Trial Outcomes & Findings for Evaluation of DIDGET TM World Reports (NCT NCT00923975)
NCT ID: NCT00923975
Last Updated: 2024-09-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
1-2 hours
Results posted on
2024-09-23
Participant Flow
Participant milestones
| Measure |
Intended Users of the Software
35 young adults (age 18 to 24) with diabetes, 12 Parents/legal guardians of children with diabetes, and 3 healthcare professionals who work with this population 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
35 young adults (age 18 to 24) with diabetes, 12 Parents/legal guardians of children with diabetes, and 3 healthcare professionals who work with this population used a diabetes data management program.
|
|---|---|
|
Overall Study
Did not meet inclusion criteria
|
1
|
Baseline Characteristics
Evaluation of DIDGET TM World Reports
Baseline characteristics by cohort
| Measure |
Intended Users of the Software
n=47 Participants
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 Data was not used from one subject withdrawn from the study because the subject did not meet inclusion criteria.
|
|---|---|
|
Age, Continuous
|
26.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1-2 hoursPopulation: One subject was withdrawn from the study and the data was not used in the analysis. The subject did not meet inclusion criteria.
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.
Outcome measures
| Measure |
Intended Users of the Software
n=50 Participants
35 young adults (age 18 to 24) with diabetes, 12 Parents/legal guardians of children with diabetes, and 3 healthcare professionals who work with this population used a diabetes data management program.
|
|---|---|
|
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
|
|
Number of Participants Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks
Display the Summary Report
|
50 participants
|
|
Number of Participants Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks
Log in to DIDGET World Reports
|
50 participants
|
|
Number of Participants Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks
Upload DIDGET Meter
|
50 participants
|
|
Number of Participants Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks
Accept DIDGET meter settings
|
50 participants
|
|
Number of Participants Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks
Display Blood Sugar Trend Report
|
50 participants
|
|
Number of Participants Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks
Display the Standard Day Report
|
50 participants
|
|
Number of Participants Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks
Change Daily Time Periods
|
49 participants
|
|
Number of Participants Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks
Display the Logbook
|
50 participants
|
|
Number of Participants Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks
Display the Standard Week Report
|
50 participants
|
|
Number of Participants Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks
Identify Out of Target Results
|
50 participants
|
|
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
|
|
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
|
|
Number of Participants Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks
Log out of Web Reports
|
48 participants
|
SECONDARY outcome
Timeframe: 1-2 hoursPopulation: One subject was withdrawn from the study and the data was not used in the analysis. The subject did not meet inclusion criteria.
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
35 young adults (age 18 to 24) with diabetes, 12 Parents/legal guardians of children with diabetes, and 3 healthcare professionals who work with this population used a diabetes data management program.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: 1-2 hoursAfter 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
Outcome measures
| Measure |
Intended Users of the Software
n=50 Participants
35 young adults (age 18 to 24) with diabetes, 12 Parents/legal guardians of children with diabetes, and 3 healthcare professionals who work with this population used a diabetes data management program.
|
|---|---|
|
Number of Participants Who Rated Clarity and Usefulness of User Instructions as Good to Excellent (>=3)
Clarity of online help
|
49 participants
|
|
Number of Participants Who Rated Clarity and Usefulness of User Instructions as Good to Excellent (>=3)
Usefulness of online help
|
47 participants
|
SECONDARY outcome
Timeframe: 1-2 hoursPopulation: One subject was withdrawn from the study and the data was not used in the analysis. The subject did not meet inclusion criteria.
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
Outcome measures
| Measure |
Intended Users of the Software
n=50 Participants
35 young adults (age 18 to 24) with diabetes, 12 Parents/legal guardians of children with diabetes, and 3 healthcare professionals who work with this population used a diabetes data management program.
|
|---|---|
|
Number of Participants Who Rated Their Satisfaction With The Following as Good to Excellent (>=3)
Ease of getting started
|
50 participants
|
|
Number of Participants Who Rated Their Satisfaction With The Following as Good to Excellent (>=3)
Readability of computer display
|
49 participants
|
|
Number of Participants Who Rated Their Satisfaction With The Following as Good to Excellent (>=3)
Usefulness of Log Book Report
|
50 participants
|
|
Number of Participants Who Rated Their Satisfaction With The Following as Good to Excellent (>=3)
Usefulness of Blood Sugar Trend Graph
|
50 participants
|
|
Number of Participants Who Rated Their Satisfaction With The Following as Good to Excellent (>=3)
Usefulness of Standard Day Graph
|
50 participants
|
|
Number of Participants Who Rated Their Satisfaction With The Following as Good to Excellent (>=3)
Usefulness of Standard Week Graph
|
50 participants
|
|
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
|
|
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
|
|
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
|
Adverse Events
Intended Users of the Software
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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
Phone: 574-257-3040
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60