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The purpose of this study is to evaluate a Diabetes management program in the hands of potential users, both health care professionals and lay persons.
Diabetes data management programs upload glucose meter results to computers to provide information at home to lay people with diabetes and their healthcare professionals to manage their diabetes. The study evaluated the subjects' success using the software program with a blood glucose meter to perform specific tasks, such as uploading the meter results, changing program and meter settings, and displaying reports. The study also evaluated the system's ease of use and the acceptability of product labeling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intended Users of the Software | Experimental | 10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) using a diabetes data management program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLUCOFACTS® Deluxe | Device | Diabetes Data Management Software |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Rated Successful (<=3) at Performing Specific Tasks | Study staff rated participants on their success at perfoming specific tasks. The rating scale was:
| 1-2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3 | Subjects rated ease of using the software with respect to specific tasks. The rating scale was:
| 1-2 hours |
| Number of Participants Who Rated Clarity and Usefulness of User Instructions as >=3 |
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Inclusion Criteria:
Lay users must:
HCPs 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 |
One subject was withdrawn for non-compliance. The subject was a parent of a child with diabetes and the 17 year old child was performing the software evaluation instead of the parent. The protocol states that the subjects were to be 18 years and older. The subject was withdrawn from the study and the data was not used in the analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intended Users of the Software | 10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) 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 apply to lay persons (n=40) not healthcare professionals in the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Baseline measures apply to lay persons (n=40) not healthcare professionals in the study. Ages ranged from 18 to 67 years. |
| 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 | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Rated Successful (<=3) at Performing Specific Tasks | Study staff rated participants on their success at perfoming specific tasks. The rating scale was:
| Note: 2 tasks were performed only by the 10 healthcare professionals. Also, one lay person was withdrawn (leaving 50 participants). The subject was a parent of a child with diabetes;the 17 year old child performed the software evaluation instead of the parent. Data for the subject withdrawn from the study was not used in the analysis. | Posted | Apr 2010 | 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 | 10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) 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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User instructions included online help, User Guide, and a Quick Reference Guide. Subjects rated their clarity and usefulness and the rating scale was:
|
| 1-2 hours |
| Median |
| Full Range |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) used a diabetes data management program. |
|
|
| Secondary | Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3 | Subjects rated ease of using the software with respect to specific tasks. The rating scale was:
| Note: 2 tasks were performed only by the 10 healthcare professionals. Also, one lay person was withdrawn (leaving 50 participants). The subject was a parent of a child with diabetes; the 17 year old child performed the software evaluation instead of the parent. Data for the subject withdrawn from the study was not used in the analysis. | Posted | Apr 2010 | Number | percentage of participants | 1-2 hours |
|
|
|
| Secondary | Number of Participants Who Rated Clarity and Usefulness of User Instructions as >=3 | User instructions included online help, User Guide, and a Quick Reference Guide. Subjects rated their clarity and usefulness and the rating scale was:
| Some subjects had no opinion; the number of subjects that did respond with ratings are identified in parentheses. | Posted | Apr 2010 | Number | participants | 1-2 hours |
|
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| 0 |
| 51 |
| 0 |
| 51 |
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| Title | Measurements |
|---|---|
|
| Display the 'standard day' report |
|
| Display the logbook |
|
| Enter a Hemoglobin A1c result to the logbook |
|
| Find A1c result in logbook |
|
| Change Blood sugar (BS) ranges in the software |
|
| Change personal BS ranges in the CONTOUR meter |
|
| Change CONTOUR meter settings |
|
| Download CONTOUR USB meter |
|
| Display the 'Summary' report |
|
| Change CONTOUR USB meter HI and LO settings |
|
| Change CONTOUR USB meter trends length |
|
| Change default BS ranges for patients (HCPs only) |
|
| Find patient in database / view data (HCPs only) |
|
| Title | Measurements |
|---|---|
|
| Usefulness of instructions in User Guide (n=30) |
|
| Usefulness-instructions Quick Reference Guide(33) |
|
| Usefulness of the online help (n=31) |
|