Summary: In adults at risk of type 2 diabetes in Spanish primary care, the PREDIABETEXT pragmatic cluster randomised trial reported its intervention design, virtual recruitment strategy, and participants’ baseline characteristics, not efficacy. The team enrolled 58 of 133 healthcare professionals (43.6%) across 16 centres and 365 of 976 invited patients (37.4%), concluding only that a representative sample was successfully recruited.
PICO Summary
| Element | Detail |
|---|---|
| Population | Adults at risk of type 2 diabetes in primary care, Mallorca (Balearic Islands), Spain; 365 patients enrolled (54.5% women; mean age 59.82 years, SD 9.77) plus 58 healthcare professionals (30 doctors, 28 nurses) from 16 centres. Pragmatic, cluster randomised clinical trial; this report covers design, recruitment, and baseline data only. |
| Intervention | Multifaceted digital programme: personalised short text messages (SMS) supporting lifestyle behaviour change for at-risk patients, plus online training for their primary healthcare professionals. (Allocation, arm sizes, and effect on outcomes not reported in this paper.) |
| Comparison | Usual primary care, per the trial design. No between-arm comparison was performed or reported in this design and baseline paper. |
| Outcome | No efficacy outcomes reported. Recruitment yield: professionals 58/133 (43.6%), patients 365/976 (37.4%). Patient baseline burden: 55.3% BMI greater than or equal to 25, 65% hypertension, 43.3% hypercholesterolaemia, 14.8% hypertriglyceridaemia. No effect sizes, confidence intervals, p-values, ARR, or NNT are available, as no comparative or efficacy analysis was undertaken. |
Expert Commentary
This paper is best read for what it is, a transparent design, recruitment, and baseline-characteristics report for the PREDIABETEXT pragmatic cluster randomised trial, and not as evidence that a digital tool prevents type 2 diabetes. No efficacy data are presented, so any claim of improved lifestyle or reduced incidence would be premature and is not supported by these results. The value here is methodological. Virtual recruitment yielded 43.6% of professionals and 37.4% of patients, and the enrolled sample carried a substantial cardiometabolic burden, which speaks to external validity for a real-world prevention population. The main limitation is intrinsic to the publication type: with no comparator analysis, no significance testing, and a self-described pragmatic design that is unblinded by nature, conclusions about benefit must wait for the outcomes paper. Can I use this with my patients? Not yet. There is no measured effect to act on, though clinicians designing SMS-based prevention programmes may find the recruitment strategy and baseline profile genuinely useful for planning. I would encourage readers to watch for the forthcoming primary-outcome publication, ideally reporting glycaemic and behavioural endpoints with confidence intervals, before drawing any practice conclusions. Funding appears to be public and academic, which is reassuring, but it does not substitute for outcome data.
References
Mira-Martinez S, Zamanillo-Campos R, Malih N, et al. Describing the initial results of a pragmatic, cluster randomized clinical trial to examine the impact of a multifaceted digital intervention for the prevention of type 2 diabetes mellitus in the primary care setting: intervention design, recruitment strategy and participants’ baseline characteristics of the PREDIABETEXT trial. Front Endocrinol (Lausanne). 2025;16:1524336. doi:10.3389/fendo.2025.1524336