ADDITION study: proposed trial of the cost-effectiveness of an intensive multifactorial intervention on morbidity and mortality among people with Type 2 diabetes detected by screening

OBJECTIVE: The overall aims of the ADDITION study are to evaluate whether screening for prevalent undiagnosed Type 2 diabetes is feasible, and whether subsequent optimised intensive treatment of diabetes, and associated risk factors, is feasible and beneficial. DESIGN: Population-based screening in...

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Bibliographic Details
Published in:International Journal of Obesity 2000-09, Vol.24 (S3), p.S6-S11
Main Authors: Lauritzen, T, Griffin, S, Borch-Johnsen, K, Wareham, N.J, Wolffenbuttel, B.H.R, Rutten, G
Format: Article
Language:English
Subjects:
angiotensin-converting enzyme inhibitors
aspirin
blood glucose
Blood pressure
cholesterol
Cost analysis
cost effectiveness
Diabetes
drug therapy
elderly
fasting
Glucose
guidelines
health status
Hyperglycemia
Intervention
lifestyle
Morbidity
Mortality
noninsulin-dependent diabetes mellitus
Obesity
patients
physicians
Primary care
randomized clinical trials
Risk factors
screening
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Summary:OBJECTIVE: The overall aims of the ADDITION study are to evaluate whether screening for prevalent undiagnosed Type 2 diabetes is feasible, and whether subsequent optimised intensive treatment of diabetes, and associated risk factors, is feasible and beneficial. DESIGN: Population-based screening in three European countries followed by an open, randomised controlled trial. SUBJECTS AND METHODS: People aged 40-69 y in the community, without known diabetes, will be offered a random capillary blood glucose screening test by their primary care physicians, followed, if equal to or greater than 5.5 mmol/l, by fasting and 2-h post-glucose-challenge blood glucose measurements. Three thousand newly diagnosed patients will subsequently receive conventional treatment (according to current national guidelines) or intensive multifactorial treatment (lifestyle advice, prescription of aspirin and ACE-inhibitors, in addition to protocol-driven tight control of blood glucose, blood pressure and cholesterol). Patients allocated to intensive treatment will be further randomised to centre-specific interventions to motivate adherence to lifestyle changes and medication. Duration of follow-up is planned for 5 y. Endpoints will include mortality, macrovascular and microvascular complications, patient health status and satisfaction, process-of-care indicators and costs.
ISSN:0307-0565
1476-5497
DOI:10.1038/sj.ijo.0801420