• Aims of the study
• Design
• Steering Committee
• Status
• Unit role
• Sponsors
• Partners and stakeholders
• Funding
• Data sharing

Aims of the study

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. Half of the patients diagnosed with type 2 diabetes in the ADDITION study went on to receive standard care for type 2 diabetes from their general practice following national guidelines. The other half received an intensive treatment programme to reduce their risk of cardiovascular disease. This programme aimed to educate and support general practitioners and practice nurses in target-driven management of blood glucose, blood pressure and cholesterol.

Outcomes

The primary endpoint was a combination of first cardiovascular event, including cardiovascular mortality, cardiovascular morbidity (non-fatal myocardial infarction and non-fatal stroke), revascularisation, and non-traumatic amputation.

The secondary outcomes were the individual components of the primary endpoint and all-cause mortality:

Microvascular outcomes

• Retinopathy (ETDRS scale)
• Neuropathy (Michigan questionnaire)
• Nephropathy (ACR, eGFR)

Intermediate outcomes

• HbA_1c
• Total, HDL and LDL cholesterol and triglycerides
• Weight
• Height
• Blood pressure
• Smoking status
• Alcohol consumption
• Physical activity
• Diet
• Health utility
• Diabetes-dependent quality of life
• Diabetes treatment satisfaction
• Functional status
• Self-reported history of CVD events / procedures
• Health service use
• Current mediation use
• Sleep disorder
• Anxiety and depression

Steering Committee

Professor Annelli Sandbæk – Aarhus University

Professor Daniel Witte – Aarhus University

Professor Simon Griffin – University of Cambridge

Professor Nick Wareham – University of Cambridge

Professor Melanie J. Davies – University of Leicester

Professor Guy E.H.M. Rutten – University Medical Center Utrecht

Professor Kamlesh Khunti – University of Leicester

Status

Field work completed.

Unit role

Unit led study with responsibility for data.

Sponsors

The study is sponsored by the University of Cambridge.

Partners and Stakeholders

• MRC Epidemiology Unit at the University of Cambridge
• University Medical Center Utrecht
• University of Leicester
• Aarhus University

Funding

Unit involvement in ADDITION is funded by MRC core funding, plus grant support: Wellcome Trust (grant reference no: G061895), the Medical Research Council (grant reference no: G0001164), the NIHR Health Technology Assessment Programme (grant reference no: 08/116/300), National Institute for Health Research Programme Grants for Applied Research [RP-PG-0606-1259].National Health Service R&D support funding (including the Primary Care Research and Diabetes Research Networks) and the  The University of Cambridge has received salary support in respect of Simon Griffin from the NHS in the East of England through the Clinical Academic Reserve.

Data sharing

Please see our Data Sharing portal