Precision Medicine to Redefine Insulin Secretion and Monogenic Diabetes (PRISM): A Randomized Controlled Trial in Chinese Patients With Young-Onset Diabetes
Abstract
Objective: Young-onset type 2 diabetes (YOD) results from complex causes, calling for precision management.
Research design and methods: The Precision Medicine to Redefine Insulin Secretion and Monogenic Diabetes (PRISM) study was a single-center, two-arm, 3-year randomized controlled trial in which Chinese individuals aged 18 to 50 years with non-type 1 diabetes diagnosed at age ≤40 years were randomly assigned to intervention (Joint Asia Diabetes Evaluation [JADE]-PRISM) or usual clinic-based care (JADE only). The intervention included technologically guided assessment and use of biogenetic markers (autoantibodies, C-peptide, and common and rare genetic variants) to classify diabetes for 1-year intensified, algorithm-based treatment followed by two annual reviews by an endocrinologist-led multidisciplinary team. The primary end point was a composite of incident or progression of all diabetes-related complications. Secondary end points included attainment of three or more treatment targets (HbA1c <6.2%, blood pressure <120/75 mmHg, LDL cholesterol <1.2 mmol/L, triglycerides <1.2 mmol/L, and waist circumference <80 [women] or <85 cm [men]), proxies of β-cell function, and patient-reported outcome measures (PROMs).
Results: During 2020 to 2021, 884 participants (mean [SD] age 40.7 [6.5] years; mean [SD] age at diagnosis 32.5 [6.8] years; autoantibody positivity [n = 46]; monogenic diabetes [n = 23]; C-peptide <200 pmol/L [n = 82]; central obesity [n = 699]; dyslipidemia [n =…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 699 participants or records.
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