Effective translation of a type-2 diabetes primary prevention programme into routine primary care: The PreDE cluster randomised clinical trial

Abstract

AimsWe assessed the effectiveness of a Type 2 diabetes mellitus (T2D) prevention programme in routine primary health care (PHC) in high-risk patients. MethodsPhase IV cluster clinical trial involving 14 PHC centres in the Basque Health Service were randomised to the DE-PLAN educational healthy lifestyle promotion programme or standard care. All non-diabetic 45- to 70-year-old PHC attendees considered at high risk of T2D (FINDRISC ≥ 14 points) were eligible. The primary outcome was the 24-month cumulative incidence of T2D confirmed by oral glucose tolerance testing. Secondary outcomes were self-reported physical activity and dietary changes at 12 months in a subsample. ResultsOf the 4170 patients screened, 2128 (51%) were considered high risk, but 355 (33%) and 459 (43.6%) refused to participate in the control and intervention groups, respectively. Of all eligible non-diabetic patients, 634 and 454 were included in the control and intervention arms, 545 (85.9%) and 411 (90.5%) completed the follow-up. Intention-to-treat cumulative incidences of T2D were 12.1% (77/634) in the control group and 8.4% (38/454) in intervention group, with an absolute difference of 3.8% (95% CI: 0.18%–7.4%, p = 0.045) and a relative risk reduction of 32% (0.68; 95% CI: 0.47–0.99, p = 0.048) in favour of the intervention. Intervention patients were 1.83-fold more likely to meet recommended physical activity levels at 12 months (95% CI: 1.06–3.17, p = 0.03). ConclusionsThe DE-PLAN programme was effective in reducing T2D incidence in PHC high-risk patients. Research on implementation strategies to improve its feasible and sustainable adoption, reach and public health impact is warranted.