The value of patient-reported outcomes in patients with type 2 diabetes mellitus receiving insulin therapy: assessment of quality of life and hypoglycemia problems

Aim.

To study quality of life (QoL) and hypoglycaemic symptoms in patients with type 2 diabetes receiving intensive insulin therapy.

Materials and methods.

One thousand patients with type 2 diabetes receiving intensive insulin therapy for at least 6 months were enrolled in this multicenter observational study. The mean age of patients was 61.1 years (range, 29–84 years) and the male/female ratio was 265/735. All patients completed the SF-36® questionnaire and the Comprehensive Symptom Profile-Diabetes Mellitus Hypoglycemia Module. For group comparisons, we used unpaired t-tests or Mann–Whitney tests and general linear models. To compare categorical variables, the χ2 test and Fisher’s exact test were used.

Results.

The patients with type 2 diabetes receiving intensive insulin therapy demonstrated heterogeneity in terms of QoL. More than half of the patients had mild QoL impartment while nearly one third experienced significant QoL impairment. The following factors had the most pronounced negative impact on QoL: late diabetic complications, concomitant diseases, poor glycemic control and type of hypoglycaemia. QoL parameters were lower in patients with hypoglycaemic episodes than in those without (p <0.01), but in patients with mild hypoglycaemia it was similar to those without. The most pronounced disturbances in QoL occurred in patients with severe and nocturnal hypoglycaemia (p <0.05). The hypoglycaemic symptoms with the greatest burden on QoL were dizziness, morning weakness, eye problems, nightmares or crying out during sleep, distress, loss of energy and sleep disturbances. Correlation between the severity of fear of hypoglycaemia and QoL was also demonstrated. Higher the fear of hypoglycaemia, the more impaired was social functioning, mental health, vitality and general health.

Conclusion.

Assessment of QoL and hypoglycaemic symptoms in patients with type 2 diabetes receiving intensive insulin therapy reveals the need for a patient-centred approach in treatment and for a comprehensive evaluation of treatment outcomes.

1. Anderson RT, Narayan KM, Feeney P, et al. Effect of intensive glycemic lowering on health-related quality of life in type 2 diabetes: ACCORD trial. Diabetes Care. 2011; 34(4): 807–812. doi: 10.2337/dc10-1926

2. Solli O, Stavem K, Kristiansen IS. Health-related quality of life in diabetes: The associations of complications with EQ-5D scores. Health Qual Life Outcomes. 2010;8:18. doi: 10.1186/1477-7525-8-18

3. Lindsay G, Inverarity K, McDowell JRS. Quality of Life in People with Type 2 Diabetes in Relation to Deprivation, Gender, and Age in a New Community-Based Model of Care. Nurs Res Pract. 2011;2011:613589. doi: 10.1155/2011/613589

4. Сунцов Ю.И., Маслова О.В. Эпидемиология сахарного диабета. В кн: Сахарный диабет. Диагностика, лечение, профилактика. / Под ред. Дедова И.И., Шестаковой М.В. – М.: Медицинское информационное агентство; 2011. [Suntsov YI, Maslova OV. Epidemiology of diabetes mellitus.In: Diabetes mellitus. diagnosis; treatment; prevention. Ed by Dedov II, Shestakova MV. Moscow: Meditsinskoe informatsionnoe agentstvo; 2011. (In Russ.)]

5. Суркова Е.В., Анциферов М.Б., Майоров А.Ю. Качество жизни как важнейший показатель эффективности лечения сахарного диабета в XXI веке. // Сахарный диабет. – 2000. – Т. 3. – №1 – С.23–25. [Surkova EV, Antsiferov MB, Mayorov AY. Kachestvo zhizni kak vazhneyshiy pokazatel' effektivnosti lecheniya sakharnogo diabeta v XXI veke. Diabetes mellitus. 2000;3(1):23-25. (In Russ.)] doi: 10.14341/2072-0351-5739

6. Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of Hyperglycemia in Type 2 Diabetes: A Patient-Centered Approach. Diabetes Care. 2012;35(6):1364-1379. doi: 10.2337/dc12-0413

7. US Food and Drug Administration. Guidance for industry: patient-reported outcome measures; use in medical product development to support labeling claims. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071975.pdf

8. Новик А.А., Ионова Т.И. Руководство по исследованию качества жизни в медицине. 3-е изд., переработанное и дополненное. / Под ред. академика РАМН Шевченко Ю.Л. – М.: РАЕН; 2012. [Novik AA, Ionova TI. Guide to the study of quality of life in medicine. 3rd ed. Ed by academician Shevchenko Y.L. Moscow: RAEN; 2012. (In Russ.)]

9. Coons SJ, Rao S, Keininger DL, et al. A comparative review of quality-of-life instruments. Pharmacoeconomics. 2000;17(1): 13–35. doi: 10.2165/00019053-200017010-00002

10. Luscombe FA. Health-related quality of measurement in type 2 diabetes. Value Health. 2000;3 Suppl 1:15-28. doi: 10.1046/j.1524-4733.2000.36032.x

11. Bradley C. Measuring quality of life in diabetes. The Diabetes Annual. 1996;10:207–224.

12. Garratt AM, Schmidt L, Fitzpatrick R. Patient-assessed health outcome for measures for diabetes: a structured review. Diabet Med. 2002;19(1):1–11. doi: 10.1046/j.1464-5491.2002.00650.x

13. Дедов И.И., Шестакова М.В. Оптимизация и интенсификация инсулинотерапии при сахарном диабете 2 типа (клинические рекомендации). // Сахарный диабет. – 2010. – Т. 13. – №5 – С. 9-16. [Dedov II, Shestakova MV, Abusuev SA, et al. Optimizatsiya i intensifikatsiya insulinoterapii pri sakharnom diabete 2 tipa (klinicheskie rekomendatsii). Diabetes mellitus. 2010;13(5):9-16. (In Russ.)] doi: 10.14341/2072-0351-6049

14. Nyenwe EA, Jerkins TW, Umpierrez GE, et al. Management of type 2 diabetes: evolving strategies for the treatment of patients with type 2 diabetes. Metabolism. 2011;60(1):1-23. doi: 10.1016/j.metabol.2010.09.010

15. Houlden R, Ross S, Harris S, et al. Treatment satisfaction and quality of life using an early insulinization strategy with insulin glargine compared to an adjusted oral therapy in the management of type 2 diabetes: The Canadian INSIGHT study. Diabetes Res Clin Pract. 2007;78(2):254-258. doi: 10.1016/j.diabres.2007.03.021

16. Vinik A, Zhang Q. Adding insulin glargine versus rosiglitazone: Health-related quality-of-life impact in type 2 diabetes. Diabetes Care. 2007;30(4):795-800. doi: 10.2337/dc06-1712

17. Donnelly LA, Morris AD, Frier BM, et al. The DARTS/MEMO Collaboration: Frequency and predictors of hypoglycaemia in type 1 and insulin-treated type 2 diabetes: a population-based study. Diabet Med. 2005;22(6):749-755. doi: 10.1111/j.1464-5491.2005.01501.x

18. Henderson JN, Allen KV, Deary IJ, et al. Hypoglycaemia in insulin-treated Type 2 diabetes: frequency, symptoms and impaired awareness. Diabetes UK. Diabet Med. 2003;20(12):1016-1021. doi: 10.1046/j.1464-5491.2003.01072.x

19. Мельникова О.Г., Майоров А.Ю. Клинические и психологические аспекты гипогликемии при сахарном диабете. // Сахарный диабет. – 2010. – Т. 13. – №3 – С.46–50. [Mel'nikova OG, Mayorov AY. Clinical and psychological aspects of hypoglycemia in patients with diabetes mellitus. Diabetes mellitus. 2010;13(3):46-50. (In Russ.)] doi: 10.14341/2072-0351-5487

20. Патракеева Е.М., Дуничева М.Н., Залевская А.Г. Страх гипогликемии у пациентов с сахарным диабетом 1 типа. // Сахарный диабет. – 2014. – Т. 17. – №2 – С.66–75. [Patrakeeva EM, Dunicheva MN, Zalevskaya AG. Fear of hypoglycaemia in patients with type 1 diabetes. Diabetes mellitus. 2014;17(2):66-75. (In Russ.)] doi: 10.14341/DM2014266-75

21. Старостина Е.Г., Мошняга Е.Н. Фобии гипогликемий и их клиническое значение: исследование по типу «случай – контроль». // Сахарный диабет. – 2013. – Т. 16. – №3 – С.46–51. [Starostina EG, Moshnyaga EN. Fear of hypoglycemia and its clinical significance: a case-control study. Diabetes mellitus. 2013;16(3):46-51. (In Russ.)] doi: 10.14341/2072-0351-817

22. Ware JE, Sherbourne CD. The MOS 36-item short form health survey (SF-36): conceptual framework and item selection. Med Care. 1992;30(6):473-483. doi: 10.1097/00005650-199206000-00002

23. Ionova T, Nikitina T, Kurbatova K. Applicability of the new instrument for assessment of hypoglycemia symptoms in diabetes mellitus patients. Value in Health. 2014; 17(3):A256. doi: 10.1016/j.jval.2014.03.1491

24. Один В.И. Аутоиммунный сахарный диабет. // Под ред. Новика А.А. – СПб.: ВМедА; 2003. [Odin VI. Autoimmune diabetes. Ed Novick AA. Saint-Petersburg: The military medical Academy; 2003.]

25. Martin K,Bégaud B, Latry P, et al. Differences between clinical trials and postmarketing use. Br J Clin Pharmacol. 2004;57(1):86-92. doi: 10.1046/j.1365-2125.2003.01953.x

26. Новик А.А. От концепции исследования качества жизни к теории принятия решения в клинической практике. // Вестник Межнационального центра исследования качества жизни. – 2006. – №7–8 – С.7-8. [Novik AA. From the concept of quality of life studies to the theory of decision making in clinical practice. Bulletin of the international centre for the study of quality of life. 2006;(7-8):7-8. (In Russ.)]

27. Rubin RR, Peyrot M. Quality of life and diabetes. Diabetes Metab Res Rev. 1999;15(3):205-218. doi: 10.1002/(SICI)1520-7560(199905/06)15:3<205::AID-DMRR29>3.0.CO;2-O

28. Wee HL, Cheung YB, Li SC, et al. The impact of diabetes mellitus and other chronic medical conditions on health-related Quality of Life: Is the whole greater than the sum of its parts? Health Qual Life Outcomes. 2005;3:2. doi: 10.1186/1477-7525-3-2

29. Wexler DJ, Grant RW, Wittenberg E, et al. Correlates of health related quality of life in type 2 diabetes. Diabetologia. 2006;49(7):1489-1497. doi: 10.1007/s00125-006-0249-9

30. UK Prospective Diabetes Study Group. Quality of life in type 2 diabetic patients is affected by complications but not by intensive policies to improve blood glucose or blood pressure control (UKPDS 37). Diabetes Care. 1999;22(7):1125-1136. doi: 10.2337/diacare.22.7.1125

31. Верткин А.Л., Магомедова А.Ю., Казарцева С.С., и др. Клиническое и прогностическое значение гипогликемии у больных сахарным диабетом 2 типа. // Российский медицинский журнал. – 2012. – №13 – С. 651–655. [Vertkin AL, Magomedova AYU, Kazartseva SS, et al. Clinical and prognostic significance of hypoglycemia in patients with type 2 diabetes. Rossiyskiy meditsinskiy zhurnal. 2012;(13):651-655. (In Russ.)]

32. Мохорт Т.В. Гипогликемии и сахарный диабет 2-го типа: влияние на прогноз. // Медицинские новости. – 2011. – №3 – С.30-35. [Mohort TV. Hypoglycemia and diabetes mellitus of the 2nd type: influence on prognosis. Meditsinskie novosti. 2011; 3: 30-35. (In Russ.)]

33. Shafiee G, Mohajeri-Tehran M, Pajouhi P, et al. The importance of hypoglycemia in diabetic patients. J Diabetes Metab Disord. 2012;11(1):17. doi: 10.1186/2251-6581-11-17