Open Access Journal of Clinical Trials (Jun 2016)
An international, multicenter, observational survey to evaluate diabetes control in subjects using insulin for the treatment of type 1 and type 2 diabetes mellitus in the Czech Republic and Slovak Republic: study protocol for a cross-sectional survey
Abstract
Jan Brož,1 Denisa Janickova Zdarska,1 Jana Urbanova,2 Marek Brabec,3 Bohumila Krivska,4 Viera Donicova,5 Radka Stepanova,6 Emil Martinka,7 Milan Kvapil1 1Department of Internal Medicine, Second Faculty of Medicine, 2Center for Research on Diabetes, Metabolism and Nutrition, Second Department of Internal Medicine, Third Faculty of Medicine, Charles University, 3Institute of Computer Science of the ASCR, vvi, 4Sanofi, Prague, Czech Republic; 5Private Department of Diabetology, Internal Medicine and Metabolism, Kosice, Slovak Republic; 6ADDS sro, Brno, Czech Republic; 7National Institute of Endocrinology and Diabetology, Lubochna, Slovak Republic Background: Despite the improvements in insulin therapy, a large number of patients fail to achieve their target glycated hemoglobin (HbA1c) levels. Control of diabetes is often unsatisfactory because the patient does not know about the principles of successful insulin therapy (ie, blood glucose self-monitoring, the principles of insulin administration, titration, current dose adjustments, dietary recommendations, and physical activity preventive measures) or because these principles are applied incorrectly or insufficiently. Furthermore, the fear of hypoglycemia may lead to maintaining higher than recommended blood glucose levels. Methods/design: This is a noninterventional, international study focusing on a questionnaire survey of diabetes patients (patient-reported outcome) treated with insulin for at least 1 year. It is designed so that the data obtained reflect real access of patients to insulin treatment. The primary objective is to show the results of glycemic control of diabetes (HbA1c) achieved in diabetes patients treated with at least one dose of insulin. The secondary objective is to monitor the factors potentially affecting these results, which include the frequency and other characteristics of hypoglycemia, the frequency of blood glucose self-monitoring, and the effects produced when the results are employed in adjusting the therapy. Furthermore, the study investigates factors related to the principles of insulin administration, dietary regime, and exercise habits. The study will enroll a total of 1,500 patients with type 1 and type 2 diabetes in 150 centers: two-thirds in the Czech Republic and one-third in the Slovak Republic. Discussion: The study is primarily aimed at determining the percentage of insulin-treated diabetes patients reaching the recommended targets for glycemic control (HbA1c). Furthermore, it attempts to identify and describe in detail the factors of failure in achieving the therapeutic goals. An analysis of the data thus obtained may result in recommendations on how to reduce and eliminate all the identified negative factors in the future. Keywords: insulin therapy, glycemic control, HbA1c, hypoglycemia, education, diabetes regimen adherence
