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

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 greater than or equal to 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.