The ADDITION Study. Intensive Treatment in People With Screen Detected Diabetes in Primary Care.

NCT00237549 | Completed DMC

• 1 other identifier: The ADDITION-study
• Study Type: interventional
• Target: 3,057
• Locations: 3 countries
• Sites: 4

Brief Summary

The ADDITION study comprise 2 parts: screening for Type 2 diabetes and intensive treatment compared to standard treatment.

1. 1.In the screening study, the feasibility and results of country specific models to identify undiagnosed individuals with Type 2 diabetes will be evaluated.
2. 2.In the treatment study the effects of routine care in general practice according to local and national guidelines will be compared with an intensive ADDITION protocol, including structured lifestyle education (dietary modification, increased physical activity and smoking cessation) and intensive treatment of blood glucose, blood pressure and lipids, and prophylactic aspirin with or without motivational interviewing, on mortality, macrovascular and microvascular disease. Furthermore the impact of treatment on health status, treatment satisfaction and health service costs will also be assessed.

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes; Screening; Intensive treatment; Polypharmacy; Primary care

Outcome Measures

Primary Outcomes (5)

• Cardiovascular mortality

  Sept 2010

• MI (non fatal)

  Sept 2010

• Stroke (non fatal)

  Sept 2010

• Revascularisation (operating procedures)

  Sept 2010

• Amputations, non traumatic

  Sept 2010

Secondary Outcomes (6)

• All cause mortality

  2010

• Development of renal impairment

  2010

• Progression of retinopathy

  2010

• Health economy, patient and health service costs and gains

  2010

• Perceived health, SF36, AddQol

  2010

Study Arms (1)

Intervention

EXPERIMENTAL

The 334 general practices in Denmark, United Kingdom and the Netherlands have been randomised to screening for diabetes followed by routine care (RC group) according to national guidelines, or screening followed by multifactorial treatment (IT group).

Procedure: optimised treatment

Interventions

optimised treatment PROCEDURE

The intervention targeted individual patients and the Primary Care Team. Practitioners were trained in a target driven, intensive multifactorial approach including lifestyle advice (smoking cessation, physical activity 30 min./day and healthy diet) and pharmacological treatment with the aim of reducing the complications of diabetes as described in protocol. The training included meetings, practice visiting, written feed back reports and reminders on controls.

Intervention

Eligibility Criteria

• Age: 40 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Screening study: Every one aged 40-69 years (UK and DK) or 50-69 years(NL). Treatment study: All with screen detected type 2 diabetes.

You may not qualify if:

• Participants are excluded if they already have diabetes at time of screening, are pregnant or lactating or have a severe psychotic illness, are house bound or have an illness with a likely survival of less than one year.

Sponsors & Collaborators

• University of Aarhus: lead
• Steno Diabetes Centre, Gentofte, Denmark: collaborator
• University of Cambridge: collaborator
• University Hospitals, Leicester: collaborator
• Utrecht University: collaborator

Study Sites (4)

Institute of Public Health

Aarhus, Aarhus, 8000, Denmark

Location

Julius Centre for health Sciences and Primary Care, University of Utrecht

Utrecht, Netherlands

Location

Department of Public Health and general Practice

Cambridge, Cambridge, UK CB2 2SR, United Kingdom

Location

University Hospital and Department of Health Sciences, University of Leicster

Leicester, United Kingdom

Location

Related Publications (24)

• Lauritzen T, Griffin S, Borch-Johnsen K, Wareham NJ, Wolffenbuttel BH, Rutten G; Anglo-Danish-Dutch Study of Intensive Treatment in People with Screen Detected Diabetes in Primary Care. 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.

  PMID: 11063279 RESULT

• Sandbaek A, Griffin SJ, Rutten G, Davies M, Stolk R, Khunti K, Borch-Johnsen K, Wareham NJ, Lauritzen T. Stepwise screening for diabetes identifies people with high but modifiable coronary heart disease risk. The ADDITION study. Diabetologia. 2008 Jul;51(7):1127-34. doi: 10.1007/s00125-008-1013-0. Epub 2008 Apr 29.

  PMID: 18443762 RESULT

• Griffin SJ, Borch-Johnsen K, Davies MJ, Khunti K, Rutten GE, Sandbaek A, Sharp SJ, Simmons RK, van den Donk M, Wareham NJ, Lauritzen T. Effect of early intensive multifactorial therapy on 5-year cardiovascular outcomes in individuals with type 2 diabetes detected by screening (ADDITION-Europe): a cluster-randomised trial. Lancet. 2011 Jul 9;378(9786):156-67. doi: 10.1016/S0140-6736(11)60698-3. Epub 2011 Jun 24.

  PMID: 21705063 RESULT

• Do DV, Han G, Abariga SA, Sleilati G, Vedula SS, Hawkins BS. Blood pressure control for diabetic retinopathy. Cochrane Database Syst Rev. 2023 Mar 28;3(3):CD006127. doi: 10.1002/14651858.CD006127.pub3.

  PMID: 36975019 DERIVED

• Bjerg L, Laugesen E, Andersen ST, Rosborg JF, Charles M, Vistisen D, Witte DR. Long-term effects of intensive multifactorial treatment on aortic stiffness and central hemodynamics after 13 years with screen-detected type 2 diabetes: the ADDITION-Denmark trial. Diabetol Metab Syndr. 2022 Aug 17;14(1):116. doi: 10.1186/s13098-022-00890-1.

  PMID: 35978373 DERIVED

• Griffin SJ, Rutten GEHM, Khunti K, Witte DR, Lauritzen T, Sharp SJ, Dalsgaard EM, Davies MJ, Irving GJ, Vos RC, Webb DR, Wareham NJ, Sandbaek A. Long-term effects of intensive multifactorial therapy in individuals with screen-detected type 2 diabetes in primary care: 10-year follow-up of the ADDITION-Europe cluster-randomised trial. Lancet Diabetes Endocrinol. 2019 Dec;7(12):925-937. doi: 10.1016/S2213-8587(19)30349-3.

  PMID: 31748169 DERIVED

• Lundgren JR, Faerch K, Witte DR, Jonsson AE, Pedersen O, Hansen T, Lauritzen T, Holst JJ, Vistisen D, Jorgensen ME, Torekov SS, Johansen NB. Greater glucagon-like peptide-1 responses to oral glucose are associated with lower central and peripheral blood pressures. Cardiovasc Diabetol. 2019 Oct 5;18(1):130. doi: 10.1186/s12933-019-0937-7.

  PMID: 31586493 DERIVED

• Simmons RK, Bruun NH, Witte DR, Borch-Johnsen K, Jorgensen ME, Sandbaek A, Lauritzen T. Does training of general practitioners for intensive treatment of people with screen-detected diabetes have a spillover effect on mortality and cardiovascular morbidity in 'at risk' individuals with normoglycaemia? Results from the ADDITION-Denmark cluster-randomised controlled trial. Diabetologia. 2017 Jun;60(6):1016-1021. doi: 10.1007/s00125-017-4230-6. Epub 2017 Mar 9.

  PMID: 28280901 DERIVED

• Charles M, Skriver MV, Griffin SJ, Simmons RK, Witte DR, Dalsgaard EM, Lauritzen T, Sandbaek A. Does Training and Support of General Practitioners in Intensive Treatment of People with Screen-Detected Diabetes Improve Medication, Morbidity and Mortality in People with Clinically-Diagnosed Diabetes? Investigation of a Spill-Over Effect in a Cluster RCT. PLoS One. 2017 Feb 2;12(2):e0170697. doi: 10.1371/journal.pone.0170697. eCollection 2017.

  PMID: 28151941 DERIVED

• Simmons RK, Borch-Johnsen K, Lauritzen T, Rutten GE, Sandbaek A, van den Donk M, Black JA, Tao L, Wilson EC, Davies MJ, Khunti K, Sharp SJ, Wareham NJ, Griffin SJ. A randomised trial of the effect and cost-effectiveness of early intensive multifactorial therapy on 5-year cardiovascular outcomes in individuals with screen-detected type 2 diabetes: the Anglo-Danish-Dutch Study of Intensive Treatment in People with Screen-Detected Diabetes in Primary Care (ADDITION-Europe) study. Health Technol Assess. 2016 Aug;20(64):1-86. doi: 10.3310/hta20640.

  PMID: 27583404 DERIVED

• den Ouden H, Berends J, Stellato RK, Beulens JW, Rutten GE. Effect of six years intensified multifactorial treatment on levels of hs-CRP and adiponectin in patients with screen detected type 2 diabetes: the ADDITION-Netherlands randomized trial. Diabetes Metab Res Rev. 2015 Oct;31(7):758-66. doi: 10.1002/dmrr.2669. Epub 2015 Jul 30.

  PMID: 26109470 DERIVED

• Kuznetsov L, Simmons RK, Sandbaek A, Maindal HT. The impact of intensive multifactorial treatment on perceptions of chronic care among individuals with screen-detected diabetes: results from the ADDITION-Denmark trial. Int J Clin Pract. 2015 Apr;69(4):466-73. doi: 10.1111/ijcp.12570. Epub 2014 Nov 7.

  PMID: 25382351 DERIVED

• Simmons RK, Carlsen AH, Griffin SJ, Charles M, Christiansen JS, Borch-Johnsen K, Sandbaek A, Lauritzen T. Variation in prescribing of lipid-lowering medication in primary care is associated with incidence of cardiovascular disease and all-cause mortality in people with screen-detected diabetes: findings from the ADDITION-Denmark trial. Diabet Med. 2014 Dec;31(12):1577-85. doi: 10.1111/dme.12574. Epub 2014 Sep 29.

  PMID: 25185778 DERIVED

• Dalsgaard EM, Vestergaard M, Skriver MV, Borch-Johnsen K, Lauritzen T, Sandbaek A. Socioeconomic position and cardiovascular risk factors among people with screen-detected Type 2 DM: six-year follow-up of the ADDITION-Denmark trial. Prim Care Diabetes. 2014 Dec;8(4):322-9. doi: 10.1016/j.pcd.2014.01.006. Epub 2014 Mar 6.

  PMID: 24613817 DERIVED

• Van den Donk M, Griffin SJ, Stellato RK, Simmons RK, Sandbaek A, Lauritzen T, Khunti K, Davies MJ, Borch-Johnsen K, Wareham NJ, Rutten GE. Effect of early intensive multifactorial therapy compared with routine care on self-reported health status, general well-being, diabetes-specific quality of life and treatment satisfaction in screen-detected type 2 diabetes mellitus patients (ADDITION-Europe): a cluster-randomised trial. Diabetologia. 2013 Aug 20;56(11):2367-77. doi: 10.1007/s00125-013-3011-0. Online ahead of print.

  PMID: 23959571 DERIVED

• Maindal HT, Toft U, Lauritzen T, Sandbaek A. Three-year effects on dietary quality of health education: a randomized controlled trial of people with screen-detected dysglycaemia (The ADDITION study, Denmark). Eur J Public Health. 2013 Jun;23(3):393-8. doi: 10.1093/eurpub/cks076. Epub 2012 Jun 13.

  PMID: 23132875 DERIVED

• Charles M, Fleischer J, Witte DR, Ejskjaer N, Borch-Johnsen K, Lauritzen T, Sandbaek A. Impact of early detection and treatment of diabetes on the 6-year prevalence of cardiac autonomic neuropathy in people with screen-detected diabetes: ADDITION-Denmark, a cluster-randomised study. Diabetologia. 2013 Jan;56(1):101-8. doi: 10.1007/s00125-012-2744-5. Epub 2012 Oct 12.

  PMID: 23064291 DERIVED

• Simmons RK, Sharp SJ, Sandbaek A, Borch-Johnsen K, Davies MJ, Khunti K, Lauritzen T, Rutten GE, van den Donk M, Wareham NJ, Griffin SJ. Does early intensive multifactorial treatment reduce total cardiovascular burden in individuals with screen-detected diabetes? Findings from the ADDITION-Europe cluster-randomized trial. Diabet Med. 2012 Nov;29(11):e409-16. doi: 10.1111/j.1464-5491.2012.03759.x.

  PMID: 22823477 DERIVED

• Johansen NB, Charles M, Vistisen D, Rasmussen SS, Wiinberg N, Borch-Johnsen K, Lauritzen T, Sandbaek A, Witte DR. Effect of intensive multifactorial treatment compared with routine care on aortic stiffness and central blood pressure among individuals with screen-detected type 2 diabetes: the ADDITION-Denmark study. Diabetes Care. 2012 Nov;35(11):2207-14. doi: 10.2337/dc12-0176. Epub 2012 Jul 11.

  PMID: 22787176 DERIVED

• Charles M, Ejskjaer N, Witte DR, Borch-Johnsen K, Lauritzen T, Sandbaek A. Prevalence of neuropathy and peripheral arterial disease and the impact of treatment in people with screen-detected type 2 diabetes: the ADDITION-Denmark study. Diabetes Care. 2011 Oct;34(10):2244-9. doi: 10.2337/dc11-0903. Epub 2011 Aug 4.

  PMID: 21816977 DERIVED

• Lauritzen T, Sandbaek A, Skriver MV, Borch-Johnsen K. HbA1c and cardiovascular risk score identify people who may benefit from preventive interventions: a 7 year follow-up of a high-risk screening programme for diabetes in primary care (ADDITION), Denmark. Diabetologia. 2011 Jun;54(6):1318-26. doi: 10.1007/s00125-011-2077-9. Epub 2011 Feb 22.

  PMID: 21340624 DERIVED

• Dalsgaard EM, Christensen JO, Skriver MV, Borch-Johnsen K, Lauritzen T, Sandbaek A. Comparison of different stepwise screening strategies for type 2 diabetes: Finding from Danish general practice, Addition-DK. Prim Care Diabetes. 2010 Dec;4(4):223-9. doi: 10.1016/j.pcd.2010.06.003. Epub 2010 Aug 1.

  PMID: 20675208 DERIVED

• Juul L, Sandbaek A, Foldspang A, Frydenberg M, Borch-Johnsen K, Lauritzen T. Adherence to guidelines in people with screen-detected type 2 diabetes, ADDITION, Denmark. Scand J Prim Health Care. 2009;27(4):223-31. doi: 10.3109/02813430903279117.

  PMID: 19929182 DERIVED

• Rubak S, Sandbaek A, Lauritzen T, Borch-Johnsen K, Christensen B. General practitioners trained in motivational interviewing can positively affect the attitude to behaviour change in people with type 2 diabetes. One year follow-up of an RCT, ADDITION Denmark. Scand J Prim Health Care. 2009;27(3):172-9. doi: 10.1080/02813430903072876.

  PMID: 19565411 DERIVED

Related Links

• Study Website

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Torsten Lauritzen, Professor

  Institutute of Public Health, Dep. of General practice, Aarhus University, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2005
• First Posted: October 12, 2005
• Study Start: January 1, 2001
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 20, 2013

Record last verified: 2012-08

Locations

GB (2); NL (1); DK (1)