INTRODUCTION: The aim of this study was to determine the level of awareness of hypoglycemia, the level of fear for hypoglycemia, and the response to hypoglycemic events among insulin-treated diabetes patients from Central and Eastern Europe (CEE). The impact of hypoglycemia on the use of healthcare resources and patient productivity was also assessed. METHODS: This was a multicenter, non-interventional, two-part, patient self-reported questionnaire study that comprised both a retrospective cross-sectional evaluation and a prospective observational evaluation. Study participants were insulin-treated adult patients with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) from CEE. RESULTS: Most patients (85.4% T1DM and 83.6% T2DM) reported normal hypoglycemia awareness. The median hypoglycemia fear score was 5 out of 10 for T1DM and 4 out of 10 for T2DM patients. Patients increased glucose monitoring, consulted a doctor/nurse, and/or reduced the insulin dose in response to hypoglycemia. As a consequence of hypoglycemia, patients took leave from work/studies or arrived late and/or left early. Hospitalization was required for 31 (1.2%) patients with T1DM and 66 (2.1%) patients with T2DM. CONCLUSION: Hypoglycemia impacts patients' personal and social functioning, reduces productivity, and results in additional costs, both direct (related to increased use of healthcare resources) and indirect (related to absenteeism. FUNDING: Novo Nordisk.

1st Department of Medicine Faculty of Medicine Semmelweis University Budapest Hungary

1st Department of Pediatrics Faculty of Medicine Semmelweis University Budapest Budapest Hungary

Center for Research of Nutrition Metabolism and Diabetes 3rd Faculty of Medicine Charles University Prague Czech Republic

Clinic for Endocrinology Diabetes and Metabolic Diseases Clinical Center of Serbia Faculty of Medicine University of Belgrade Belgrade Serbia

Clinic of Endocrinology and Metabolism Department of Internal Medicine University Hospital Alexandrovska Medical University Sofia Sofia Bulgaria

Clinical Center of Endocrinology Medical University Sofia Sofia Bulgaria

Department of Diabetology and Internal Medicine Medical University of Warsaw Warsaw Poland

Department of Endocrinology Diabetes and Metabolic Diseases University Medical Center Ljubljana Slovenia

Department of Endocrinology Diabetology and Internal Diseases Medical University of Białystok Białystok Poland

Department of Internal Diseases Diabetology and Cardiometabolic Diseases School of Medicine with the Division of Dentistry in Zabrze Medical University of Silesia Katowice Poland

Diabetes Centre and Centre for Experimental Medicine Institute for Clinical and Experimental Medicine Vídeňská 1958 9 140 21 Prague 4 Czech Republic

Novo Nordisk Pharma Warsaw Poland

Vuk Vrhovac University Clinic for Diabetes UH Merkur School of Medicine University of Zagreb Zagreb Croatia

Zobrazit více v PubMed

American Diabetes Association Standards of medical care in diabetes—2017. Diabetes Care. 2017;40(Suppl 1):S1–S135. PubMed

Action to Control Cardiovascular Risk in Diabetes Study Group. Gerstein HC, Miller ME, et al. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008;358(24):2545–2559. doi: 10.1056/NEJMoa0802743. PubMed DOI PMC

Zoungas S, Patel A, Chalmers J, et al. Severe hypoglycaemia and risks of vascular events and death. N Engl J Med. 2010;363(15):1410–1418. doi: 10.1056/NEJMoa1003795. PubMed DOI

Desouza CV, Bolli GB, Fonseca V. Hypoglycaemia, diabetes and cardiovascular events. Diabetes Care. 2010;33(6):1389–1394. doi: 10.2337/dc09-2082. PubMed DOI PMC

Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, Mattheus M, Devins T, Johansen OE, Woerle HJ, Broedl UC, Inzucchi SE. EMPA-REG OUTCOME Investigators. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015;373(22):2117–28. doi: 10.1056/NEJMoa1504720. PubMed DOI

Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2016;375(4):311–322. doi: 10.1056/NEJMoa1603827. PubMed DOI PMC

Yaffe K, Falvey CM, Hamilton N, et al. Association between hypoglycaemia and dementia in a biracial cohort of older adults with diabetes mellitus. JAMA Intern Med. 2013;173(14):1300–1306. doi: 10.1001/jamainternmed.2013.6176. PubMed DOI PMC

Vexiau P, Mavros P, Krishnarajah G, Lyu R, Yin D. Hypoglycaemia in patients with type 2 diabetes treated with a combination of metformin and sulphonylurea therapy in France. Diabetes Obes Metab. 2008;10(Suppl 1):16–24. doi: 10.1111/j.1463-1326.2008.00883.x. PubMed DOI

Frier BM. How hypoglycaemia can affect the life of a person with diabetes. Diabetes Metab Res Rev. 2008;24(2):87–92. doi: 10.1002/dmrr.796. PubMed DOI

Seaquist ER, Anderson J, Childs B, et al. Hypoglycemia and diabetes: a report of a workgroup of the American Diabetes Association and the Endocrine Society. Diabetes Care. 2013;36(5):1384–1395. doi: 10.2337/dc12-2480. PubMed DOI PMC

Östenson CG, Geelhoed-Duijvestijn P, Lahtela J, Weitgasser R, Markert Jensen M, Pedersen-Bjergaard U. Self-reported non-severe hypoglycaemic events in Europe. Diabet Med. 2014;31(1):92–101. doi: 10.1111/dme.12261. PubMed DOI PMC

Kenny C. When hypoglycemia is not obvious: diagnosing and treating under-recognized and undisclosed hypoglycemia. Prim Care Diabetes. 2014;8(1):3–11. doi: 10.1016/j.pcd.2013.09.002. PubMed DOI

Khunti K, Alsifri S, Aronson R, et al. Rates and predictors of hypoglycaemia in 27 585 people from 24 countries with insulin-treated type 1 and type 2 diabetes: the global HAT study. Diabetes Obes Metab. 2016;18(9):907–915. doi: 10.1111/dom.12689. PubMed DOI PMC

Brath H, Paldánius PM, Bader G, Kolaczynski WM, Nilsson PM. Differences in glycemic control across world regions: a post-hoc analysis in patients with type 2 diabetes mellitus on dual antidiabetes drug therapy. Nutr Diabetes. 2016;6(7):e217M. doi: 10.1038/nutd.2016.25. PubMed DOI PMC

American Diabetes Association Standards of medical care in diabetes—2015. Diabetes Care. 2015;38(Suppl 1):S1–S93. PubMed

Workgroup on Hypoglycemia, American Diabetes Association Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care. 2005;28(5):1245–1249. doi: 10.2337/diacare.28.5.1245. PubMed DOI

Wohland T, Holstein JD, Patzer OM, et al. New risk and protective factors for severe hypoglycaemia in people with type 1 diabetes. Nutr Metab Cardiovasc Dis. 2017 PubMed

Geddes J, Schopman JE, Zammitt NN, Frier BM. Prevalence of impaired awareness of hypoglycaemia in adults with type 1 diabetes. Diabet Med. 2008;25(4):501–504. doi: 10.1111/j.1464-5491.2008.02413.x. PubMed DOI

Hendrieckx C, Hagger V, Jenkins A, Skinner TC, Pouwer F, Speight J. Severe hypoglycemia, impaired awareness of hypoglycemia, and self-monitoring in adults with type 1 diabetes: results from Diabetes MILES-Australia. J Diabetes Complications. 2017;31(3):577–582. doi: 10.1016/j.jdiacomp.2016.11.013. PubMed DOI

Weitgasser R, Lopes S. Self-reported frequency and impact of hypoglycaemic events in insulin-treated diabetic patients in Austria. Wien Klin Wochenschr. 2015;127(1–2):36–44. doi: 10.1007/s00508-014-0626-1. PubMed DOI PMC

Peene B, D’Hooge D, Vandebrouck T, Mathieu C. Patient-reported frequency, awareness and patient-physician communication of hypoglycaemia in Belgium. Acta Clin Belg. 2014;69(6):439–445. doi: 10.1179/2295333714Y.0000000050. PubMed DOI

Kulzer B, Seitz L, Kern W. Real-world patient-reported rates of non-severe hypoglycaemic events in Germany. Exp Clin Endocrinol Diabetes. 2014;122(3):167–172. doi: 10.1055/s-0033-1363688. PubMed DOI

Schopman JE, Geddes J, Frier BM. Prevalence of impaired awareness of hypoglycaemia and frequency of hypoglycaemia in insulin-treated type 2 diabetes. Diabetes Res Clin Pract. 2010;87(1):64–68. doi: 10.1016/j.diabres.2009.10.013. PubMed DOI

Gehlaut RR, Dogbey GY, Schwartz FL, Marling CR, Shubrook JH. Hypoglycemia in type 2 diabetes-more common than you think: a continuous glucose monitoring study. J Diabetes Sci Technol. 2015;9(5):999–1005. doi: 10.1177/1932296815581052. PubMed DOI PMC

Büyükkaya Besen D, Arda Sürücü H, Koşar C. Self-reported frequency, severity of, and awareness of hypoglycemia in type 2 diabetes patients in Turkey. PeerJ. 2016;4:e2700. doi: 10.7717/peerj.2700. PubMed DOI PMC

Pedersen-Bjergaard U, Pramming S, Thorsteinsson B. Recall of severe hypoglycaemia and self-estimated state of awareness in type 1 diabetes. Diabetes Metab Res Rev. 2003;19(3):232–240. doi: 10.1002/dmrr.377. PubMed DOI

Martyn-Nemeth P, Quinn L, Penckofer S, Park C, Hofer V, Burke L. Fear of hypoglycemia: influence on glycemic variability and self-management behavior in young adults with type 1 diabetes. J Diabetes Complications. 2017;31(4):735–741. doi: 10.1016/j.jdiacomp.2016.12.015. PubMed DOI PMC

Strandberg RB, Graue M, Wentzel-Larsen T, Peyrot M, Wahl AK, Rokne B. The relationships among fear of hypoglycaemia, diabetes-related quality of life and psychological well-being in Norwegian adults with Type 1 diabetes. Diabetes Res Clin Pract. 2017;124:11–19. doi: 10.1016/j.diabres.2016.12.018. PubMed DOI

Lopez JM, Annunziata K, Bailey RA, Rupnow MF, Morisky DE. Impact of hypoglycemia on patients with type 2 diabetes mellitus and their quality of life, work productivity, and medication adherence. Patient Prefer Adherence. 2014;8:683–692. doi: 10.2147/PPA.S58813. PubMed DOI PMC

Bron M, Marynchenko M, Yang H, Yu AP, Wu EQ. Hypoglycemia, treatment discontinuation, and costs in patients with type 2 diabetes mellitus on oral antidiabetic drugs. Postgrad Med. 2012;124(1):124–132. doi: 10.3810/pgm.2012.01.2525. PubMed DOI

Fulcher G, Singer J, Castañeda R, et al. The psychosocial and financial impact of non-severe hypoglycemic events on people with diabetes: two international surveys. J Med Econ. 2014;17(10):751–761. doi: 10.3111/13696998.2014.946992. PubMed DOI

Brod M, Wolden M, Groleau D, Bushnell DM. Understanding the economic, daily functioning, and diabetes management burden of non-severe nocturnal hypoglycemic events in Canada: differences between type 1 and type 2. J Med Econ. 2014;17(1):11–20. doi: 10.3111/13696998.2013.857676. PubMed DOI

Geelhoed-Duijvestijn PH, Pedersen-Bjergaard U, Weitgasser R, Lahtela J, Jensen MM, Östenson CG. Effects of patient-reported non-severe hypoglycemia on healthcare resource use, work-time loss, and wellbeing in insulin-treated patients with diabetes in seven European countries. J Med Econ. 2013;16(12):1453–1461. doi: 10.3111/13696998.2013.852098. PubMed DOI

Fidler C, Elmelund Christensen T, Gillard S. Hypoglycemia: an overview of fear of hypoglycemia, quality-of-life, and impact on costs. J Med Econ. 2011;14(5):646–655. doi: 10.3111/13696998.2011.610852. PubMed DOI

Widz K, Czech M, Hermanowski T. Cost of hypoglycaemia in patients with diabetes in Poland. PHS49. Value Health. 2012;15:A277–A575. doi: 10.1016/j.jval.2012.08.1822. DOI

Goldstein D, Chodick G, Shalev V, Thorsted BL, Elliott L, Karasik A. Use of healthcare services following severe hypoglycemia in patients with diabetes: analysis of real-world data. Diabetes Ther. 2016;7(2):295–308. doi: 10.1007/s13300-016-0169-8. PubMed DOI PMC

Jakubczyk M, Lipka I, Pawęska J, et al. Cost of severe hypoglycaemia in nine European countries. J Med Econ. 2016;19(10):973–982. doi: 10.1080/13696998.2016.1188823. PubMed DOI

Deshpande PR, Rajan S, Sudeepthi BL, Abdul Nazir CP. Patient-reported outcomes: a new era in clinical research. Perspect Clin Res. 2011;2(4):137–144. doi: 10.4103/2229-3485.86879. PubMed DOI PMC

Results of Insulin Therapy in Type 2 Diabetes Mellitus Patients in the Czech Republic: Do They Reflect the Current Status in Other Countries?