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PreprintCC BY-NC-NDmedRxiv

Proof-of-implementation of the SMART2D intervention: findings from a cluster randomised feasibility trial for prevention and control of type 2 diabetes in socio-economically disadvantaged neighbourhoods in Stockholm, Sweden

  1. 1Uppsala University

Abstract

BackgroundType 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.

ObjectiveTo 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.

MethodsA 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.

ResultsAmong 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).

ConclusionsIntegrated 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.

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BibTeX
@misc{daivadanam2026proofofimplementation,
  title = {{Proof-of-implementation of the SMART2D intervention: findings from a cluster randomised feasibility trial for prevention and control of type 2 diabetes in socio-economically disadvantaged neighbourhoods in Stockholm, Sweden}},
  author = {M. Daivadanam and K. Sidney Annerstedt and H. Alveson and L. Timm and C. Johan Sundberg and P. Delobelle and J. V. Olmen and P. Absetz and D. Guwatudde},
  howpublished = {medRxiv},
  year = {2026},
  month = sep,
  doi = {10.64898/2026.09.30.26364359},
  url = {https://www.medrxiv.org/content/10.64898/2026.09.30.26364359v1},
  note = {CC BY-NC-ND},
}
RIS
TY  - UNPB
TI  - Proof-of-implementation of the SMART2D intervention: findings from a cluster randomised feasibility trial for prevention and control of type 2 diabetes in socio-economically disadvantaged neighbourhoods in Stockholm, Sweden
AU  - M. Daivadanam
AU  - K. Sidney Annerstedt
AU  - H. Alveson
AU  - L. Timm
AU  - C. Johan Sundberg
AU  - P. Delobelle
AU  - J. V. Olmen
AU  - P. Absetz
AU  - D. Guwatudde
PY  - 2026
DA  - 2026/09/30
PB  - medRxiv
DO  - 10.64898/2026.09.30.26364359
UR  - https://www.medrxiv.org/content/10.64898/2026.09.30.26364359v1
AB  - BackgroundType 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.  ObjectiveTo 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.  MethodsA 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.  ResultsAmong 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).  ConclusionsIntegrated 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.
ER  -