The Prevalence of Hypoglycemia and Its Impact on the Quality of Life of Type II Diabetes Mellitus Patients in Greece (The HYPO study)

Presentation Number: OR32-1
Date of Presentation: June 17th, 2013

Grigorios Rombopoulos*1, Magdalini Hatzikou2, Dimitra Latsou3 and John Yfantopoulos3
1Novartis Hellas SACI, Athens, Greece, 2Novartis Hellas, Metamorphosis, Greece, 3University of Athens

Abstract

BACKGROUND: Good glycemic control is a fundamental objective of the management of type 2 diabetes (T2DM) to minimize the risk of vascular complications of diabetes. However, strict glycemic control and intensification of therapy can increase the risk of hypoglycemia, especially for people treated with insulin or sulphonylureas.  Hypoglycemia results in neuroglycopenia, which causes cognitive impairment and mood change and may progress to behavioral changes, reduced consciousness, seizure and coma. Finally, hypoglycemia has negative impact on health care resources and patients’ quality of life (QoL).

OBJECTIVE: To estimate the impact of hypoglycemia on the QoL as well as its prevalence in T2DM  patients in Greece.

MATERIAL-METHOD: A cross-sectional epidemiological study was conducted in 6631 patients with T2DM, who were enrolled over a 6-month time period. The population was selected by random sampling following geographical distribution among Greece.  The ADDQoL-19 QoL instrument was self-administered and completed by each patient while information on patient demographics and medical history was collected by physicians specialized in diabetes. The psychometric properties of ADDQoL-19 were assessed for reliability and internal validity.  Patients’ categorization was based on the experience of hypoglycemia or not and controlled or uncontrolled T2DM.  Controlled patients were considered as having Hb1Ac< 7% and hypoglycemic episodes were defined as laboratory-confirmed clinically symptomatic events.  Odds ratios were calculated using logistic regression analysis.

RESULTS: The majority of the sample were male (55%) and overweight (59%). 20.4% of T2DM patients had a history of laboratory-confirmed hypoglycemia. 59% of the sample had HbA1c >7%.  The mean age was 60 years and the mean T2DM duration was about 10 years. The mean QoL score of the total sample was -3.1± 1.9 and the mean score of non-hypoglycemic patients was -3.05 ± 2.0 while the respective score of hypoglycemic patients was -3.26 ±1.8, (p≤0.005).  Similar results were observed in the group of controlled patients and uncontrolled patients, who scored -2.73±1.7 and -3.33±1.9, respectively (p≤0.005). 

Comparable results were identified in the majority of the ADDQoL-19 instruments’ dimensions. A statistically significant difference (p≤ 0.05) in the QoL was found between hypoglycemic and non-hypoglycemic patients and those being controlled and uncontrolled. According to the logistic regression analysis the majority of the ADDQoL-19 dimensions (10 out of 19) were significantly affected by hypoglycemia, as well as by high levels of HbA1c.

CONCLUSIONS: QoL of T2DM patients is affected significantly by hypoglycemic events and the level of the disease control. In diabetes treatment the ultimate goal should be the good glycemic control without debilitating hypoglycemic episodes which compromise patients’ QoL.

 

Disclosure: GR: Employee, Novartis Pharmaceuticals. MH: Employee, Novartis Pharmaceuticals. JY: Investigator, Novartis Pharmaceuticals. Nothing to Disclose: DL