Evaluation of a Diabetes Data Management System
This study has been completed.
Sponsor:
Bayer HealthCare, Diabetes Care
Information provided by (Responsible Party):
Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier:
NCT00694070
First received: June 6, 2008
Last updated: January 26, 2012
Last verified: January 2012
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Results First Received: July 1, 2009
| Study Type: | Observational |
|---|---|
| Study Design: | Observational Model: Case-Only; Time Perspective: Cross-Sectional |
| Condition: |
Diabetes |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Health Care Professionals and Lay Users | h= 8 health care professionals p= 43 lay users |
Participant Flow: Overall Study
| Health Care Professionals and Lay Users | |
|---|---|
| STARTED | 51 |
| COMPLETED | 51 |
| NOT COMPLETED | 0 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Health Care Professionals and Lay Users | h= 8 health care professionals p= 43 lay users |
Baseline Measures
| Health Care Professionals and Lay Users | |
|---|---|
|
Number of Participants
[units: participants] |
51 |
|
Age
[units: years] Median ( Full Range ) |
53
( 18 to 82 ) |
|
Gender
[units: participants] |
|
| Female | 29 |
| Male | 22 |
Outcome Measures
| 1. 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) [ Time Frame: 1-2 hours ] |
| 2. Primary: | Number of Participants Rated as <= 3 (Success in Using the Program) [ Time Frame: 1-2 hours ] |
| 3. Primary: | Number of Participants That Could Answer at Least 85% of the Comprehension Questions Correctly (Comprehension of the Program Reports) [ Time Frame: 1-2 hours ] |
Serious Adverse Events| Time Frame | No text entered. |
|---|---|
| Additional Description | No text entered. |
Reporting Groups
| Description | |
|---|---|
| Health Care Professionals and Lay Users | h= 8 health care professionals p= 43 lay users |
Serious Adverse Events
| Health Care Professionals and Lay Users | |
|---|---|
| Total, serious adverse events | |
| # participants affected / at risk | 0/51 (0.00%) |
Other Adverse Events
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| Principal Investigators are NOT employed by the organization sponsoring the study. |
| There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
Results Point of Contact:
Name/Title: Clinical Research Scientist
Organization: Bayer Healthcare, Diabetes Care
phone: 574-257-3063
Organization: Bayer Healthcare, Diabetes Care
phone: 574-257-3063
No publications provided
| Responsible Party: | Bayer HealthCare, Diabetes Care |
| ClinicalTrials.gov Identifier: | NCT00694070 History of Changes |
| Other Study ID Numbers: | CTD-2008-11 |
| Study First Received: | June 6, 2008 |
| Results First Received: | July 1, 2009 |
| Last Updated: | January 26, 2012 |
| Health Authority: | United States: Institutional Review Board |