Quality of life in type 2 diabetes patients under intensive multitherapy

doi:10.1016/j.diabet.2006.09.001

Diabetes & Metabolism

Volume 33, Issue 1, February 2007, Pages 54-60

https://doi.org/10.1016/j.diabet.2006.09.001 Get rights and content

Abstract

Aim

To assess the impact of an intensive multitherapy (IMT) on perceived quality of life (QOL), attitudes, knowledge and diabetes self-management in patients with poorly controlled type 2 diabetes.

Methods

A 12-month randomized trial was conducted in 72 patients with type 2 diabetes, HbA_1c ≥ 8%, blood pressure (BP) > 130/80 mmHg and dyslipidemia. Subjects were assigned to the IMT or control group, each n = 36. IMT consisted in monthly visits including clinical and biochemical assessment, education sessions on diet, physical exercise, medical management of diabetes and associated diseases and adjustments in medication. Control patients were under the care of their physicians. We developed and validated a diabetes-specific questionnaire assessing QOL, attitudes, knowledge, diabetes self-management and socio-demographic data for this study. Outcomes were measured at 0, 6 and 12 months.

Results

Subjects were 54.8 ± 8.1 years old (duration of diabetes: 10.3 ± 7.2 years). At baseline, questionnaires showed no difference in QOL between groups. At 12 months, QOL improved significantly in the IMT group when compared to controls (+13.2 ± 10.3/+5.6 ± 13.2%, P = 0.003), particularly with respect to the satisfaction scale (+25.3 ± 13.9/+5.4 ± 21.7%, P < 0.001). QOL was not affected by complications or hypoglycaemic episodes. QOL scores improved in IMT subjects who began insulin therapy during the trial. Attitude scores, in the high normal range at baseline, did not change. Knowledge (+18.2 ± 26.3/+8.9 ± 30.4%, P = 0.047) and diabetes self-management (+22.6 ± 35.3/+6.8 ± 20.1%, P < 0.001) improved.

Conclusions

In poorly controlled subjects, QOL improved statistically despite the inherent constraints imposed by IMT.

Résumé

Qualité de vie des diabétiques de type 2 sous traitement intensif multifactoriel.

Objectif

Évaluer, chez des patients diabétiques (type 2) mal contrôlés, l'impact d'un traitement intensif multifactoriel sur la qualité de vie, les attitudes, les connaissances et la prise en charge du traitement.

Méthodes

Une étude randomisée de 12 mois a été effectuée chez 72 sujets diabétiques de type 2 (HbA_1c ≥ 8 %, pression artérielle > 130/80 mmHg et dyslipidémie). Un questionnaire spécifique a été développé et validé pour analyser (à 0, 6 et 12 mois) les quatre sphères citées ci-dessus ainsi que les variables sociodémographiques des participants. Les 36 sujets du groupe traitement intensif multifactoriel devaient suivre un régime et un programme d'exercices physiques ; ils étaient vus tous les mois (prises de sang, éducation portant sur le régime, l'exercice physique, la gestion du diabète et des maladies associées, ajustements et/ou augmentation de médications). Les patients du groupe témoin bénéficiaient du suivi habituel, avec bilan biologique à 0, 6 et 12 mois.

Résultats

Au début de l'étude, les patients étaient âgés de 54,8 ± 8,1 ans (durée du diabète : 10,3 ± 7,2 ans) et il n'y avait aucune différence entre les groupes. À 12 mois, la qualité de vie s'est améliorée dans le groupe traitement intensif multifactoriel comparativement au groupe témoin (+13,2 ± 10,3/+5,6 ± 13,2 %, p = 0,003), en particulier pour l'échelle de satisfaction (+25,3 ± 13,9/+5,4 ± 21,7 %, p < 0,001). Ces résultats ont été retrouvés chez les participants qui ont débuté l'insuline durant l'étude. La qualité de vie n'a pas été affectée par les complications ni les hypoglycémies. Le score des attitudes, élevé au début de l'étude, est resté stable. Les connaissances (+18,2 ± 26,3/+8,9 ± 30,4 %, p = 0,047) et la prise en charge du traitement (+22,6 ± 35,3/+6,8 ± 20,1 %, p < 0,001) ont progressé.

Conclusion

Chez les diabétiques de type 2 mal contrôlés, le traitement intensif multifactoriel améliore la qualité de vie malgré les contraintes inhérentes au traitement.

Introduction

Glycaemic control [1] as well as reducing blood pressure (BP) [2] and lipoprotein concentrations [3] are three major therapeutic objectives for prevention of target organ damage and other complications arising from diabetes. Studies have shown that a comprehensive and aggressive management approach is effective in decreasing the rate of progression of cardiovascular complications [1], [4]. Intensive multitherapy (IMT), requiring substantial patient self-participation, is often necessary and therefore currently recommended [5], [6]. Accordingly, patients must deal with diabetes and associated diseases, making countless decisions in an effort to approximate the non-diabetic metabolic state on a day-to-day basis [7]. Importantly, the heavy psychosocial burden of living with diabetes can affect self-care behavior and quality of life (QOL) [8], [9] as well as the long-term risk of developing complications. Surprisingly, the perceived impact of a rigorous IMT on QOL has never been thoroughly explored in patients with poorly controlled type 2 diabetes.

We hypothesized that in patients with poorly controlled type 2 diabetes, a 12-month IMT program could improve QOL despite the constraints of the intervention. To address this question in a French-speaking population, a 5-section diabetes-specific questionnaire assessing QOL, attitudes, knowledge, diabetes self-management and socio-demographic data was developed and validated. The trial was conducted in subjects presenting without stringent complications, although at very high risk for microvascular and macrovascular events, [3], [10], [11] in order to assess the effects and feasibility of an IMT program in a subset of the vast population of patients with poorly controlled type 2 diabetes commonly treated by family practitioners and endocrinologists.

Section snippets

General design of the study

The design of this 12-month randomized controlled trial was reported in detail previously [12]. Briefly, sedentary patients aged 30-70 yrs with poorly controlled type 2 diabetes (HbA_1c ≥ 8%), high BP and dyslipidemia were randomized to the IMT group or the control group (conventional treatment by physician). Therapeutic goals were HbA_1c < 7%, BP < 130/80 mmHg, LDL-C < 2.5 mmol/l, ratio cholesterol/HDL < 4.0 and triglycerides < 1.5 mmol/l [5].

The components of intensive multitherapy were:

1)
monthly visits

At baseline

There was no significant difference between groups (each n = 36) with respect to age, gender, duration of diabetes, lifestyle habits and arrangements, education or occupation (Table 1). Prevalence of minor complications [12] was equally distributed in both groups. QOL, attitude, knowledge and self-management scores did not differ between IMT and control groups (Table 2). As reported elsewhere [12], only 3 subjects (2 in the intervention group and 1 in the control group) were lost to follow-up

Discussion

This prospective study showed that quality of life improved significantly in subjects with poorly controlled type 2 diabetes receiving intensive multitherapy, despite the constraints of such an intervention on sedentary subjects.

Our results differ from others' reporting that intensive therapies had no or little detrimental effect on QOL [9], [17]. The clinical significance of our statistical data could be debated; lack of strong published data precludes a clear interpretation in this regard.

Acknowledgements

This work was supported by the Clinical Research Center of the Centre Hospitalier Universitaire de Sherbrooke and by grants from the Quebec Diabetes Association (Thetford Mines) and Brystol-Myers Squibb. We thank Lise Trottier, M.Sc., for her assistance in the statistical analyses, and Pierre Pothier and Monique Sullivan for their critical reading and editorial assistance.

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Self-Monitoring of Blood Glucose: A Complementary Method Beyond the Oral Glucose Tolerance Test to Identify Hyperglycemia During Pregnancy
2019, Canadian Journal of Diabetes
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SMBG values were classified as being either below or above recommended targets and, per protocol, were used to define pregnancy hyperglycemia. Based on the Metformin in Gestational Diabetes study (3) and on the Diabetes Treatment Satisfaction Questionnaire (28), a 5-item suitability questionnaire was developed using standard back-translation, English/French, as we had done in another study (29). Data concerning pregnancy, delivery and neonatal outcomes were extracted from medical files.
To compare: 1) 75 g oral glucose tolerance test (OGTT) and self-monitoring of blood glucose (SMBG) in identifying gestational diabetes mellitus (GDM) and other hyperglycemic statuses in pregnant women; 2) pregnancy outcomes according to glycemic status; and 3) participants’ opinions regarding both methods.
A prospective study in women with a 50 g glucose load test ≥7.2 mmol/L at 24 to 28 weeks’ gestation and singleton pregnancy. Women underwent OGTT (blinded) at day 1, followed by 7 days of SMBG (4 daily measurements: fasting and 2 h postprandially) without modifying diet or lifestyle. GDM (OGTT+) was diagnosed using the criteria of the International Association of the Diabetes and Pregnancy Study Groups, while pregnancy hyperglycemia (SMBG+) was defined as ≥4/7 glucose values ≥5.3 after fasting or ≥6.7 mmol/L 2 h postprandially for any meal of the day. Equivalent management was provided to women with GDM and/or pregnancy-related hyperglycemia.
We divided 103 participants (age: 29.5±5.0 years; prepregnancy body mass index: 25.3±5.4 kg/m²) into 4 groups according to test results: OGTT+/SMBG+ (n=12, 11.7%); OGTT+/SMBG– (n=14, 13.6%); OGTT–/SMBG+ (n=9, 8.7%); and OGTT–/SMBG– (n=68, 66.0%). Clinical characteristics and maternal outcomes were statistically similar between groups. Neonatal complication rates were greater in groups with hyperglycemia than in the OGTT–/SMBG– group, notably neonatal hypoglycemia (9/12, 7/14, 5/9 vs. 6/68; p<0.001). Participants reported no convenience difference between methods but would prefer OGTT for a future pregnancy.
More than half of the women with OGTT+ were normoglycemic in daily life. Conversely, 11.7% of women with OGTT– had pregnancy hyperglycemia. OGTT+ and/or SMBG+ were equally associated with greater neonatal complications. This study suggests that alongside OGTT, SMBG could improve the care of pregnant women.
Comparer: 1) le test d’hyperglycémie provoquée par voie orale (HGPO) avec 75 g de glucose et une autosurveillance de la glycémie (ASG) dans l'identification du diabète gestationnel (DG) et d'autres états hyperglycémiques chez la femme enceinte; 2) les issues de grossesse en fonction de l'état glycémique; et 3) l’opinion des participantes concernant les deux méthodes.
Une étude prospective chez des femmes présentant une épreuve de charge en glucose de 50 g ≥ 7,2 mmol/L entre 24 et 28 semaines de gestation et une grossesse unique. Les femmes ont subi une HGPO (résultats en aveugle) au jour 1, suivie de 7 jours d’ASG (4 mesures quotidiennes: à jeun et 2 h après les repas) sans modifier leur régime alimentaire ni leur mode de vie. Le DG (HGPO+) a été diagnostiqué selon les critères de l’Association Internationale des Groupes d’Etude sur le Diabète et la Grossesse, tandis que l’hyperglycémie de grossesse (ASG+) était définie par ≥4/7 valeurs de glucose ≥5,3 à jeun ou ≥ 6,7 mmol/L 2 h après les repas pour tout repas de la journée. Une prise en charge équivalente a été fournie aux femmes atteintes de DG et/ou d'hyperglycémie liée à la grossesse.
Nous avons réparti 103 participantes (âge: 29,5±5,0 ans; indice de masse corporelle avant la grossesse: 25,3±5,4 kg/m²) en 4 groupes selon les résultats des tests: HGPO+/ASG+ (n=12, 11,7%); HGPO+/ASG– (n=14, 13,6%); HGPO–/ASG+ (n=9, 8,7%); et HGPO–/ASG– (n=68, 66,0%). Les caractéristiques cliniques et les issues maternelles étaient statistiquement similaires entre les groupes. Les taux de complications néonatales étaient plus élevés dans les groupes avec hyperglycémie que dans le groupe HGPO–/ASG–, notamment l'hypoglycémie néonatale (9/12, 7/14, 5/9 contre 6/68, p<0,001). Les participantes n'ont signalé aucune différence de commodité entre les méthodes, mais préféreraient l’HGPO pour une future grossesse.
Plus de la moitié des femmes avec HGPO+ étaient normoglycémiques dans la vie quotidienne. À l’inverse, 11,7% des femmes avec HGPO– présentaient une hyperglycémie de grossesse. L’HGPO+ et/ou l’ASG+ étaient également associées à de plus grandes complications néonatales. Cette étude suggère que, parallèlement à l’HGPO, l’ASG pourrait améliorer les soins prodigués aux femmes enceintes.
Correlates of health-related quality of life in French people with type 2 diabetes
2013, Diabetes Research and Clinical Practice
Diabetes is known to impair health-related quality of life (HrQol). Our aim was to analyse a comprehensive set of potential determinants of HrQol in a large sample of patients with diabetes.
This study is based on the ENTRED 2007 study, a representative sample of adults (18 years and older) with diabetes. Data were extracted from postal self-reported questionnaires (from patients and medical practitioners) and from reimbursements from the National health insurance data system. HrQol was assessed with the MOS SF-12 for mental (MCS) and physical (PCS) component summaries. Multivariate linear regression models were used to analyse the variables associated with HrQol.
SF-12 MCS and PCS were available in 2832 patients with T2DM, with a mean age 64 years (1715 males, 56%). Lower income, severe hypoglycaemic episodes, hospitalisation ≥24 h, instrumental daily living (IADL) restriction, low satisfaction for social support and an HbA1c within the 8.1–10.0% range were associated with lower MCS rating, whereas an older age and male gender were associated with higher MCS. Older age, female sex, higher BMI, lower income, insulin treatment, macrovascular complications, severe hypoglycaemic episodes, hospitalisation ≥24 h, and IADL restriction were associated with lower PCS values whereas having no need for social support was associated with higher PCS values.
HrQol associated factors are multiple but mainly linked with socio-demographic factors, diabetes complications and satisfaction for social support. A patient centred approach should be tested to prevent impairment of HrQol and thus to decrease the burden of diabetes. Assessment of social support should be included.
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To assess in standard clinical practice the feasibility, efficacy, and safety of switching patients with long-standing type 2 diabetes (T2DM) and poor or unstable blood glucose control to basal-bolus insulin therapy.
This was a prospective, single center study including 37 patients with T2DM (age 65 ± 8 years, 62.2% men, body mass index 28.8 ± 6.2 kg/m², diabetes duration 18 ± 8 years) with poor or unstable glycemic control, who were switched to a basal-bolus insulin regimen with glargine and rapid-acting insulin analogue at the discretion of their physicians. After a group-structured outpatient diabetes training program, patients were followed in a clinical practice setting for 6 months. Clinical and biochemical variables were collected before switching and at 3 and 6 months.
After switching to basal-bolus therapy, glycosylated hemoglobin (HbA1c) decreased from 9 ± 1.2% to 8.1 ± 1.2% (p < 0.001) at 3 months and to 8.0 ± 1.2% at 6 months (p < 0.001) without changing total daily insulin dose. The proportion of patients with HbA1c ≥ 9% decreased from 51% to 13.8% at 3 months and to 18.9% at 6 months respectively. There was a single episode of severe hypoglycemia. No changes were seen in body weight and quality of life. The size of LDL (low density lipoprotein) particles significantly increased at 3 and 6 months, while all other lipid parameters remained unchanged.
Our study confirmed that basal-bolus insulin therapy is feasible, effective, and safe in patients with long-standing T2DM, and does not impair their quality of life.
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Estudio prospectivo de 37 sujetos con DM2 (edad 65 ± 8 años, 62,2% varones, índice de masa corporal 28,8 ± 6,2 kg/m², tiempo de evolución de la diabetes 18 ± 8 años) en los que se transfirió a una pauta bolus-basal (una dosis de glargina y 3 de aspártica o lispro) según el criterio de su médico. El tratamiento se instauró en un programa ambulatorio y el seguimiento se realizó durante 6 meses. Los parámetros clínicos y analíticos se recogieron a los 0, 3 y 6 meses.
Tras el cambio a la pauta bolus-basal, la hemoglobina glucosilada (HbA1c) se redujo de 9 ± 1,2% al inicio a 8,1 ± 1,2% (p < 0,001) a los 3 meses y a 8,0 ± 1,2% a los 6 meses (p < 0,001) sin modificarse la dosis diaria total de insulina. El porcentaje de pacientes con HbA1c ≥ 9% cayó del 51% inicial al 13,8% a los 3 meses y al 18,9% a los 6 meses, respectivamente. Se registró una hipoglucemia grave. El peso y la calidad de vida no mostraron cambios. El tamaño de las partículas de LDL (lipoproteínas de baja densidad) aumentó significativamente a los 3 y 6 meses, mientras que otros parámetros lipídicos no se modificaron.
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WHO-5, a tool focusing on psychological needs in patients with diabetes: The French contribution to the DAWN study
2012, Diabetes and Metabolism
Citation Excerpt :
The second objective was to compare the scores of patients with diabetes with those of patients with other CDs in a French sample population. The WHO-5 is also used by HCPs to identify patients who require further evaluation for possible depression or related problems, and has been applied in many clinical contexts, especially in diabetes [10–15], the impact of which on well-being and quality of life has been extensively studied. The demands posed on diabetes patients on a daily basis as regards self-management of treatment and changes in lifestyle can be a burden, resulting in a negative view of the disease and/or its management [16–18].
In 2001, the international Diabetes Attitudes, Wishes and Needs (DAWN) programme was launched to evaluate the psychosocial impact of diabetes. In France, DAWN experts carried out an observational study to further understand the impact of diabetes on the psychological well-being of people with diabetes, using the French version of the WHO-5 questionnaire.
The WHO-5, a unidimensional five-item questionnaire that measures positive psychological well-being, was completed by 2213 patients (1670 with diabetes). A total sum score was calculated, ranging on a scale from 0 to 25. A score less than 13 indicated impaired well-being and a score less than 8 reflected likely depression.
The mean total well-being score for the whole study population was 14.1 ± 5.5, and 14.3 ± 5.5 for patients with diabetes and 13.5 ± 5.4 for patients with other chronic diseases. The average score for patients with diabetes only (15.1 ± 5.2) was higher than those for the other subgroups (P = 0.005), whereas the average scores for those using insulin (14.8 ± 5.2) and women with diabetes (13.2 ± 5.6) were significantly lower compared with the whole diabetic group (15.6 ± 5.1 [P = 0.03] and 15 ± 5.2 [P < 0.001], respectively).
The WHO-5 questionnaire showed satisfactory psychometric properties in a large sample of French diabetic patients. The scale is unidimensional and highlighted differences in well-being, which was lower in diabetic women, in patients with other chronic diseases and in those treated with insulin.
À partir de 2001, le programme international Diabetes Attitudes, Wishes and Needs (DAWN) s’est donné pour mission d’évaluer l’impact psychosocial du diabète. Le groupe DAWN France a ainsi mis en place une enquête destinée à évaluer l’impact du diabète sur le bien-être des patients diabétiques en utilisant la version française du questionnaire WHO-5 (OMS).
Le questionnaire WHO-5 a été rempli par 2213 patients dont 1670 étaient diabétiques. Ce questionnaire est unidimensionnel et composé de cinq items qui mesurent le bien-être psychologique avec une note globale comprise entre 0 et 25. Un score inférieur à 13 indique un bien-être altéré, un score inférieur à 8 une probable dépression.
Le score moyen de bien-être dans l’ensemble de la population étudiée était de 14,1 ± 5,5 points. Il était de 14,3 ± 5,5 en considérant l’ensemble des patients atteints de diabète, et de 13,5 ± 5,4 pour les patients ayant une autre maladie chronique. Le score moyen des patients ayant un diabète seul était plus élevé (15,1 ± 5,2) que celui des autres sous-groupes (P = 0,005). Les diabétiques recevant de l’insuline (14,8 ± 5,2 versus 15,6 ± 5,1 [P = 0,03] et les femmes diabétiques 13,2 ± 5,6 versus 15 ± 5,2 [P < 0,001]) avaient des scores significativement plus faibles que la moyenne de l’ensemble des patients diabétiques.
Appliqué à une large population de patients diabétiques français le questionnaire WHO-5 a démontré des capacités d’évaluation psychométrique satisfaisantes. L’échelle est unidimensionnelle et met en évidence des différences de bien-être entre différentes typologies de sujets diabétiques. Il est plus bas chez les femmes, les patients ayant d’autres maladies chroniques associées et chez ceux traités par insuline.
Patients' education, and its impact on care outcomes, resource consumption and working conditions: Data from the International Diabetes Management Practices Study (IDMPS)
2012, Diabetes and Metabolism
To evaluate the impact of diabetes education provided to patients with type 2 diabetes mellitus (T2DM) in non-controlled studies (“real-world conditions”) on quality of care, resource consumption and conditions of employment.
This cross-sectional study and longitudinal follow-up describe the data (demographic and socioeconomic profiles, clinical characteristics, treatment of hyperglycaemia and associated cardiovascular risk factors, resource consumption) collected during the second phase (2006) of the International Diabetes Management Practices Study (IDMPS). Patients received diabetes education directly from the practice nurse, dietitian or educator, or were referred to ad hoc group-education programmes; all programmes emphasized healthy lifestyle changes, self-care and active participation in disease control and treatment. Educated vs non-educated T2DM patients (n = 5692 in each group), paired by age, gender and diabetes duration, were randomly recruited for the IDMPS by participating primary-care physicians from 27 countries in Eastern Europe, Asia, Latin America and Africa. Outcome measures included clinical (body weight, height, waist circumference, blood pressure, foot evaluation), metabolic (HbA_1c levels, blood lipid profile) and biochemical control measures. Treatment goals were defined according to American Diabetes Association guidelines.
T2DM patients’ education significantly improved the percentage of patients achieving target values set by international guidelines. Educated patients increased their insulin use and self-care performance, had a lower rate of chronic complications and a modest increase in cost of care, and probably higher salaries and slightly better productivity.
Diabetes education is an efficient tool for improving care outcomes without having a major impact on healthcare costs.
Évaluer l’impact de l’éducation prodiguée aux patients atteints de diabète de type 2 à partir de l’étude observationnelle (dans les conditions réelles de suivi des patients) de la qualité des soins et de leurs coûts, exprimés en dépenses de soins et en journées de travail perdues.
Étude transversale et longitudinale ayant pour but de recueillir des données des patients concernant leur profil socioéconomique, le traitement du diabète et de ses complications et les coûts. Cette étude appartient à la seconde vague de l’International Diabetes Management Practices Study (IDMPS) (2006). Les patients ont reçu des informations relatives au diabète d’une infirmière, d’un diététicien, d’un éducateur spécialisé ou grâce à un programme d’éducation spécifique. Chaque programme mettait l’accent sur les modifications hygiéno-diététiques et la prise en charge active de la maladie et de son traitement par le patient lui-même. Les diabétiques de type 2 qui avaient reçu on non cette éducation (n = 592 dans chaque groupe) étaient appariés selon l’âge, le sexe, et la durée de diabète. Les patients avaient été recrutés par randomisation par les médecins traitants de 27 pays de l’Europe de l’Est, de l’Asie, de l’Amérique Latine et d’Afrique. Les données recueillies étaient cliniques (poids, taille, périmètre adominal, pression artérielle, examen des pieds), métabolique (HbA_1c, profil lipidique) et biologiques. Les objectifs de traitement étaient ceux définis par les recommendations de l’American Diabetes Association.
L’éducation diabétique apportée aux diabétiques de type 2 augmente significativement le pourcentage de patients atteignant les objectifs de traitement définis par les recommandations internationales. Les patients qui avaient reçu une éducation diabétologique utilisaient davantage l’insuline et se prenaient mieux en charge. Ils présentaient un plus faible pourcentage de complications chroniques. Une augmentation modérée des coûts de traitement fut notée, associée probablement à des salaires plus élevés et à une productivité légèrement plus élevée.
L’éducation diabétique est efficace et améliore le devenir des patients sans élévation importante des coûts de traitement.

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Original articleQuality of life in type 2 diabetes patients under intensive multitherapy

Abstract

Aim

Methods

Results

Conclusions

Résumé

Objectif

Méthodes

Résultats

Conclusion

Introduction

Section snippets

General design of the study

At baseline

Discussion

Acknowledgements

J. Clin. Epidemiol.

Soc. Sci. Med.

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Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38

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Quality of life and diabetes

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Diabetes Care

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Quality of life and pharmacoeconomics in clinical trials

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Diabetes Care

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QoL Newsletter

Original article
Quality of life in type 2 diabetes patients under intensive multitherapy