participants Rated Successful (<=3) at Performing Specific Tasks
Display the logbook
|
50 participants
|
|
Number of Participants Rated Successful (<=3) at Performing Specific Tasks
Enter a Hemoglobin A1c result to the logbook
|
50 participants
|
|
Number of Participants Rated Successful (<=3) at Performing Specific Tasks
Find A1c result in logbook
|
50 participants
|
|
Number of Participants Rated Successful (<=3) at Performing Specific Tasks
Change Blood sugar (BS) ranges in the software
|
50 participants
|
|
Number of Participants Rated Successful (<=3) at Performing Specific Tasks
Change personal BS ranges in the CONTOUR meter
|
50 participants
|
|
Number of Participants Rated Successful (<=3) at Performing Specific Tasks
Change CONTOUR meter settings
|
50 participants
|
|
Number of Participants Rated Successful (<=3) at Performing Specific Tasks
Download CONTOUR USB meter
|
50 participants
|
|
Number of Participants Rated Successful (<=3) at Performing Specific Tasks
Display the 'Summary' report
|
50 participants
|
|
Number of Participants Rated Successful (<=3) at Performing Specific Tasks
Change CONTOUR USB meter HI and LO settings
|
50 participants
|
|
Number of Participants Rated Successful (<=3) at Performing Specific Tasks
Change CONTOUR USB meter trends length
|
50 participants
|
|
Number of Participants Rated Successful (<=3) at Performing Specific Tasks
Change default BS ranges for patients (HCPs only)
|
10 participants
|
|
Number of Participants Rated Successful (<=3) at Performing Specific Tasks
Find patient in database / view data (HCPs only)
|
10 participants
|
SECONDARY outcome
Timeframe: 1-2 hoursPopulation: Note: 2 tasks were performed only by the 10 healthcare professionals. Also, one lay person was withdrawn (leaving 50 participants). The subject was a parent of a child with diabetes; the 17 year old child performed the software evaluation instead of the parent. Data for the subject withdrawn from the study was not used in the analysis.
Subjects rated ease of using the software with respect to specific tasks. The rating scale was: 1. = Very Simple 2. = Simple 3. = Neither Simple nor Difficult 4. = Difficult 5. = Very Difficult
Outcome measures
| Measure |
Intended Users of the Software
n=50 Participants
10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) used a diabetes data management program.
|
|---|---|
|
Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3
Start Glucofacts® Deluxe
|
100 percentage of participants
|
|
Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3
Set up Patient Profile (New User)
|
100 percentage of participants
|
|
Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3
Download CONTOUR meter
|
100 percentage of participants
|
|
Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3
Display the 'standard day' report
|
98 percentage of participants
|
|
Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3
Display the logbook
|
100 percentage of participants
|
|
Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3
Enter a Hemoglobin A1c result to the logbook
|
90 percentage of participants
|
|
Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3
Find A1c result in logbook
|
88 percentage of participants
|
|
Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3
Change Blood sugar (BS) ranges in the software
|
92 percentage of participants
|
|
Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3
Change personal BS ranges in the CONTOUR meter
|
98 percentage of participants
|
|
Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3
Change CONTOUR meter settings
|
98 percentage of participants
|
|
Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3
Download CONTOUR USB meter
|
96 percentage of participants
|
|
Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3
Display the 'Summary' report
|
100 percentage of participants
|
|
Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3
Change CONTOUR USB meter HI and LO settings
|
96 percentage of participants
|
|
Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3
Change CONTOUR USB meter trends length
|
98 percentage of participants
|
|
Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3
Change default BS ranges for patients (HCPs only)
|
90 percentage of participants
|
|
Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3
Find patient in database / view data (HCPs only)
|
90 percentage of participants
|
SECONDARY outcome
Timeframe: 1-2 hoursPopulation: Some subjects had no opinion; the number of subjects that did respond with ratings are identified in parentheses.
User instructions included online help, User Guide, and a Quick Reference Guide. Subjects rated their clarity and usefulness and the rating scale was: 1. = Unacceptable 2. = Poor 3. = Good 4. = Very Good 5. = Excellent
Outcome measures
| Measure |
Intended Users of the Software
n=50 Participants
10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) used a diabetes data management program.
|
|---|---|
|
Number of Participants Who Rated Clarity and Usefulness of User Instructions as >=3
Clarity of instructions in User Guide (n=33)
|
33 participants
|
|
Number of Participants Who Rated Clarity and Usefulness of User Instructions as >=3
Clarity-instruct in Quick Reference Guide (n=35)
|
35 participants
|
|
Number of Participants Who Rated Clarity and Usefulness of User Instructions as >=3
Clarity of the online help (n=35)
|
31 participants
|
|
Number of Participants Who Rated Clarity and Usefulness of User Instructions as >=3
Usefulness of instructions in User Guide (n=30)
|
30 participants
|
|
Number of Participants Who Rated Clarity and Usefulness of User Instructions as >=3
Usefulness-instructions Quick Reference Guide(33)
|
33 participants
|
|
Number of Participants Who Rated Clarity and Usefulness of User Instructions as >=3
Usefulness of the online help (n=31)
|
29 participants
|
Adverse Events
Intended Users of the Software
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Carmine Greene, Senior Clinical Research Scientist
Ascensia Diabetes Care
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60