Diabetes Mellitus
Conditions
Brief summary
The purpose of this study is to evaluate a Diabetes management program in the hands of potential users, both health care professionals and lay persons.
Detailed description
Diabetes data management programs upload glucose meter results to computers to provide information at home to lay people with diabetes and their healthcare professionals to manage their diabetes. The study evaluated the subjects' success using the software program with a blood glucose meter to perform specific tasks, such as uploading the meter results, changing program and meter settings, and displaying reports. The study also evaluated the system's ease of use and the acceptability of product labeling.
Interventions
DEVICEGLUCOFACTS® Deluxe
Diabetes Data Management Software
Sponsors
Ascensia Diabetes Care
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Lay users must: * Be at least 18 years of age (at least 80% must be 55 years or less) * Have diabetes or be the parent or legal guardian of a child with diabetes who routinely test their blood sugar at home * Be testing blood sugar at home at least twice daily for at least one month or be the parent or legal guardian of a child who has been testing blood sugar at home at least twice daily for at least one month * Be able to speak, read, and understand English * Have experience using PC programs or browsing the internet * Have utilized diabetes management software at home in the last year (at least 75% of lay users) or be familiar with diabetes management software HCPs must: * Have experience using diabetes data management software in the medical office or assist in patients' diabetes disease management using software
Exclusion criteria
* Person working for a competitive medical device company * Person having a cognitive disorder or condition which, in the opinion of the investigator, would put the person at risk or compromise the integrity of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Rated Successful (<=3) at Performing Specific Tasks | 1-2 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3 | 1-2 hours | 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 |
| Number of Participants Who Rated Clarity and Usefulness of User Instructions as >=3 | 1-2 hours | 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 |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Intended Users of the Software Baseline measures apply to lay persons (n=40) not healthcare professionals in the study. | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Intended Users of the Software |
|---|---|
| Age, Customized | 36 years |
| Region of Enrollment United States | 40 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 51 |
| serious Total, serious adverse events | 0 / 51 |
Outcome results
Primary
Number of Participants Rated Successful (<=3) at Performing Specific Tasks
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
Time frame: 1-2 hours
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intended Users of the Software | Number of Participants Rated Successful (<=3) at Performing Specific Tasks | Start Glucofacts® Deluxe | 50 participants |
| Intended Users of the Software | Number of Participants Rated Successful (<=3) at Performing Specific Tasks | Set up Patient Profile (New User) | 50 participants |
| Intended Users of the Software | Number of Participants Rated Successful (<=3) at Performing Specific Tasks | Download CONTOUR meter | 50 participants |
| Intended Users of the Software | Number of Participants Rated Successful (<=3) at Performing Specific Tasks | Display the 'standard day' report | 50 participants |
| Intended Users of the Software | Number of Participants Rated Successful (<=3) at Performing Specific Tasks | Display the logbook | 50 participants |
| Intended Users of the Software | Number of Participants Rated Successful (<=3) at Performing Specific Tasks | Enter a Hemoglobin A1c result to the logbook | 50 participants |
| Intended Users of the Software | Number of Participants Rated Successful (<=3) at Performing Specific Tasks | Find A1c result in logbook | 50 participants |
| Intended Users of the Software | Number of Participants Rated Successful (<=3) at Performing Specific Tasks | Change Blood sugar (BS) ranges in the software | 50 participants |
| Intended Users of the Software | Number of Participants Rated Successful (<=3) at Performing Specific Tasks | Change personal BS ranges in the CONTOUR meter | 50 participants |
| Intended Users of the Software | Number of Participants Rated Successful (<=3) at Performing Specific Tasks | Change CONTOUR meter settings | 50 participants |
| Intended Users of the Software | Number of Participants Rated Successful (<=3) at Performing Specific Tasks | Download CONTOUR USB meter | 50 participants |
| Intended Users of the Software | Number of Participants Rated Successful (<=3) at Performing Specific Tasks | Display the 'Summary' report | 50 participants |
| Intended Users of the Software | Number of Participants Rated Successful (<=3) at Performing Specific Tasks | Change CONTOUR USB meter HI and LO settings | 50 participants |
| Intended Users of the Software | Number of Participants Rated Successful (<=3) at Performing Specific Tasks | Change CONTOUR USB meter trends length | 50 participants |
| Intended Users of the Software | Number of Participants Rated Successful (<=3) at Performing Specific Tasks | Change default BS ranges for patients (HCPs only) | 10 participants |
| Intended Users of the Software | Number of Participants Rated Successful (<=3) at Performing Specific Tasks | Find patient in database / view data (HCPs only) | 10 participants |
Secondary
Number of Participants Who Rated Clarity and Usefulness of User Instructions as >=3
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
Time frame: 1-2 hours
Population: Some subjects had no opinion; the number of subjects that did respond with ratings are identified in parentheses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intended Users of the Software | Number of Participants Who Rated Clarity and Usefulness of User Instructions as >=3 | Clarity of instructions in User Guide (n=33) | 33 participants |
| Intended Users of the Software | Number of Participants Who Rated Clarity and Usefulness of User Instructions as >=3 | Clarity-instruct in Quick Reference Guide (n=35) | 35 participants |
| Intended Users of the Software | Number of Participants Who Rated Clarity and Usefulness of User Instructions as >=3 | Clarity of the online help (n=35) | 31 participants |
| Intended Users of the Software | Number of Participants Who Rated Clarity and Usefulness of User Instructions as >=3 | Usefulness of instructions in User Guide (n=30) | 30 participants |
| Intended Users of the Software | Number of Participants Who Rated Clarity and Usefulness of User Instructions as >=3 | Usefulness-instructions Quick Reference Guide(33) | 33 participants |
| Intended Users of the Software | Number of Participants Who Rated Clarity and Usefulness of User Instructions as >=3 | Usefulness of the online help (n=31) | 29 participants |
Secondary
Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3
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
Time frame: 1-2 hours
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intended Users of the Software | Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3 | Start Glucofacts® Deluxe | 100 percentage of participants |
| Intended Users of the Software | Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3 | Set up Patient Profile (New User) | 100 percentage of participants |
| Intended Users of the Software | Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3 | Download CONTOUR meter | 100 percentage of participants |
| Intended Users of the Software | Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3 | Display the 'standard day' report | 98 percentage of participants |
| Intended Users of the Software | Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3 | Display the logbook | 100 percentage of participants |
| Intended Users of the Software | Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3 | Enter a Hemoglobin A1c result to the logbook | 90 percentage of participants |
| Intended Users of the Software | Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3 | Find A1c result in logbook | 88 percentage of participants |
| Intended Users of the Software | Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3 | Change Blood sugar (BS) ranges in the software | 92 percentage of participants |
| Intended Users of the Software | Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3 | Change personal BS ranges in the CONTOUR meter | 98 percentage of participants |
| Intended Users of the Software | Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3 | Change CONTOUR meter settings | 98 percentage of participants |
| Intended Users of the Software | Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3 | Download CONTOUR USB meter | 96 percentage of participants |
| Intended Users of the Software | Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3 | Display the 'Summary' report | 100 percentage of participants |
| Intended Users of the Software | Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3 | Change CONTOUR USB meter HI and LO settings | 96 percentage of participants |
| Intended Users of the Software | Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3 | Change CONTOUR USB meter trends length | 98 percentage of participants |
| Intended Users of the Software | Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3 | Change default BS ranges for patients (HCPs only) | 90 percentage of participants |
| Intended Users of the Software | Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3 | Find patient in database / view data (HCPs only) | 90 percentage of participants |