N/A
N=51
Evaluation of DIDGET TM World Reports
Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT00923975 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Oct 2010
Primary outcome: Primary: Number of Participants Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks — 50; 50; 50; 50 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- DIDGET World Web Community Reports (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ascensia Diabetes Care
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks |
50; 50; 50; 50; 50; 49 | — |
| SECONDARY Number of Participants Who Rated Ease of Performing Specific Tasks as Very Simple to Neither Simple Nor Difficult (<=3 Rating) |
50; 50; 50; 50; 50; 40 | — |
| SECONDARY Number of Participants Who Rated Clarity and Usefulness of User Instructions as Good to Excellent (>=3) |
49; 47 | — |
| SECONDARY Number of Participants Who Rated Their Satisfaction With The Following as Good to Excellent (>=3) |
50; 49; 50; 50; 50; 50 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Lay users must be:
- Be at least 18 years of age
- Have diabetes or be the parent or legal guardian of a child with diabetes
- Be testing blood sugar at home at least twice daily for at least one month or be the parent or legal guardian of a child who has been testing blood sugar at home at least twice daily for at least one month
- Be able to speak, read, and understand English
- Have experience using a PC, navigating software programs, or browsing the internet
- Healthcare professionals must:
- Have experience using the internet
- Have experience using diabetes data management software in the medical office
Exclusion Criteria
- Person working for a competitive medical device company
- Person having a cognitive disorder or condition which, in the opinion of the investigator, would put the person at risk or compromise the integrity of the study.
Data sourced from ClinicalTrials.gov (NCT00923975). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.