Details of HTA project in progress
Last updated: 9 May 2012 - Next update due: 16 May 2012
Research type: |
Primary Research (e.g. trial) |
Project title: |
Anglo-Danish-Dutch study of Intensive Treatment of people with Newly diagnosed diabetes in primary care (ADDITION) - effects on cardiovascular events at five years |
Project ref: |
08/116/300 |
Cost: |
£496,830 |
Chief Investigator : |
Dr Simon Griffin, Assistant Director, MRC Epidemiology Unit, Medical Research Council |
Start Date: |
July 2010 |
Estimated date of publication in HTA journal series: |
Early 2015. This date takes account of time for report preparation and printing based on current average times for these activities. |
Plain English Summary |
Diabetes is a common chronic condition that is associated with an increased risk of heart disease, stroke, amputation, visual impairment and kidney damage. Currently most people become diagnosed with diabetes when they develop symptoms or a complication, but there is evidence to suggest that the true onset occurs several years earlier. Although it seems logical to propose that earlier detection of the disorder would result in health benefits, this has not been clearly established. Recent studies have suggested that careful attention needs to be given to raised blood glucose levels, elevated blood pressure and blood cholesterol levels. There is good evidence that treating all these risk factors simultaneously is beneficial for people who have had diabetes for many years, but it is not clear how effective such an approach will be in patients detected earlier by screening. This study aims to discover whether earlier detection and subsequent intensive treatment are worthwhile by quantifying the costs and benefits of such an approach. The study was set up in 2001. 55 GP practices in the Eastern region and 20 practices in the Leicestershire region agreed to participate. Following a step-wise screening procedure, 1,026 patients were diagnosed with diabetes. Surgeries were allocated by chance to either deliver intensive treatment (a combination of medication and advice on lifestyle changes, for example diet and physical activity) or standard care according to current national guidelines. Now that five years have passed, we have a unique opportunity to assess how effective this treatment has been and to see whether it has reduced the risk of developing diabetic complications such as heart attack, and premature death. As such, we are applying for funds to (i) assess the health status of all study participants up to the end of 2009; (ii) support the electronic management of data collected during this process; and, (iii) help us analyse the data including health economic analysis. We will also apply to the NHS for some support funding so that each participating GP practice can help by retrieving and reviewing participants’ medical records. Results from our study will help to improve care for patients with diabetes and provide information on whether people in middle-age should be offered screening for diabetes in the UK and worldwide. We plan to invite all study participants to attend a health assessment, which will involve a non-fasting blood sample, routine clinical measurements and self-report questionnaires (1.5hr visit). To assess whether patients have suffered a heart attack, stroke or amputation we will systematically search medical records. An independent reviewer will review these notes to assess whether an actual event has occurred. The number of events will be compared between each group to establish whether earlier detection and intensive treatment is worthwhile. We do not foresee any risk to participants taking part. The types of measures are very similar to those that would be experienced by participants in their own GP surgery. Ethical approval for the study has been granted. Our well-established teams have worked on several similar studies, achieving high levels of satisfaction among participants and excellent follow-up rates. |
Project Abstract: |
Diabetes is a common chronic condition that is associated with an increased risk of heart disease, stroke, amputation, visual impairment and kidney damage. Currently most people become diagnosed with diabetes when they develop symptoms or a complication, but there is evidence to suggest that the true onset occurs several years earlier. Although it seems logical to propose that earlier detection of the disorder would result in health benefits, this has not been clearly established. Recent studies have suggested that careful attention needs to be given to raised blood glucose levels, elevated blood pressure and blood cholesterol levels. There is good evidence that treating all these risk factors simultaneously is beneficial for people who have had diabetes for many years, but it is not clear how effective such an approach will be in patients detected earlier by screening. This study aims to discover whether earlier detection and subsequent intensive treatment are worthwhile by quantifying the costs and benefits of such an approach. The study was set up in 2001. 55 GP practices in the Eastern region and 20 practices in the Leicestershire region agreed to participate. Following a step-wise screening procedure, 1,026 patients were diagnosed with diabetes. Surgeries were allocated by chance to either deliver intensive treatment (a combination of medication and advice on lifestyle changes, for example diet and physical activity) or standard care according to current national guidelines. Now that five years have passed, we have a unique opportunity to assess how effective this treatment has been and to see whether it has reduced the risk of developing diabetic complications such as heart attack, and premature death. Results from our study will help to improve care for patients with diabetes and provide information on whether people in middle-age should be offered screening for diabetes in the UK and worldwide. |
ISRCTN* number: | ISRCTN 86769081 (*International Standard Randomised Controlled Trial Number) URL of this project on the Controlled Trials Website: http://www.controlled-trials.com/ISRCTN86769081 |
Project Protocol: |
Project protocol (pdf format, 164 kbytes) |
URL of this page: |
http://www.hta.ac.uk/2248 |
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