Effects of structured versus usual care on renal endpoint in type 2 diabetes: the SURE study: a randomized multicenter translational study

Abstract

Objective: Multifaceted care has been shown to reduce mortality and complications in type 2 diabetes. We hypothesized that structured care would reduce renal complications in type 2 diabetes.

Research design and methods: A total of 205 Chinese type 2 diabetic patients from nine public hospitals who had plasma creatinine levels of 150-350 micromol/l were randomly assigned to receive structured care (n = 104) or usual care (n = 101) for 2 years. The structured care group was managed according to a prespecified protocol with the following treatment goals: blood pressure <130/80 mmHg, A1C <7%, LDL cholesterol <2.6 mmol/l, triglyceride <2 mmol/l, and persistent treatment with renin-angiotensin blockers. The primary end point was death and/or renal end point (creatinine >500 micromol/l or dialysis).

Results: Of these 205 patients (mean +/- SD age 65 +/- 7.2 years; disease duration 14 +/- 7.9 years), the structured care group achieved better control than the usual care group (diastolic blood pressure 68 +/- 12 vs. 71 +/- 12 mmHg, respectively, P = 0.02; A1C 7.3 +/- 1.3 vs. 8.0 +/- 1.6%, P < 0.01). After adjustment for age, sex, and study sites, the structured care (23.1%, n = 24) and usual care (23.8%, n = 24; NS) groups had similar end points, but more patients in the structured care group attained >or=3 treatment goals (61%, n = 63, vs. 28%, n = 28; P < 0.001). Patients who attained >or=3 treatment targets (n = 91) had reduced risk of the primary end point (14 vs. 34; relative risk 0.43 [95% CI 0.21-0.86] compared with that of those who attained <or=2 targets (n = 114).

Conclusions: Attainment of multiple treatment targets reduced the renal end point and death in type 2 diabetes. In addition to protocol, audits and feedback are needed to improve outcomes.

Trial registration: ClinicalTrials.gov NCT00309127.

Figure 1

Overall study design and clinical outcomes of recruited patients.

Figure 2

Kaplan-Meier analysis showing the cumulative incidence of the primary composite end point of death or ESRD defined as dialysis or the need for dialysis or plasma creatinine level ≥500 μmol/l in type 2 diabetic patients with renal insufficiency stratified by attainment of ≥3 prespecified treatment targets. Treatment targets: 1) blood pressure <130/80 mmHg, 2) A1C <7%, 3) LDL cholesterol <2.6 mmol/l, 4) fasting plasma triglyceride <2 mmol/l, and 5) treatment with ACE inhibitors and/or ARBs.