The 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.


METHODS
Population-based screening in three European countries followed by an open, randomised controlled trial.


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.
Lauritzen
T
T
Department of General Practice, University of Aarhus, Denmark.
Griffin
S
S
Borch-Johnsen
K
K
Wareham
N J
NJ
Wolffenbuttel
B H
BH
Rutten
G
G
D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000032:analysis; D003362:Cost-Benefit Analysis; D003718:Denmark / Q000453:epidemiology; D003924:Diabetes Mellitus, Type 2 / Q000175:diagnosis / Q000191:economics / Q000453:epidemiology / Q000628:therapy*; D004739:England / Q000453:epidemiology; D005260:Female; D006801:Humans; D006943:Hyperglycemia / Q000150:complications / Q000191:economics / Q000628:therapy; D008297:Male; D008403:Mass Screening / Q000191:economics*; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009426:Netherlands / Q000453:epidemiology; D017410:Practice Guidelines as Topic; D015995:Prevalence; D011320:Primary Health Care / Q000191:economics*; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D012307:Risk Factors; D014652:Vascular Diseases / Q000209:etiology / Q000401:mortality / Q000628:therapy
D001786:Blood Glucose