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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| health care professionals and lay users | h= 8 health care professionals p= 43 lay users |
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| Measure | Description | Time Frame |
|---|---|---|
| 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.
| 1-2 hours |
| 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:
| 1-2 hours |
| 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. | 1-2 hours |
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Inclusion Criteria:
Health Care Professionals:
Lay users must:
Exclusion Criteria:
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Lay users males or females and health care professionals.
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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 | Health Care Professionals and Lay Users | h= 8 health care professionals p= 43 lay users |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Health Care Professionals and Lay Users | h= 8 health care professionals p= 43 lay users |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 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.
| per protocol | Posted | Jun 2009 | 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 | Health Care Professionals and Lay Users | h= 8 health care professionals p= 43 lay users |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Scientist | Ascensia Diabetes Care | 574-257-3063 |
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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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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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:
| Posted | Jun 2009 | Number | Participants | 1-2 hours |
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| 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. | Posted | Jun 2009 | Number | participants | 1-2 hours |
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