Registry-based randomised clinical trials: a remedy for evidence-based diabetes care? – published online 29/07/2022

Jan W. Eriksson, Björn Eliasson, Louise Bennet, Johan Sundström

Over recent years, registry-based randomised clinical trials (RRCT) have been used in some clinical conditions, for example within cardiology and orthopaedic surgery. In both type 1 and type 2 diabetes, there are several examples of observational studies based on registries or established cohorts that evaluate treatment effects; however, to date, no RRCTs have been performed. In this issue, Eriksson et al (https://doi.org/10.1007/s00125-022-05762-x) review how pragmatic large-scale clinical trials could be applied in the diabetes area. The authors propose that both academic and industry sponsors should consider this highly cost-effective and robust design for future large-scale diabetes trials. Following allocation to randomised treatment, the participants’ outcome data are collected from established healthcare registries or potentially from other well-defined cohort databases. The authors outline the pros and cons of RRCTs compared with traditional RCTs. The first RRCT in diabetes is briefly described, namely the ongoing SMARTEST trial, which is evaluating the effects of monotherapy with a sodium–glucose cotransporter 2 (SGLT2) inhibitor vs metformin to prevent macro- and microvascular events and premature death in patients with early-stage type 2 diabetes. The authors conclude that RRCTs in diabetes could enable the rapid recruitment of large cohorts with broad coverage of both geographical and disease subgroups and provide robust endpoint data at very low cost. The figures from this review are available as a downloadable slideset.

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