Diabetes
Conditions
Brief summary
The purpose of this study is to evaluate a Diabetes data management program in the hands of potential users, both lay persons and healthcare professionals. With this data management system glucose results from the DIDGET TM meter can be uploaded to a secure website and used by adults with diabetes, by parents and guardians of children with diabetes, and by health care professionals to monitor diabetes by recognizing trends and patterns in blood sugar levels.
Detailed description
Diabetes data management programs upload glucose meter results to computers to provide information to lay persons and their health care professionals. With this data management system glucose results from the DIDGET TM meter can be uploaded to a secure website and used by adults with diabetes, by parents and guardians of children with diabetes, and by health care professionals to monitor diabetes by recognizing trends and patterns in blood sugar levels. During the study subjects performed specific tasks, such as uploading meter results and displaying reports. The study evaluates the subjects' success in using the software program, the program's ease of use, clarity and usefulness of user instructions, and user satisfaction with the diabetes data management program.
Interventions
DEVICEDIDGET World Web Community Reports
During the study subjects performed specific tasks, such as uploading meter results to a secure website and displaying reports.
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 80 Years
Healthy volunteers
No
Inclusion criteria
* Lay users must be: 1. Be at least 18 years of age 2. Have diabetes or be the parent or legal guardian of a child with diabetes 3. 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 4. Be able to speak, read, and understand English 5. Have experience using a PC, navigating software programs, or browsing the internet * Healthcare professionals must: 1. Have experience using the internet 2. Have experience using diabetes data management software in the medical office
Exclusion criteria
1. Person working for a competitive medical device company 2. 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 Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks | 1-2 hours | Study staff rated participants on their success at performing specific tasks. The rating scale was: 1. = Successful ( no assistance) 2. = Successful after staff prompted to view user instructions 3. = Successful with verbal assistance or review of part of user instructions (as review a specific function during a Customer Service call) 4. = Unsuccessful (Subject could not perform the task) 5. = Subject could not perform task due to software or hardware failure after repeated attempt. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Rated Ease of Performing Specific Tasks as Very Simple to Neither Simple Nor Difficult (<=3 Rating) | 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 Good to Excellent (>=3) | 1-2 hours | After the software evaluation, subjects were asked to review the online help and rate it on a 5 point scale. 1. = Unacceptable 2. = Poor 3. = Good 4. = Very Good 5. = Excellent |
| Number of Participants Who Rated Their Satisfaction With The Following as Good to Excellent (>=3) | 1-2 hours | Subjects responded to questionnaires in rating features and appearance, usefulness, and satisfaction on a 5 point scale: 1. = Unacceptable 2. = Poor 3. = Good 4. = Very Good 5. = Excellent |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intended Users of the Software Baseline measures were analyzed using only data for the young adults (18-24 years of age) and parents/guardians (18 to 47 years of age) of children with diabetes, not healthcare professionals. Data was not used from one subject withdrawn from the study because the subject did not meet inclusion criteria. | 47 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not meet inclusion criteria | 1 |
Baseline characteristics
| Characteristic | Intended Users of the Software |
|---|---|
| Age, Continuous | 26.9 years |
| Region of Enrollment United States | 47 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
Primary
Number of Participants Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks
Study staff rated participants on their success at performing specific tasks. The rating scale was: 1. = Successful ( no assistance) 2. = Successful after staff prompted to view user instructions 3. = Successful with verbal assistance or review of part of user instructions (as review a specific function during a Customer Service call) 4. = Unsuccessful (Subject could not perform the task) 5. = Subject could not perform task due to software or hardware failure after repeated attempt.
Time frame: 1-2 hours
Population: One subject was withdrawn from the study and the data was not used in the analysis. The subject did not meet inclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intended Users of the Software | Number of Participants Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks | Log in to DIDGET World Reports | 50 participants |
| Intended Users of the Software | Number of Participants Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks | Upload DIDGET Meter | 50 participants |
| Intended Users of the Software | Number of Participants Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks | Accept DIDGET meter settings | 50 participants |
| Intended Users of the Software | Number of Participants Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks | Display Blood Sugar Trend Report | 50 participants |
| Intended Users of the Software | Number of Participants Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks | Display the Standard Day Report | 50 participants |
| Intended Users of the Software | Number of Participants Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks | Change Daily Time Periods | 49 participants |
| Intended Users of the Software | Number of Participants Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks | Display the Logbook | 50 participants |
| Intended Users of the Software | Number of Participants Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks | Display the Standard Week Report | 50 participants |
| Intended Users of the Software | Number of Participants Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks | Identify Out of Target Results | 50 participants |
| Intended Users of the Software | Number of Participants Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks | Print the Standard Day and Standard Week Reports | 50 participants |
| Intended Users of the Software | Number of Participants Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks | Display the Summary Report | 50 participants |
| Intended Users of the Software | Number of Participants Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks | Save Summary Reports as a file on your computer | 50 participants |
| Intended Users of the Software | Number of Participants Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks | Change Low and High Blood Sugar Ranges in Reports | 50 participants |
| Intended Users of the Software | Number of Participants Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks | Log out of Web Reports | 48 participants |
Secondary
Number of Participants Who Rated Clarity and Usefulness of User Instructions as Good to Excellent (>=3)
After the software evaluation, subjects were asked to review the online help and rate it on a 5 point scale. 1. = Unacceptable 2. = Poor 3. = Good 4. = Very Good 5. = Excellent
Time frame: 1-2 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intended Users of the Software | Number of Participants Who Rated Clarity and Usefulness of User Instructions as Good to Excellent (>=3) | Clarity of online help | 49 participants |
| Intended Users of the Software | Number of Participants Who Rated Clarity and Usefulness of User Instructions as Good to Excellent (>=3) | Usefulness of online help | 47 participants |
Secondary
Number of Participants Who Rated Ease of Performing Specific Tasks as Very Simple to Neither Simple Nor Difficult (<=3 Rating)
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: One subject was withdrawn from the study and the data was not used in the analysis. The subject did not meet inclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intended Users of the Software | Number of Participants Who Rated Ease of Performing Specific Tasks as Very Simple to Neither Simple Nor Difficult (<=3 Rating) | Log in to DIDGET World Reports | 50 participants |
| Intended Users of the Software | Number of Participants Who Rated Ease of Performing Specific Tasks as Very Simple to Neither Simple Nor Difficult (<=3 Rating) | Upload DIDGET Meter | 50 participants |
| Intended Users of the Software | Number of Participants Who Rated Ease of Performing Specific Tasks as Very Simple to Neither Simple Nor Difficult (<=3 Rating) | Accept DIDGET meter settings | 50 participants |
| Intended Users of the Software | Number of Participants Who Rated Ease of Performing Specific Tasks as Very Simple to Neither Simple Nor Difficult (<=3 Rating) | Display Blood Sugar Trend Report | 50 participants |
| Intended Users of the Software | Number of Participants Who Rated Ease of Performing Specific Tasks as Very Simple to Neither Simple Nor Difficult (<=3 Rating) | Display the Standard Day Report | 50 participants |
| Intended Users of the Software | Number of Participants Who Rated Ease of Performing Specific Tasks as Very Simple to Neither Simple Nor Difficult (<=3 Rating) | Change Daily Time Periods | 40 participants |
| Intended Users of the Software | Number of Participants Who Rated Ease of Performing Specific Tasks as Very Simple to Neither Simple Nor Difficult (<=3 Rating) | Display the Logbook | 49 participants |
| Intended Users of the Software | Number of Participants Who Rated Ease of Performing Specific Tasks as Very Simple to Neither Simple Nor Difficult (<=3 Rating) | Display the Standard Week Report | 50 participants |
| Intended Users of the Software | Number of Participants Who Rated Ease of Performing Specific Tasks as Very Simple to Neither Simple Nor Difficult (<=3 Rating) | Identify Out of Target Results | 50 participants |
| Intended Users of the Software | Number of Participants Who Rated Ease of Performing Specific Tasks as Very Simple to Neither Simple Nor Difficult (<=3 Rating) | Print the Standard Day and Standard Week Reports | 50 participants |
| Intended Users of the Software | Number of Participants Who Rated Ease of Performing Specific Tasks as Very Simple to Neither Simple Nor Difficult (<=3 Rating) | Display the Summary Report | 50 participants |
| Intended Users of the Software | Number of Participants Who Rated Ease of Performing Specific Tasks as Very Simple to Neither Simple Nor Difficult (<=3 Rating) | Save Summary Reports as a file on your computer | 48 participants |
| Intended Users of the Software | Number of Participants Who Rated Ease of Performing Specific Tasks as Very Simple to Neither Simple Nor Difficult (<=3 Rating) | Change Low and High Blood Sugar Ranges in Reports | 49 participants |
| Intended Users of the Software | Number of Participants Who Rated Ease of Performing Specific Tasks as Very Simple to Neither Simple Nor Difficult (<=3 Rating) | Log out of Web Reports | 49 participants |
Secondary
Number of Participants Who Rated Their Satisfaction With The Following as Good to Excellent (>=3)
Subjects responded to questionnaires in rating features and appearance, usefulness, and satisfaction on a 5 point scale: 1. = Unacceptable 2. = Poor 3. = Good 4. = Very Good 5. = Excellent
Time frame: 1-2 hours
Population: One subject was withdrawn from the study and the data was not used in the analysis. The subject did not meet inclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intended Users of the Software | Number of Participants Who Rated Their Satisfaction With The Following as Good to Excellent (>=3) | Overall, the ease of use of DIDGET World Reports | 49 participants |
| Intended Users of the Software | Number of Participants Who Rated Their Satisfaction With The Following as Good to Excellent (>=3) | Ease of getting started | 50 participants |
| Intended Users of the Software | Number of Participants Who Rated Their Satisfaction With The Following as Good to Excellent (>=3) | Readability of computer display | 49 participants |
| Intended Users of the Software | Number of Participants Who Rated Their Satisfaction With The Following as Good to Excellent (>=3) | Usefulness of Log Book Report | 50 participants |
| Intended Users of the Software | Number of Participants Who Rated Their Satisfaction With The Following as Good to Excellent (>=3) | Usefulness of Blood Sugar Trend Graph | 50 participants |
| Intended Users of the Software | Number of Participants Who Rated Their Satisfaction With The Following as Good to Excellent (>=3) | Usefulness of Standard Day Graph | 50 participants |
| Intended Users of the Software | Number of Participants Who Rated Their Satisfaction With The Following as Good to Excellent (>=3) | Usefulness of Standard Week Graph | 50 participants |
| Intended Users of the Software | Number of Participants Who Rated Their Satisfaction With The Following as Good to Excellent (>=3) | Usefulness of Summary Either Bar Or Pie Chart | 50 participants |
| Intended Users of the Software | Number of Participants Who Rated Their Satisfaction With The Following as Good to Excellent (>=3) | Overall, type of information software gives me is | 50 participants |