Assessment of the features of follow-up and implementation of treatment and preventive measures in patients with prediabetes in outpatient clinical practice in the Russian Federation (DIORAMA): rationale and study design

Aim . To assess the features of clinical follow-up (dispensary observation) and the implementation of preventive measures among patients with prediabetes in the context of outpatient clinical practice. Material and methods . The DIORAMA study (Features of dispensary observation and implementation of therapeutic and preventive measures in patients with “prediabetes” in outpatient clinical practice) is a multicenter, open-label, prospective, observational study planned to be conducted in 200 medical institutions across the Russian Federation, with up to 24,000 participants. The study will include adult patients with confirmed prediabetes (ICD-10 codes: R73.0 — impaired glucose tolerance and/or R73.9 — unspecified hyperglycemia, including impaired fasting glucose). The observation period will last for at least three years, with data collection at baseline, and at 1- and 2-year follow-ups. Data collected will include demographic, clinical, lifestyle anthropometric, laboratory, and instrumental parameters, as well as details on therapeutic interventions and their effectiveness over time. Additional tools will include the FINDRISC questionnaire and treatment adherence surveys. The primary endpoints are normalization of carbohydrate metabolism parameters and progression to type 2 diabetes mellitus (T2DM). Secondary endpoints include cardiovascular and all-cause mortality, incidence of myocardial infarction, stroke, acute coronary syndrome, and emergency myocardial revascularization. Results . This study will examine real-world data pertaining to patients with prediabetes, focusing on patterns of care delivery — specifically, visit frequency and the deployment of therapeutic and preventive measures — and their effectiveness. The analysis is designed to evaluate laboratory parameters and modifiable risk factors, track progression to T2DM, and assess the influence of lifestyle, adherence, and therapeutic regimens on clinical endpoints. Conclusion . The DIORAMA study is expected to provide, for the first time at the national level, a systematic overview of follow-up, therapeutic, and preventive measures for prediabetes in the Russian Federation. The findings will have high practical significance for developing organizational and methodological algorithms aimed at optimizing outpatient care, improving patient adherence to treatment, and reducing the risk of progression from prediabetes to T2DM.