Abstract / Summary
Background Type 2 diabetes (T2D) disproportionately affects socioeconomically disadvantaged communities. Evidence on the feasibility and effectiveness of prevention and self-management strategies in complex contexts remains limited. Objective To report effectiveness outcomes from a feasibility trial comparing the SMART2D intervention with routine primary care for T2D prevention and control in two neighbourhoods in Stockholm. Methods A cluster-randomized feasibility trial with hybrid type 1 design was conducted in two neighbourhoods among individuals at high risk of T2D (n=84) or with diagnosed T2D (n=58), allocated to an integrated care arm (n=70; personal coaching and community outreach) or facility-only arm (n=72; routine care). Primary outcomes were glycaemic control (participants with T2D) and HbA1c reduction (participants at high risk of T2D); secondary outcomes were retention to care and diabetes incidence (participants at high risk of T2D). Analysis used intention-to-treat principles: difference-in-differences with mixed-effects models for HbA1c reduction, and modified Poisson regression (IRR, 95% CI) for other outcomes. Results Among participants with T2D, glycaemic control (adjusted IRR=0.92, 95% CI=0.89-0.95) and retention to care (adjusted IRR=0.91, 95% CI=0.91-0.92) were significantly lower in the integrated care arm. Among participants at high risk of T2D, integrated care showed a marginally significant, greater HbA1c reduction (adjusted 2.02, 0.20-3.84) and significantly higher retention to care (adjusted IRR=1.22, 1.15-1.29), plus fewer incident diabetes cases (0 vs. 2 in facility-only). Conclusions Integrated care (personal coaching, community outreach) benefited HbA1c reduction and retention among participants at high risk of T2D, whereas facility-only care improved glycaemic control and retention among participants with T2D.