Summary: In 58 uninsured Hispanic adults with type 2 diabetes treated at a single nonprofit community clinic, the community-health-worker-led TIME programme (telehealth, integrated CHWs, medication access, and group-visit education) was compared with usual care over 12 months. A larger HbA1c reduction was seen at 6 months (-0.85% vs +0.35%; p=.004), but the 12-month between-group difference was not statistically significant (-0.52% vs +0.25%; p=.062). The study was designed to assess implementation feasibility, and net cost savings of $16,435 ($566/participant) were reported.
PICO Summary
| Element | Detail |
|---|---|
| Population | n=58 uninsured Hispanic adults with type 2 diabetes; 12-month open-label randomised controlled trial at a single nonprofit community clinic in the USA, framed by the Consolidated Framework for Implementation Research. |
| Intervention | TIME programme (n=29): monthly community-health-worker-led group visits plus weekly CHW mHealth contact for 6 months (Action Phase), then quarterly visits plus bi-monthly mHealth contact for 6 months (Maintenance Phase), with tele-mentoring of the clinic team. |
| Comparison | Usual care (n=29) without the structured CHW, group-visit, or mHealth components. |
| Outcome | HbA1c change at 6 months: -0.85% (intervention) vs +0.35% (control), between-group difference 1.2 percentage points, p=.004. HbA1c change at 12 months: -0.52% vs +0.25%, difference 0.8 percentage points, p=.062 (not statistically significant). Preventive-care adherence favoured the intervention (p<.0001). Implementation measures: adoption 88.2% (844/957 CHW contacts), attrition 3.4%, acceptability 4.9/5.0, appropriateness 4.8/5.0, satisfaction 4.6/5.0. Reported net cost savings $16,435 ($566/participant). No 95% confidence intervals or NNT were reported. |
TIME diabetes programme in community care
RCT · type 2 diabetes · 12 months
TIME produced a larger HbA1c fall than usual care at 6 months, but the 12-month between-group difference was not statistically significant. A promising but underpowered single-site feasibility trial.
Expert Commentary
This is best read as an implementation-feasibility trial rather than a definitive efficacy study, and it should be judged on that basis. The design questions of acceptability, adoption, fidelity, and cost were addressed well, and the programme was clearly welcomed by patients and the clinic team. The headline glycaemic signal is more cautious than it first appears. A meaningful HbA1c separation was observed at 6 months while contact was intensive, but the difference narrowed and lost statistical significance by 12 months (p=.062), suggesting the early gain was not durably maintained once the schedule was tapered. The most important limitation is statistical power: with only 58 participants at a single site, the trial is too small to confirm a durable glycaemic benefit, and no confidence intervals were reported, so the precision of these estimates is unknown. The open-label design and the reliance on self-reported satisfaction surveys further temper the implementation findings, and the cost saving is a within-trial estimate that may not generalise. Can I use this with my patients? Not yet as proof of efficacy, though the model is promising for uninsured, underserved populations who lack access to structured diabetes care and warrants evaluation locally. A larger, multi-site trial powered for 12-month glycaemic outcomes is needed before this programme is adopted as established practice.
References
Vaughan EM, Yu X, Cardenas VJ, Johnston CA, Virani SS, Balasubramanyam A, et al. From Trials to Practice: Implementing a Clinical Intervention in Community Settings. J Prim Care Community Health. 2025;16:21501319251339190. doi:10.1177/21501319251339190
