Evaluation of DIDGET TM World Reports

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier:
NCT00923975
First received: June 17, 2009
Last updated: January 26, 2012
Last verified: January 2012
Results First Received: June 10, 2010  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Diabetes
Intervention: Device: DIDGET World Web Community Reports

  Participant Flow
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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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Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Intended Users of the Software  
STARTED     51  
COMPLETED     50 [1]
NOT COMPLETED     1  
Did not meet inclusion criteria                 1  
[1] One subject did not meet inclusion criteria; the data was not used in analysis.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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 Data was not used from one subject withdrawn from the study because the subject did not meet inclusion criteria.

Baseline Measures
    Intended Users of the Software  
Number of Participants  
[units: participants]
  47  
Age [1]
[units: years]
Median ( Full Range )
  26.9  
  ( 18 to 47 )  
Gender [2]
[units: participants]
 
Female     29  
Male     18  
Region of Enrollment [2]
[units: participants]
 
United States     47  
[1] 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.
[2] 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.



  Outcome Measures
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1.  Primary:   Number of Participants Out of 50 Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks   [ Time Frame: 1-2 hours ]

2.  Secondary:   Number of Participants Out of 50 Who Rated Ease of Performing Specific Tasks as Very Simple to Neither Simple Nor Difficult (<=3 Rating)   [ Time Frame: 1-2 hours ]

3.  Secondary:   Number of Participants Who Rated Clarity and Usefulness of User Instructions as Good to Excellent (>=3)   [ Time Frame: 1-2 hours ]

4.  Secondary:   Number of Participants Out of 50 Who Rated Their Satisfaction With The Following as Good to Excellent (>=3)   [ Time Frame: 1-2 hours ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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: Carmine Greene, Clinical Research Scientist
Organization: Bayer Healthcare, Diabetes Care
phone: 574-257-3040
e-mail: carmine.greene.b@bayer.com


No publications provided


Responsible Party: Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier: NCT00923975     History of Changes
Other Study ID Numbers: CTD-2009-08
Study First Received: June 17, 2009
Results First Received: June 10, 2010
Last Updated: January 26, 2012
Health Authority: United States: Institutional Review Board