Background: The objective of this study was to determine whether the management of type 2 diabetes (DM2) can be transferred from an internist to a nurse specialised in diabetes (NSD). Methods: Ninety-three patients with DM2 referred by their general practitioner were randomised; 84 patients completed the study. The intervention group received care from an NSD who treated glycaemia, blood pressure and lipid profile by
protocol. The control group received care from an internist. The primary endpoint was the main decrease in HbA1c. Secondary endpoints included blood pressure, lipid profile, healthcare costs, QOL , and patient satisfaction. Results: HbA1c, total cholesterol, LDL cholesterol and cholesterol/HDL ratio decreased significantly in both study populations after a follow-up time of 12 months. Cholesterol/HDL ratio decreased by 0.4 and 0.9 in the NSD and control group respectively (p=0.034 for the difference between groups). The decreases (95% confidence interval) in systolic blood pressure were 8.6 mmHg (2.6, 14.7) in the NSD group and 4.0 mmHg (-0.9, 8.9) in the control group, without a significant difference between groups. After one year, 33.3% of the patients in the NSD group achieved an HbA1c level <7% compared with 2.2% at baseline (p=0.002). Healthcare costs were less and patient satisfaction with the NSD s was significantly better
(p<0.001), while maintaining the same QOL . Conclusion: NSD s using treatment protocols are able to
provide effective care for patients with DM 2, comparable
with the care provided by an internist, with respect to
clinical parameters, and superior with respect to healthcare costs and patient satisfaction.