Precision medicine to Redefine Insulin Secretion and Monogenic diabetes (PRISM) – A Randomised controlled trial in Chinese Patients with young-onset diabetes

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Objective Young-onset type 2 diabetes (YOD) is due to complex causes calling for precision management. Research Design and Methods The PRISM study is a single-centre, two-arm, three-year randomised controlled trial where Chinese individuals aged 18-50, with non-type 1 diabetes diagnosed at age≤40, were randomised to intervention (JADE-PRISM) or usual clinic-based care (JADE-only). The intervention included technologically-guided assessment and use of biogenetic markers (autoantibodies, C-peptide, common/rare genetic variants) to classify diabetes for one-year intensified, algorithm-based treatment followed by two annual reviews by an endocrinologist-led multidisciplinary team. Primary endpoint was composite of incident or progression of all diabetes-related complications. Secondary endpoints included attainment of ≥three treatment targets (HbA1c<6·2%, blood pressure<120/75 mmHg, LDL-cholesterol<1·2 mmol/L, triglyceride <1·2 mmol/L, waist<80 cm (women) or <85 cm (men)), proxies of beta-cell function and patient-reported-outcome measures (PROMs). Results In 2020-2021, 884 participants [mean (SD) age: 40·7 (6·5), mean age-at-diagnosis: 32·5 (6·8), autoantibodies-positive (n=46), monogenic diabetes (n=23), C peptide<200 pmol/L (n=82), central obesity (n=699), dyslipidaemia (n=669), hypertension (n=588), albuminuria (n=313), insulin-treated (n=250)] were randomised to JADE-PRISM (n=441) or JADE-only group (n=443). During the three-year study, primary endpoint developed in 116 participants (26·3%) in JADE-PRISM group versus 125 (28·2%) participants in JADE-only group (odds ratio 0·908 [95% CI: 0·675-1·221]). In JADE-PRISM group, 104 participants (23·8%) versus 54 participants in JADE-only group (12·2% p<0.001) attained ≥three treatment targets with improved proxies of beta-cell function and reduced emotional distress. Conclusion A three-year technology-enhanced, multicomponent programme improved cardiometabolic status, proxies of beta-cell function and PROMs in YOD but did not reduce complications.

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