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

Int J Obes Relat Metab Disord. 2000 Sep;24 Suppl 3:S6-11. doi: 10.1038/sj.ijo.0801420.

Abstract

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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Blood Glucose / analysis
  • Cost-Benefit Analysis
  • Denmark / epidemiology
  • Diabetes Mellitus, Type 2 / diagnosis
  • Diabetes Mellitus, Type 2 / economics
  • Diabetes Mellitus, Type 2 / epidemiology
  • Diabetes Mellitus, Type 2 / therapy*
  • England / epidemiology
  • Female
  • Humans
  • Hyperglycemia / complications
  • Hyperglycemia / economics
  • Hyperglycemia / therapy
  • Male
  • Mass Screening / economics*
  • Middle Aged
  • Multicenter Studies as Topic
  • Netherlands / epidemiology
  • Practice Guidelines as Topic
  • Prevalence
  • Primary Health Care / economics*
  • Randomized Controlled Trials as Topic / methods
  • Risk Factors
  • Vascular Diseases / etiology
  • Vascular Diseases / mortality
  • Vascular Diseases / therapy

Substances

  • Blood Glucose