BMJ 2001;323:970 ( 27 October )

Primary care

Randomised controlled trial of structured personal care of type 2 diabetes mellitus

Niels de Fine Olivarius, associate professor, a Henning Beck-Nielsen, professor of endocrinology, b Anne Helms Andreasen, statistician, c Mogens Hørder, professor of clinical biochemistry, d Poul A Pedersen, research director. a

a Central Research Unit and Department of General Practice, University of Copenhagen, Panum Institute, DK-2200, Copenhagen, Denmark, b Medical Department M, Odense University Hospital, University of Southern Denmark, DK-5000 Odense, Denmark, c Department of Biostatistics, Institute of Public Health, University of Copenhagen, Panum Institute, d Department of Clinical Biochemistry, Odense University Hospital, University of Southern Denmark

Correspondence to: N deF Olivarius no{at}gpract.ku.dk

Objective: To assess the effect of a multifaceted intervention directed at general practitioners on six year mortality, morbidity, and risk factors of patients with newly diagnosed type 2 diabetes.
Design: Pragmatic, open, controlled trial with randomisation of practices to structured personal care or routine care; analysis after 6 years.
Setting: 311 Danish practices with 474 general practitioners (243 in intervention group and 231 in comparison group).
Participants: 874 (90.1%) of 970 patients aged >= 40 years who had diabetes diagnosed in 1989-91 and survived until six year follow up.
Intervention: Regular follow up and individualised goal setting supported by prompting of doctors, clinical guidelines, feedback, and continuing medical education.
Main outcome measures: Predefined clinical non-fatal outcomes, overall mortality, risk factors, and weight.
Results: Predefined non-fatal outcomes and mortality were the same in both groups. The following risk factor levels were lower for intervention patients than for comparison patients (median values): fasting plasma glucose concentration (7.9 v 8.7 mmol/l, P=0.0007), glycated haemoglobin (8.5% v 9.0%, P<0.0001; reference range 5.4-7.4%), systolic blood pressure (145 v 150 mm Hg, P=0.0004), and cholesterol concentration (6.0 v 6.1 mmol/l, P=0.029, adjusted for baseline concentration). Both groups had lost weight since diagnosis (2.6 v 2.0 kg). Metformin was the only drug used more frequently in the intervention group (24% (110/459) v 15% (61/415)).Intervention doctors arranged more follow up consultations, referred fewer patients to diabetes clinics, and set more optimistic goals.
Conclusions: In primary care, individualised goals with educational and surveillance support may for at least six years bring risk factors of patients with type 2 diabetes to a level that has been shown to reduce diabetic complications but without weight gain.


What is already known on this topic
Evidence is increasing that control of hyperglycaemia, hypertension, and dyslipidaemia may postpone the development of diabetic complications in patients with type 2 diabetes

Maintaining good control over a long period can be difficult

What this study adds
Structured individualised personal care with educational and surveillance support for general practitioners reduced levels of risk factors in type 2 diabetic patients after six years

Risk factors were reduced to a level that has been shown to have a beneficial effect on diabetic complications

Participants also showed modest weight loss



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Rapid Responses:

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The best therapy of diabetes mellitus type 2 and its complications is its primary prevention.
Sergio Stagnaro
bmj.com, 26 Oct 2001 [Full text]
More analyses
Belinda Ireland
bmj.com, 3 Nov 2001 [Full text]
Re: The best therapy of diabetes mellitus type 2 and its complications is its primary prevention.
Niels de Fine Olivarius
bmj.com, 22 Nov 2001 [Full text]
Re: More analyses
Niels de Fine Olivarius
bmj.com, 22 Nov 2001 [Full text]
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