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.

1. Tabák AG, Herder C, Rathmann W, et al. Prediabetes: a high-risk state for diabetes development. Lancet. 2012;379(9833):2279-90. DOI:10.1016/S0140-6736(12)60283-9.

2. Nicolaisen SK, Pedersen L, Witte DR, et al. HbA1c-defined prediabetes and progression to type 2 diabetes in Denmark: A population-based study based on routine clinical care laboratory data. Diabetes Res Clin Pract. 2023;203:110829. DOI:10.1016/j.diabres.2023.110829.

3. Drapkina OM, Svishcheva AA, Lavrenova EA, Shepel RN. Implementation of early detection programs for type 2 diabetes and dispensary observation of patients: international and Russian experience. Primary Health Care (RF). 2025;2(2):34-44. (In Russ.)

4. Drapkina OM, Mokrysheva NG, Shestakova MV, et al. Outpatient monitoring of patients with type 2 diabetes by a primary care physician. Guidelines. Primary Health Care (RF). 2025;2(2):98-134. (In Russ.)

5. Dedov II, Shestakova MV, Gagelgans RR. Prevalence of type 2 diabetes in the adult population of Russia (NATION study). Diabetes Mellitus. 2016;19(2):104-12. (In Russ.)

6. Balanova, YuA, Shalnova, SA, Imaeva, AE., et al. Prediabetes: prevalence, associations with cardiovascular risk factors and contribution to survival in a Russian population. Cardiovascular Therapy and Prevention. 2024;23(5):4022. (In Russ.)

7. Cai X, Zhang Y, Li M, et al. Association between prediabetes and risk of allcause mortality and cardiovascular disease: updated meta-analysis. BMJ. 2020;370:m2297. DOI:10.1136/bmj.m2297.

8. Huang Y, Cai X, Mai W, Li M. et al. Association between prediabetes and risk of cardiovascular disease and all-cause mortality: systematic review and allcause mortality: systematic review and meta-analysis. BMJ. 2016;355: i5953. DOI:10.1136/bmj.i5953.

9. Wong TY, Barr EL, Tapp RJ et al. Retinopathy in persons with impaired glucose metabolism: the Australian Diabetes Obesity and Lifestyle (AusDiab) study. Am J Ophthalmol. 2005;140(6):1157-9. DOI:10.1016/j.ajo.2005.07.030.

10. Kaneyama A, Hirata A, Hirata T, et al. Impact of hypertension and diabetes on the onset of chronic kidney disease in a general Japanese population. Hypertens Res. 2023; 46(2):311-20. DOI:10.1038/s41440-022-01041-9.

11. American Diabetes Association Professional Practice Committee. Summary of Revisions: Standards of Care in Diabetes-2025. Diabetes Care. 2025 Jan 1;48(1 Suppl 1):S6-S13. DOI:10.2337/dc25-SREV.

12. Dall TM, Yang W, Halder P et al. The economic burden of elevated blood glucose levels in 2012: diagnosed and undiagnosed diabetes, gestational diabetes mellitus, and prediabetes. Diabetes Care. 2014;37(12):3172-9. DOI:10.2337/dc14-1036.

13. O’Connell JM, Manson SM. Understanding the Economic Costs of Diabetes and Prediabetes and What We May Learn About Reducing the Health and Economic Burden of These Conditions. Diabetes Care. 2019;42(9):1609-11. DOI:10.2337/dci19-0017.

14. Rooney MR, Fang M, Ogurtsova K, et al. Global Prevalence of Prediabetes. Diabetes Care. 2023;46(7):1388-94. DOI:10.2337/dc22-2376.

15. GBD 2013 Mortality and Causes of Death Collaborators. Global, regional, and national age-sex specific all-cause and cause-specific mortality for 240 causes of death, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015;385(9963):117-71. DOI:10.1016/S0140-6736(14)61682-2.

16. Dedov II, Kontsevaya AV, Shestakova MV, et al. Economic costs of type 2 diabetes mellitus and its major cardiovascular complications in the Russian Federation. Diabetes Mellitus. 2016;19(6):518-27. (In Russ.)

17. Knowler WC, Barrett-Connor E, Fowler SE et al.; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002;346(6):393-403. DOI:10.1056/NEJMoa012512.

18. Drapkina OM, Drozdova LY, Shepel RN, et al. Prevalence of prediabetes and clinical practice of pharmacotherapy in prediabetic patients. Profilakticheskaya Meditsina. 2022;25(12):96-105. (In Russ.)