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Clinical Trial
. 2001 Oct 27;323(7319):970-5.
doi: 10.1136/bmj.323.7319.970.

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

N F Olivarius  1 , H Beck-Nielsen, A H Andreasen, M Hørder, P A Pedersen
Affiliations
Clinical Trial

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

N F Olivarius et al. BMJ. .

Abstract

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.

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Flow of participants through trial
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Comment in

  • The management of diabetes.
    Griffin SJ. Griffin SJ. BMJ. 2001 Oct 27;323(7319):946-7. doi: 10.1136/bmj.323.7319.946. BMJ. 2001. PMID: 11679370 Free PMC article. No abstract available.

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