An interventional study of Computer-based Program in Diabetes Mellitus, Type 2, sponsored by Queen's University, Belfast. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-16.
Sponsored by Queen's University, Belfast · Not applicable, Interventional, and Supportive care
NEW Brief Summary: Managing diet and physical activity are vital aspects of diabetes self-care; however, people with diabetes often find it difficult to make changes to their usual diet and physical activity patterns. There is some evidence that computer based education may help some people develop the skills they need to better manage their diabetes. The investigators have developed an external hard drive (a USB stick), focusing on knowledge, self-monitoring, goal setting and skill-development in relation to diet and physical activity for people with Type 2 diabetes. A major emphasis was placed on eliciting the views of people with Type 2 diabetes throughout the development of the computer based program. This study will examine whether this computer based program can improve knowledge, skills and self-care behaviour in people with diabetes. One hundred participants who have been diagnosed with Type 2 diabetes in the past 2 years will be assigned by chance to one of two groups: they will either be assigned to continue with their normal care routine consulting with their doctor as normal, or they will be assigned to use the USB stick at least once a week for 12 weeks.
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 84 is close to the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Queen's University, Belfast is the lead sponsor of 116 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Use of Computer-based Program for 12 weeks
Behavioral: Computer-based Program
Usual care and list of useful websites
The intervention group will receive an initial training session which will include a demonstration of the layout and main features of the computer-based program and some instructions on how to navigate around the different sections of the program. As a minimum level of use, participants will be asked to use the self-monitoring and goal setting aspects of the computer-based program on at least a weekly basis.
Between Group Differences in Diabetes Knowledge
ADKnowl questionnaire
Time frame: 12 weeks
Between Group Differences in Goal Setting
Time frame: 12 weeks
Between Group Differences in Dietary Intake
Time frame: 12 weeks
Between Group Differences in Physical Activity Levels
Time frame: 12 weeks
Between Group Difference in Anthropometry
Time frame: 12 weeks
Between Group Differences in Markers of Cardiovascular Risk
Time frame: 12 weeks
Between Group Differences in Markers of Blood Glucose Control
Time frame: 12 weeks
Between Group Differences in Self-Efficacy and Barriers to Management of Diabetes
Time frame: 12 weeks
| Milestone | 1 Computer-based Program | 2 Control |
|---|---|---|
| Started | 41 | 43 |
| Completed | 32 | 38 |
| Not completed | 9 | 5 |
| Withdrew: Lost to follow-up | 5 | 5 |
| Withdrew: Computer problem | 3 | 0 |
| Withdrew: No longer interested in participating | 1 | 0 |
ADKnowl questionnaire
| Percent of items correct | 1 Computer-based Program | 2 Control |
|---|---|---|
| Between Group Differences in Diabetes Knowledge | 67 ± 10.4 | 64 ± 14.2 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 1 Computer-based Program | — | 0/41 (0%) | 0/41 (0%) |
| 2 Control | — | 0/43 (0%) | 0/43 (0%) |
| Age, Continuous(years) | 1 Computer-based Program | 2 Control | Total |
|---|---|---|---|
| Mean | 58 ± 9.1 | 60 ± 10.7 | 59 ± 9.9 |
| Sex: Female, Male(Participants) | 1 Computer-based Program | 2 Control | Total |
|---|---|---|---|
| Female | 19 | 16 | 35 |
| Male | 22 | 27 | 49 |
| Race and Ethnicity Not Collected(Participants) | 1 Computer-based Program | 2 Control | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
The record gives a start of Apr 2009, a primary completion of Dec 2010 and a completion of Dec 2010. It does not say whether these dates are actual or estimated.
Results were first posted in May 2023, 12 years 5 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.