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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intended Users of the Software | Other | Young adults, parents/guardians of young people under age 18, and healthcare professionals who work with this population would be intended users of the data management program. The DIDGET World Reports software is used to upload blood glucose results from the DIDGET Blood Glucose Monitoring System so that intended users can identify patterns in their diabetes management. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DIDGET World Web Community Reports | Device | During the study subjects performed specific tasks, such as uploading meter results to a secure website and displaying reports. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 1-2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 1-2 hours |
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Inclusion Criteria:
Lay users must be:
Healthcare professionals must:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Bailey, MD | AMCR Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMCR Institute | Escondido | California | 92026 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline participants included young adults with diabetes (age 18 to 24)and parents/guardians (age 18 to 47) of children with diabetes; note healthcare professionals were not included in this measure. One young adult subject was withdrawn from the study (did not meet inclusion criteria) and the data was not used in the analysis. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:
| One subject was withdrawn from the study and the data was not used in the analysis. The subject did not meet inclusion criteria. | Posted | Number | participants | 1-2 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carmine Greene, Senior Clinical Research Scientist | Ascensia Diabetes Care | 574-257-3040 | carmine.greene@ascensia.com |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
| 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.
|
| 1-2 hours |
| 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:
| 1-2 hours |
| Median |
| Full Range |
| years |
|
| Sex: Female, Male | 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. | Count of Participants | Participants |
|
| Region of Enrollment | 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. | Number | participants |
|
| Units | Counts |
|---|---|
| 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.
| Posted | Number | participants | 1-2 hours |
|
|
|
| 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:
| One subject was withdrawn from the study and the data was not used in the analysis. The subject did not meet inclusion criteria. | Posted | Number | participants | 1-2 hours |
|
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| 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:
| One subject was withdrawn from the study and the data was not used in the analysis. The subject did not meet inclusion criteria. | Posted | Number | participants | 1-2 hours |
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| 0 |
| 50 |
| 0 |
| 50 |
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| Title | Measurements |
|---|---|
|
| Usefulness of Blood Sugar Trend Graph |
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| Usefulness of Standard Day Graph |
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| Usefulness of Standard Week Graph |
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| Usefulness of Summary Either Bar Or Pie Chart |
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| Overall, type of information software gives me is |
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| Overall, the ease of use of DIDGET World Reports |
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| Title | Measurements |
|---|---|
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| Display Blood Sugar Trend Report |
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| Display the Standard Day Report |
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| Change Daily Time Periods |
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| Display the Logbook |
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| Display the Standard Week Report |
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| Identify Out of Target Results |
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| Print the Standard Day and Standard Week Reports |
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| Display the Summary Report |
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| Save Summary Reports as a file on your computer |
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| Change Low and High Blood Sugar Ranges in Reports |
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| Log out of Web Reports |
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