Impact of hypoglycemic episodes on health-related quality of life of type-2 diabetes mellitus patients: development and validation of a specific QoLHYPO© questionnaire.

BACKGROUND: Hypoglycemia is a limiting factor to achieving optimal glycemic control in patients with type-2 diabetes mellitus (T2DM), increasing risk of death and complications, reducing health-related quality of life (HRQoL) and work productivity and increasing healthcare costs. The study's primary objective was to develop and validate a specific questionnaire to assess the impact of hypoglycemia on the HRQoL of T2DM patients (QoLHYPO© questionnaire). METHODS: A two-phase multicenter prospective, longitudinal, observational, epidemiologic study of consecutively enrolled patients, not involving any drug, was conducted: In phase 1 (questionnaire development), patients who had given their written informed consent, who were at least 30 years of age, had been diagnosed with T2DM at least 5 years prior, had an HbA1c test in the previous 3 months, and a hypoglycemic episode in the previous 6 months were included. To validate the questionnaire and assess reliability and responsiveness, phase 2 included two cohorts of patients. Patients in the reliability cohort would likely have stable clinical course during the 3 weeks following inclusion in the study and patients in the responsiveness cohort would likely experience changes in their clinical course in the 3 months after enrollment. RESULTS: Phase 1 included 168 patients: 10 attended semi-structured interviews, 18 for face validity, and 140 for the pilot test (Rasch analysis). Phase 2 included 227 patients: 142 in the reliability cohort and 85 in the responsiveness cohort. Of the 37 items initially included in Phase 1, 11 (floor/ceiling effect analysis) and 13 (Rasch analysis) were discarded. The final version of the questionnaire consisted of 13 items. Phase 2 results showed the questionnaire was unidimensional and able to accurately assess HRQoL. Intra-observer reproducibility (ICC = 0.920) and internal consistency (Cronbach's alpha: visit 1 = 0.912; visit 2 = 0.901) were high, showing high reliability. Internal responsiveness was moderate (standardized effect size 0.5-0.8) and external responsiveness was lower (AUC > 0.5; not statistically significant). Minimal clinically important difference (MCID) was estimated to be 3.2 points. CONCLUSIONS: The QoLHYPO© questionnaire is a tool that can be used in routine clinical practice to assess the impact of hypoglycemia on the HRQoL of T2DM patients.

Prevalence of diabetic retinopathy and its relationship with glomerular filtration rate and other risk factors in patients with type 2 diabetes mellitus in Spain. DM2 HOPE study.

AIM: Diabetic retinopathy (DR) is the leading cause of blindness in working age population in developed countries. Albuminuria and estimated glomerular filtration rate (eGFR) have been considered biomarkers for DR. This study aimed to investigate the prevalence of DR and its relationship with eGFR and other risk factors in type 2 diabetic patients (T2DM) in Spain. METHODS: A cross-sectional and descriptive study has been performed in 14,266 patients. Clinical records were reviewed. Demographic data, clinical diagnoses, clinical variables, and results from laboratory tests were recorded. Prevalence rates of DR were calculated. Logistic regression analysis was applied to assess predictors of the DR presence/absence. RESULTS: DR prevalence was 14.9%, being more prevalent in women (p = 0.0087) and in older patients (p < 0.0001). Duration of disease (OR = 5.3, IC95% = 3.8-7.4; p < 0.0001), eGFR < 60 ml/min/1.73 m2 (OR = 2.0, IC95% 1.6-2.4; p < 0.0001), levels of HbA1c ≥ 7% (OR = 1.9, IC95% = 1.5-2.3; p < 0.0001) and high blood pressure (OR = 1.6, IC95% = 1.2-2.1; p = 0.0032) were associated with higher risk of DR. DR was also more frequent in patients taking insulin (32,6% vs. 10,2%; p < 0.0001). CONCLUSION: Around one in seven patients with T2DM has DR after nine years since diagnosis. Time since diagnosis, insulin therapy, cardiovascular profile, and renal dysfunction are associated with DR in patients with T2DM in Spain.