Diabetes
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Ascensia Diabetes Care
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Health Care Professionals: 1. Must have experience using diabetes data management software in the medical office such as downloading meters, reviewing reports (computer screen or printouts), or assisting in patients' diabetes disease management using software. 2. May include: endocrinologists, primary care physicians, nurse educators, or other medical staff involved in downloading meters or interpreting the data output. * Lay users must: 1. Be at least 18 years of age. 2. Have diabetes (or be the parent or legal guardian of a child with diabetes) and have been testing blood sugar at home at least twice daily for one month or more. 3. Be able to speak, read and understand English. 4. Currently using diabetes management software at home or be familiar with diabetes management software. At least 75% of subjects must have been using software for at least one month. 5. Have experience using PC programs or browsing the internet.
Exclusion criteria
* Persons working for a competitive medical device company.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Rated 80% of Tasks as Very Simple, Simple, or Neither Simple Nor Difficult (Ease of Use of the Software Program) | 1-2 hours | 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. |
| Number of Participants Rated as <= 3 (Success in Using the Program) | 1-2 hours | 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. |
| Number of Participants That Could Answer at Least 85% of the Comprehension Questions Correctly (Comprehension of the Program Reports) | 1-2 hours | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Health Care Professionals and Lay Users h= 8 health care professionals p= 43 lay users | 51 |
| Total | 51 |
Baseline characteristics
| Characteristic | Health Care Professionals and Lay Users |
|---|---|
| Age, Continuous | 53 years |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 22 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 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Health Care Professionals and Lay Users | Number of Participants Rated as <= 3 (Success in Using the Program) | 50 Participants |
p-value: 0.0309Exact binomial test
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 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 participants |
p-value: 0.0309Exact binomial test
Primary
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
Population: per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 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 Participants |
p-value: 0.0421Exact binomial test