ADDITION - 10 year follow up
Research type
Research Study
Full title
Anglo-Danish-Dutch study of Intensive Treatment of people with newly diagnosed diabetes in primary care (ADDITION) - ten year follow up
IRAS ID
160001
Contact name
Simon Griffin
Contact email
Sponsor organisation
University of Cambridge
ISRCTN Number
ISRCTN86769081
Clinicaltrials.gov Identifier
Research summary
People with diabetes have an increased risk of developing cardiovascular disease (heart attack or stroke). However, there can be a delay between the onset of diabetes and a person experiencing symptoms, making it difficult to detect early. It would be logical to suggest that if we found people earlier in the disease trajectory and treated them before symptoms developed, we could reduce the risk of them suffering from an early death or cardiovascular disease.
Until recently the effect of intensive treatment of multiple risk factors earlier in the course of diabetes was unknown. Results from the ADDITION trial, demonstrated that, compared to routine care, an intervention to promote intensive management of patients with diabetes detected by screening was associated with significant differences in prescribed treatment and levels of cardiovascular risk factors at five years. These differences were associated with a 17% reduction in risk of cardiovascular events that was not statistically significant, in other words it may have been due to chance.
The lower than expected event rate among screen-detected patients and the apparent divergence of event rates between groups suggests that further follow up of this cohort is justified to establish whether early treatment reduces long-term cardiovascular risk. Resolving this uncertainty is important in assessing the costs and benefits of screening for diabetes, and for informing early treatment decisions.
This study aims to collect information on cardiovascular events and risk factors, treatment and mortality for participants of the ADDITION study. This will allow us to assess the long-term effects of the differences in treatment during the first five years after diagnosis. We plan to contact all ADDITION participants in the UK with a self-report questionnaire to assess health behaviour and patient-reported outcomes. Each centre will also search medical records to collect data on intermediate biochemical and clinical measures, medication and health service use.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
14/EE/1129
Date of REC Opinion
25 Sep 2014
REC opinion
Favourable Opinion