An observational study in Diabetes, sponsored by Ascensia Diabetes Care. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-29.
Sponsored by Ascensia Diabetes Care · Observational
The purpose of this study is to evaluate a diabetes data management program in the hands of potential users, both health care professionals and lay users.
Diabetes data management programs analyze blood glucose results downloaded from glucose meters to assist health care professionals or lay users manage their diabetes. During the study, subjects download meters, generate and print reports, evaluate the program's ease of use, and verify that they understand the program output.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 51 is below the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Ascensia Diabetes Care is the lead sponsor of 42 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Lay users males or females and health care professionals.
Health Care Professionals:
Lay users must:
Exclusion Criteria:
h= 8 health care professionals p= 43 lay users
Number of Participants That Rated 80% of Tasks as Very Simple, Simple, or Neither Simple Nor Difficult (Ease of Use of the Software Program)
After completing each task, subjects rated the ease of performing each task on a scale of 1 to 5. 1. Very Simple 2. Simple 3. Neither simple nor difficult 4. Difficult 5. Very Difficult Outcome measure was the number of participants that rated 80% of tasks as 1,2, or 3.
Time frame: 1-2 hours
Number of Participants Rated as <= 3 (Success in Using the Program)
Subjects were rated by study staff as to their success at performing basic tasks. The rating scale was: 1. successful 2. successful after being referred to user instructions 3. success with assistance (similar to a customer call) 4. unsuccessful 5 = software problem Outcome measure was the number of participants rated as \<= 3.
Time frame: 1-2 hours
Number of Participants That Could Answer at Least 85% of the Comprehension Questions Correctly (Comprehension of the Program Reports)
Subjects were asked thirty questions throughout the evaluation to test whether they understood the data displays, graphs and features of the software. Outcome measure was the number of participants that could answer at least 85% of the comprehension questions correctly.
Time frame: 1-2 hours
| Milestone | Health Care Professionals and Lay Users |
|---|---|
| Started | 51 |
| Completed | 51 |
| Not completed | 0 |
After completing each task, subjects rated the ease of performing each task on a scale of 1 to 5. 1. Very Simple 2. Simple 3. Neither simple nor difficult 4. Difficult 5. Very Difficult Outcome measure was the number of participants that rated 80% of tasks as 1,2, or 3.
| Participants | Health Care Professionals and Lay Users |
|---|---|
| Number of Participants That Rated 80% of Tasks as Very Simple, Simple, or Neither Simple Nor Difficult (Ease of Use of the Software Program) | 46 |
Subjects were rated by study staff as to their success at performing basic tasks. The rating scale was: 1. successful 2. successful after being referred to user instructions 3. success with assistance (similar to a customer call) 4. unsuccessful 5 = software problem Outcome measure was the number of participants rated as \<= 3.
| Participants | Health Care Professionals and Lay Users |
|---|---|
| Number of Participants Rated as <= 3 (Success in Using the Program) | 50 |
Subjects were asked thirty questions throughout the evaluation to test whether they understood the data displays, graphs and features of the software. Outcome measure was the number of participants that could answer at least 85% of the comprehension questions correctly.
| participants | Health Care Professionals and Lay Users |
|---|---|
| Number of Participants That Could Answer at Least 85% of the Comprehension Questions Correctly (Comprehension of the Program Reports) | 50 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Health Care Professionals and Lay Users | — | 0/51 (0%) | 0/51 (0%) |
| Age, Continuous(years) | Health Care Professionals and Lay Users |
|---|---|
| Median | 53 (18 to 82) |
| Sex: Female, Male(Participants) | Health Care Professionals and Lay Users |
|---|---|
| Female | 29 |
| Male | 22 |
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Ascensia Diabetes Care