Revista Clínica Española (English Edition) Revista Clínica Española (English Edition)
Brief Original
Quality of life and fear for hypoglycemia in patients with type 2 diabetes mellitus
Calidad de vida y grado de preocupación por las hipoglucemias en pacientes con diabetes mellitus tipo 2
E. Jódar-Gimenoa,, , , F. Álvarez-Guisasolab, L. Ávila-Lachicac, R. Palomares-Ortegad, C. Roldán-Suáreze, L. Lizán-Tudelaf
a Servicio de Endocrinología y Nutrición, Hospital Universitario Quirón, Madrid, Universidad Europea de Madrid, Madrid, Spain
b Centro de Salud la Calzada II, Gijón, Asturias, Spain
c Consultorio Local El Borge, Málaga, Spain
d Servicio de Endocrinología y Nutrición, Hospital Reina Sofía, Córdoba, Spain
e Departamento Médico Novartis Farmacéutica S.A., Barcelona, Spain
f Outcomes’10, Universidad Jaume I, Castellón, Spain
Received 30 May 2014, Accepted 27 July 2014
Abstract
Objectives

Hypoglycemia can negatively impact many aspects of type 2 diabetes mellitus (T2DM) management. The aim was to determine the impact of hypoglycemia and the fear for hypoglycemic episodes on HRQoL in T2DM patients in Spain, as well as healthcare professionals’ attitudes and knowledge of these issues.

Patients and methods

An observational, cross-sectional study, with consecutive recruitment of T2DM patients in 661 healthcare centers, between September 2010 and May 2011. Sociodemographic and clinical variables were recorded. HRQoL (ADDQoL questionnaire) and fear for hypoglycemia (HFS-II) were evaluated. Two groups were compared: with and without reported hypoglycemia in the previous 6 months. Physicians responded 4 questions (visual analog scales).

Results

4.054 patients participated, of which 3812 were selected [mean age (SD)=64 (11) years; male=54%; 10 (7) years for diagnostic of T2DM]. Patients with hypoglycemia (45%) expressed higher fear for hypoglycemia [31.32 (15.71) vs. 18.85 (16.03); p<.0001] and the overall impact of T2DM on their HRQoL was more negative [−2.48 (1.61) vs. −1.64 (1.36); p<.001]. Respondent physicians occasionally used HRQoL questionnaires, knew about hypoglycemia risk, explored fear for hypoglycemia and modified treatments accordingly.

Conclusions

T2DM patients with hypoglycemia show an increase of fear for them, negatively affecting T2DM patients HRQoL. However physicians know the risk of hypoglycemia, they explore the fear for hypoglycemic episodes occasionally.

Resumen
Objetivos

Las hipoglucemias pueden tener un impacto negativo en diferentes aspectos del manejo de la diabetes mellitus tipo 2 (DM2). El objetivo fue determinar el impacto que las hipoglucemias y la preocupación que generan tienen en la calidad de vida relacionada con la salud (CVRS) de los pacientes con DM2 en España, así como explorar las actitudes y conocimientos de los médicos respecto a estos aspectos.

Pacientes y métodos

Estudio observacional, transversal, con reclutamiento consecutivo de pacientes con DM2 en 661 centros sanitarios, entre septiembre/2010 y mayo/2011. Se recogieron variables sociodemográficas y clínicas de los pacientes, evaluando su CVRS (cuestionario ADDQoL) y preocupación por las hipoglucemias (subescala HFS-II). Se compararon 2 grupos: con y sin hipoglucemias reportadas en los últimos 6 meses. Los médicos respondieron 4 cuestiones (escalas visuales analógicas).

Resultados

Participaron 4.054 pacientes, de los cuales se seleccionaron 3.812 [edad media (DE)=64 (11) años; hombres=54%; 10 (7) años de diagnóstico de DM2]. Los pacientes que reportaron hipoglucemias (45%) presentaron mayor preocupación [31,32 (15,71) frente a 18,85 (16,03); p<0,0001] y el impacto global de la DM2 sobre su CVRS fue más negativo [−2,48 (1,61) frente a −1,64 (1,36); p<0,001]. Los médicos encuestados empleaban ocasionalmente cuestionarios de CVRS, conocían el riesgo de hipoglucemias, exploraban con relativa frecuencia la preocupación que generan y modificaban esporádicamente el tratamiento debido a las mismas.

Conclusiones

Los pacientes con DM2 e hipoglucemias muestran mayor preocupación por las mismas, afectando negativamente su CVRS. Aunque los médicos conocen el riesgo de hipoglucemias, no suelen explorar la preocupación que generan.

Keywords
Health-related quality of life, Hypoglycemias, Type 2 diabetes mellitus
Palabras clave
Calidad de vida relacionada con la salud, Hipoglucemias, Diabetes mellitus tipo 2

What we know?

Hypoglycemia is a common complication for patients with type 2 diabetes mellitus (DM2) that affects their quality of life. There are no known studies conducted in Spain that have examined the fear of hypoglycemia and its influence on quality of life.

What this article provides?

Forty percent of more than 4000 patients with DM2 in Spain reported a hypoglycemic episode. Their quality of life was significantly lower than that of patients who reported no hypoglycemic episode. Doctors who treat these patients seriously consider hypoglycemic episodes but not their influence on the patients’ quality of life.

The Editors

Background

Patients with diabetes can become worried about hypoglycemia, which can have a negative impact on the management and evolution of the disease, thus limiting the effectiveness of hypoglycemic treatments,1,2 affecting treatment adherence and decreasing occupational productivity and autonomy.3 Previous studies have highlighted the change in their health-related quality of life (HRQL) as a result of the onset of treatment complications, such as hypoglycemia.4 Dietary treatment has been indicated by patients as having the greatest negative impact on their HRQL.5 Hypoglycemic symptoms, especially sweats, fatigue, drowsiness, lack of concentration, dizziness, hunger, asthenia and headache,6 are related to increased patient worry about these hypoglycemic episodes, with the resulting reduction in HRQL.7 Patients with serious and/or frequent hypoglycemia report greater fear of these episodes,8,9 which results in a loss of their occupational productivity and increased healthcare costs associated with the disease.10,11

The lack of studies that explore the relationship between worrying about hypoglycemia and the HRQL of patients with type 2 diabetes mellitus (DM2) in Spain demonstrates the need to generate information on this issue. There is also a notable lack of published data on the attitudes and knowledge of medical professionals in Spain in terms of HRQL, hypoglycemia and the worry it creates.

The main objective of this study has been to determine the impact of hypoglycemia episodes, the fear they create and the effect this can have on the HRQL of patients with DM2. We also explored the knowledge and attitudes of medical professionals regarding these issues.

Patients and methodsStudy description

We conducted an observational, cross-sectional study between September 2010 and May 2011, which counted on the participation of 661 primary and specialized care centers belonging to Spain's public healthcare system, proportionally distributed among 17 autonomous communities, selected by convenience sampling.

One investigator per center (73% primary care and 27% specialized care) participated in the study. The physician specialists who collaborated were distributed among the following specialties: endocrinology and nutrition, 18%; internal medicine, 8%; and other specialties, 1%. All physicians selected approximately 6 patients (by consecutive sampling) who met the following inclusion criteria: diagnosis of DM2 at least one year prior to their participation in the study, age ≥18 years and undergoing antidiabetic drug treatment. The exclusion criteria were the need to translate any of the study tools, participation in a clinical trial at the time of the study or having participated in a study in the 6 months prior to their inclusion and a clinical situation that prevents study participation, in the investigator's opinion. The data were collected during a single visit not specifically scheduled for the study (according to standard clinical practice).

The protocol and related documents were approved by the Ethics Committee for Clinical Research of the Hospital Clinic of Barcelona. All patients participating in the study received a study information sheet and signed the corresponding informed consent for participation before their inclusion.

Study instruments

The researchers collected the patients’ demographic and clinical characteristics (age, sex, employment status, height, weight, waist circumference, smoking habit, drinking habit, date of diagnosis, family history of DM2, microvascular and macrovascular complications, hospital admissions and emergency department visits associated with hypoglycemic episodes) by consulting their medical history. The patients completed the items concerning hypoglycemic episodes (presence or absence during the 6 months prior to inclusion in the study, number, frequency, severity and absence from work due to hypoglycemia in the last 6 months). To this end, the patient case report forms included the following definition of hypoglycemia: “The presence of low blood sugar levels that occur with discomfort that you probably notice, such as dizziness, lightheadedness, palpitations, cold sweats, tremors, nervousness, headache and voracious hunger. If your blood sugar levels fall significantly, you might experience drowsiness, confusion, behavioral disorders and even loss of consciousness.”

The patients also completed 2 questionnaires: the Audit of Diabetes-Dependent Quality-of-Life (ADDQoL)12 and the Worry Subscale of the Hypoglycemic Fear Survey-II (HFS-II).13 The specific ADDQoL questionnaire consists of 2 general items in which the patient scores their current overall quality of life (from −3=terrible to 3=excellent) and their quality of life if they had no diabetes (from 1=worse to −3=much better), respectively, as well as 19 specific items that explored the impact of diabetes on various aspects of life (from −9=maximum negative impact to 3=maximum positive impact). The mean score achieved on the 19 items indicates the mean impact of diabetes on the patients’ HRQL. The HFS-II subscale contains 18 items that measure the degree of worry about hypoglycemia in the last 6 months (from 0=none to 3=almost always). Their total score can range between 0 and 72 points (higher scores indicate increased fear). Both questionnaires are translations validated by the MAPI Institute14 and are certified by the authors. The ADDQoL questionnaire has been employed in Spain15,16 but has not been used with patients with DM2 with or without hypoglycemia. The HSF-II subscale has not been previously used for the Spanish population; we therefore proceeded to validate the subscale in another phase of this study.17

Four questions were designed for the purposes of this study to explore the knowledge and attitudes of physicians concerning patients’ HRQL and worry about hypoglycemia: (1) “Do you use questionnaires to measure the HRQL of your patients with DM2?”; (2) “To what extent do you believe you know the risk of hypoglycemia associated with treatments for DM2?”; (3) “How often would you say you explore the degree of worry that hypoglycemia causes in your patients?”; and (4) “How often would you say that hypoglycemia requires you to modify the indicated therapeutic regimen?” The physicians answered each of the 4 questions using a visual analog scale of 10cm, with 0 indicating none/never and 10 indicating the maximum/as often as possible.

Determining the number of participants

We proposed to detect a difference between the scores given by the patients who reported hypoglycemic episodes and those who reported none, in terms of the ADDQoL questionnaire and the HFS-II worry subscale, the main outcome variables. After a review of previous studies that used the same instruments, we selected the mean of the scores assigned to the 19 specific items of the ADDQoL18 as a reference for the calculation. Based on the difference between the study groups and assuming a standard deviation (SD) of 0.5, we calculated an effect size of 0.12. Based on this figure and applying a 95% statistical power and an alpha error of 0.05, we determined that a total of 3784 patients were needed. Assuming a 5% loss, the sample size was calculated at 3973 patients.

Statistical analysis

A descriptive analysis was performed on the sample, which determined the mean, SD, median, minimum, maximum, percentiles (for quantitative variables) and frequency and 95% confidence intervals (CI) (for qualitative variables). We compared the characteristics of the patients who experienced hypoglycemia in the last 6 months with those of the other patients, using the t-test for continuous variables and the chi-squared test for the categorical variables. We calculated the 95% CI for the mean difference of the ADDQoL and HFS-II subscale scores between the 2 populations. Finally, we performed a correlation analysis (Pearson's correlation test) and a test for independence between the mean scores for the 19 specific items of the ADDQoL questionnaire and the overall scores on the HFS-II subscale. The SPSS v.18 statistical program was used for the calculations.

ResultsPatient population characteristics

The study included 4054 patients, 242 (6%) of whom were excluded for not meeting the selection criteria (231 patients with a DM2 diagnosis less than 1 year ago, 8 individuals younger than 18 years, 1 patient requiring translation of the tools and 2 participants who failed to meet several of these criteria). Of the 3812 patients included in the analysis, 54% were men, with a mean age of 64 years±11 years and a mean time from diagnosis of 10 years±7 years. Table 1 lists the demographic and clinical characteristics of the population based on the presence (45%) or not (55%) of hypoglycemia during the previous 6 months. The patients who reported hypoglycemic episodes had longer times from disease diagnosis and lower body mass index. The number of participants with a known family history of DM2 and the presence of microvascular and macrovascular complications was higher. For these patients, the mean number of hypoglycemic episodes in the last 6 months was 5±11 years. The morning was the most common time of day for the episodes (41%) and was when they were most severe (43%). For 14% of these patients, the hypoglycemic episodes caused work absences. Eleven percent and 26% of the patients with hypoglycemia required a mean of 1.63±1.34 and 1.86±1.32 hospitalizations and emergency department visits in the last 6 months, respectively.

Table 1.

Sociodemographic and clinical characteristics of the patients with type 2 diabetes mellitus who reported or did not report hypoglycemia in the last 6 months.

Population characteristics  Total population (n=3812)  Patients with hypoglycemia (n=1711)  Patients without hypoglycemia (n=2100)  p-value 
Men, % (95% CI)  54 (52–55)  52 (49–54)  55 (53–57)  .0558 
Mean age±SD, years  64±11  63±12  64±11  .0426 
Mean time from diagnosis±SD, years  10±11±9±<.0001 
Mean weight±SD, kg  78.9±14  78.1±13.8  79.6±14.1  .0012 
Mean BMI±SD, kg/m2  29.0±4.7  28.6±4.6  29.3±4.8  <.0001 
Pensioners, % (95% CI)  43 (41–45)  42 (39–44)  44 (42–46)  .1547 
Dieting, % (95% CI)  79 (78–81)  80 (78–82)  79 (77–81)  .5951 
Low frequency of physical activitya (95% CI), %  53 (52–55)  53 (51–56)  53 (51–55)  .0523 
Smokers (95% CI), %  15 (14–17)  16 (14–18)  15 (14–17)  .2625 
Alcohol consumersb (95% CI), %  40 (39–42)  39 (36–41)  42 (40–44)  .06 
Family history of DM2 (95% CI), %  58 (56–59)  62 (60–65)  54 (52–56)  <.0001 
Microvascular and macrovascular complications (95% CI), %  63 (62–65)  71 (69–73)  57 (55–59)  <.0001 
Macrovascular complications, % (95% CI)  40 (38–42)  44 (41–47)  36 (34–39)  .0002 
Microvascular complications (95% CI), %  50 (58–42)  60 (57–62)  41 (38–43)  <.0001 
a

Walks less than half an hour a day/5 days a week.

b

Patients with low alcohol consumption (<40g/day for men; <24g/day for women), moderate (40–59g/day for men; 24–39g/day for women) and high (>60g/day for men; >40g/day for women).

Health-related quality of life

The mean scores assigned by the patients to the general items of the ADDQoL (Table 2) were between “neither good nor bad” (0 points) and “good” (1 point), both for participants who experienced hypoglycemia and those that did not (0.37±0.98 vs. 0.40±0.98; p=.28). Their assessment of their quality of life had they not had diabetes was located between “a little better” (−1 point) and “much better” (−2 points), indicating a negative impact of diabetes on their overall quality of life, showing no significant differences between the 2 groups (−1.41±0.87 vs. −1.36±0.85; p=.11). The mean scores for each of the 19 specific items were lower for the patients who experienced hypoglycemia (p<.001 in all cases), with the “freedom to eat” and “freedom to drink” items having a more negative impact. The overall impact of diabetes on the quality of life (mean score on the 19 items) was greater among those patients who had experienced hypoglycemia (−2.48±1.61) than on the others (−1.64±1.36) (p<.001).

Table 2.

Quality of Life (ADDQoL questionnaire) of patients with type 2 diabetes mellitus who reported or who did not report hypoglycemic episodes in the last 6 months.

ADDQoL Item  Mean score±SDMean difference (95% CI) 
  Total population (n=3812)  Patients with hypoglycemia (n=1711)  Patients without hypoglycemia (n=2100)   
General
I. In general, your quality of life is currentlya  0.39±0.98  0.37±0.98  0.40±0.98  −0.03 (−0.09; 0.03) 
II. If you did not have diabetes, your quality of life would beb  −1.38±0.86  −1.41±0.87  −1.36±0.85  −0.05 (−0.10; 0.00) 
Specificc
1. Leisure time activities  −2.25±2.24  −2.78±2.35  −1.81±2.03  −0.97 (−1.11; −0.83) 
2. Work life  −2.53±2.41  −3.11±2.51  −2.04±2.21  −1.07 (−1.31; −0.83) 
3. Going on trips  −1.89±2.18  −2.39±2.26  −1.47±2.02  −0.92 (−1.06; −0.78) 
4. Vacations  −2.52±2.39  −3.10±2.49  −2.06±2.19  −1.04 (−1.21; −0.87) 
5. Physical condition  −2.22±2.26  −2.80±2.40  −1.74±2.01  −1.06 (−1.20; −0.92) 
6. Family  −2.03±2.35  −2.50±2.47  −1.65±2.19  −0.85 (−1.00; −0.70) 
7. Social life  −1.62±2.18  −2.07±2.35  −1.26±1.95  −0.81 (−0.95; −0.67) 
8. Emotional life  −2.05±2.52  −2.52±2.71  −1.68±2.29  −0.84 (−1.02; −0.66) 
9. Sex life  −2.70±2.78  −3.15±2.91  −2.36±2.63  −0.79 (−1.00; −0.58) 
10. Physical appearance  −1.47±1.99  −1.82±2.16  −1.19±1.80  −0.63 (−0.76; −0.50) 
11. Self-confidence  −1.83±2.34  −2.43±2.56  −1.35±2.01  −1.08 (−1.23; −0.93) 
12. Motivation  −1.55±2.07  −2.04±2.24  −1.15±1.82  −0.89 (−1.02; −0.76) 
13. Reactions of other people  −0.67±1.53  −0.87±1.73  −0.49±1.32  −0.38 (−0.48; −0.28) 
14. Feelings about the future  −2.29±2.39  −2.77±2.53  −1.79±2.18  −0.98 (−1.13; −0.83) 
15. Financial situation  −0.74±1.67  −1.02±1.94  −0.52±1.37  −0.50 (−0.61; −0.39) 
16. Housing situation  −0.65±1.52  −0.83±1.73  −0.49±1.31  −0.34 (−0.44; −0.24) 
17. Dependency  −2.19±2.51  −3.03±2.66  −1.51±2.15  −1.52 (−1.67; −1.37) 
18. Freedom to eat  −4.39±2.82  −4.86±2.76  −3.99±2.82  −0.87 (−1.05; −0.69) 
19. Freedom to drink  −3.57±2.88  −3.94±2.91  −3.26±2.83  −0.68 (−0.86; −0.50) 
Overall
Mean impact (mean of 19 items)  −2.01±1.54  −2.48±1.61  −1.64±1.36  −0.84 (−0.93; −0.75) 
a

3=excellent; 2=very good; 1=good; 0=neither good nor bad; −1=bad; −2=very bad; −3=terrible; p=.28.

b

−3=much better; −2=better; −1=a little better; 0=the same; 1=worse; p=.11.

c

−9=maximum negative impact to 3=maximum positive impact; p<.001 for the 19 items.

Fear of hypoglycemia

By comparing the distribution of the scores assigned by the patients in the subscale HFS-II according to whether they reported hypoglycemic episodes or not, we found statistically significant differences (p<.001) between the 2 groups in the 18 items of the subscale. Thus, the patients with hypoglycemia indicated a greater frequency of fear for the issues measured by each item, compared with the patients who did not experience hypoglycemia. Additionally, the mean score on the HFS-II subscale for the patients with hypoglycemia (31.32±15.71) was greater than that achieved by the others (18.85±16.03) (p<.0001; SD, 12.47; 95% CI 11.42–13.52), indicating a greater degree of worry about hypoglycemia in the first group.

Finally, the results showed a correlation between the mean scores on the ADDQoL questionnaire and the HFS-II subscale (correlation value, −0.441), indicating that as the worry grew, the lower the patients’ perceived HRQL (p<.001 in the test for independence).

Attitudes and knowledge of the medical professionals

On a scale from 0 to 10, the scores attributed by the physicians reveal that they do not usually employ questionnaires to measure their patients’ HRQL (mean, 2.83±2.74 points; median, 1.91), even though they state that they understand the risk of hypoglycemia associated with DM2 treatments (mean, 7.80±1.75 points; median, 8). The doctors discreetly explore the worry that hypoglycemia creates in their patients (mean, 5.92±2.52 points; median, 6.26) and occasionally changed the patient's indicated therapeutic regimen due to the presence of hypoglycemia (mean, 5.64±2.78 points; median, 5.74).

Discussion

The results of this study show the negative influence of DM2, of hypoglycemic episodes and the worry they exert on HRQL in an extensive sample of patients with DM2 from 17 autonomous communities in Spain.23

Almost half of the participants reported hypoglycemic episodes during the last 6 months. Although the type of treatment they received was not recorded, the finding is consistent with that indicated by other studies performed both with patients undergoing oral treatments (metformin, sulfonylureas and glitazones)7,8,19,20 and those undergoing insulin treatment9,21 who self-reported the hypoglycemia episodes.

In line with the results of other studies,16,17,22 the patients showed a negative impact of DM2 on the 19 domains of the ADDQoL questionnaire, with “freedom to eat” and “freedom to drink” the issues that reflected the most unfavorable impact, showing that diet restriction is one of the factors that is perceived the worst by patients.11 This study also shows how the presence of hypoglycemia creates a still greater impact on each of the measures of the ADDQoL. A similar result was obtained in the PANORAMA study,22 in which it was apparent that the factors that negatively affect HRQL (in addition to the previous hypoglycemic episodes) are poor metabolic control and more complex treatments, factors that in turn create greater worry of presenting hypoglycemia. Although our study observed no significant differences in the general items of the ADDQoL between the 2 groups, this could be explained by the fact that these items can be expected to reflect a similar behavior to that of a generic HRQL questionnaire, that is, one that is less sensitive than a more specific one. It should be taken into account that the measure that evaluates the mean impact of DM2 on the patients’ HRQL is the mean scores assigned to the 19 specific domains of the ADDQoL questionnaire and not the general items. Other authors who have assessed the HRQL of patients with DM2 with other questionnaires have encountered a deterioration in all areas, especially in “anxiety/depression”, “daily activities”, “mobility” and “pain/discomfort”, in terms of the presence of hypoglycemia6 and/or their worry about those things.7,8,20 The authors have also observed a decrease in the value of preference (usefulness) by this health condition,19 showing the impact that hypoglycemia has on the HRQL of patients with DM2.

The degree of worry about hypoglycemia was greater among the patients who reported episodes than among those who reported none. These results agree with those obtained by other authors who used the same worry subscale and similar observation periods.7,8,19,20 Although the mean score on the HFS-II subscale calculated in this study was greater, this could be explained by the presence of socio-cultural differences between the populations.

Another relevant aspect of this study is that the doctors’ results show that these professionals do not usually employ questionnaires to measure their patients’ HRQL. They know the risk of hypoglycemia associated with certain treatments, and its onset makes them change the prescribed regimen, but they only occasionally explore the worry that these episodes create. We believe that these results are transcendent, considering that hypoglycemic episodes and the worry they cause can lead to the patient developing self-regulation attitudes toward medication and low adherence to it to avoid this treatment complication.24

A significant limitation of this study is the lack of data on the type of drug treatment and the HbA1c levels of the population. This type of information would probably have allowed us to define all the factors that could influence the perception of HRQL. The study's cross-sectional design limits the possibility of establishing changes over time in the relationship between the perception of HRQL and the worry about hypoglycemia, as well as the factors that explain them. These current limitations should serve to direct the design and objectives of future studies.

In conclusion, DM2 negatively influences patients’ HRQL, especially when they have hypoglycemia. The presence of hypoglycemic episodes creates increased fear about these episodes and worsens the perception of HRQL. Incorporating the examination of these aspects by medical professionals in standard clinical practice could promote a therapeutic approach directed toward the patients’ needs, contributing to a better perception of HRQL.

Funding

This study funded by Novartis Pharmaceuticals S.A., who did not interfere with the final results.

Conflicts of interest

The authors declare that they have no conflicts of interests.

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Please cite this article as: Jódar-Gimeno E, Álvarez-Guisasola F, Ávila-Lachica L, Palomares-Ortega R, Roldán-Suárez C, Lizán-Tudela L. Calidad de vida y grado de preocupación por las hipoglucemias en pacientes con diabetes mellitus tipo 2. Rev Clin Esp. 2015;215:91–97.

Corresponding author. (E. Jódar-Gimeno ejodar.mad@quiron.es)
Copyright © 2014. Elsevier España, S.L.U.