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

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. 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