SGLT2-inhibitors are effective and safe in the elderly: The SOLD study.

BACKGROUND AND AIMS: Sodium-glucose co-transporter-2 inhibitors (SGLT2i) may have important benefits for the elderly with type 2 diabetes (T2D), however some safety concerns still limit their use in patients over 70 years of age. The SOLD study (SGLT2i in Older Diabetic patients) is a multicenter study, aimed to evaluate the effectiveness and safety of SGLT2i in the older diabetic patients in a real-life setting. MATERIALS AND METHODS: We analyzed a population of 739 adults (mean age 75.4 ± 3.9 years, M/F 420/319) with T2D, which started a SGLT2i-based treatment after the age of 70, with at least one year of follow-up. Data were collected at baseline, at 6 and 12 months of follow-up. RESULTS: SGLT2i (37.5% Empagliflozin, 35.7% Dapagliflozin, 26.1% Canagliflozin, 0.7% Ertugliflozin) were an add-on therapy to Metformin in 88.6%, to basal insulin in 36.1% and to other antidiabetic drugs in 29.6% of cases. 565 subjects completed the follow up, while 174 (23.5%) discontinued treatment due to adverse events which were SGLT2i related. A statistically significant reduction of glycated hemoglobin (baseline vs 12 months: 7.8 ± 1.1 vs 7.1 ± 0.8%, p < 0.001) and body mass index values (baseline vs 12 months: 29.2 ± 4.7 vs 28.1 ± 4.5 kg/m2, p < 0.001) were evident during follow-up. Overall, estimated glomerular filtration rate remained stable over time, with significant reduction of urinary albumin excretion. In the subgroup of patients which were ≥ 80 years, a significant improvement in glycated hemoglobin values without renal function alterations was evident. Overall discontinuation rate during the follow-up period was different across age groups, being urinary tract infections and worsening of renal function the most common cause. CONCLUSION: SGLT2i are well-tolerated and safe in the elderly and appear as an effective therapeutic option, though some caution is also suggested, especially in more fragile subjects.

Self-care, quality of life and clinical outcomes of type 2 diabetes patients: an observational cross-sectional study.

AIMS: To describe self-care of T2DM patients and to evaluate outcomes associated with self-care in T2DM patients. METHODS: A multicentre cross-sectional study was conducted on a sample of 302 randomly selected T2DM patients. Clinical and socio-demographic data were collected by medical records. The Summary of Diabetes Self-care Activities was used to measure self-care about diet, blood testing, exercise and foot care. The EQ-5D was used to measure perceived quality of life. Multiple regression models were used to evaluate the associations between self-care and body mass index (BMI), glycated haemoglobin (HbA1c), presence of diabetes complications and quality of life (QoL). RESULTS: Self-care was lower about exercise (median = 2.0) and foot care (median = 3.5) than about diet (median = 5.2) and blood testing (median = 4.5). HbA1c was associated with diet (p = 0.025), exercise (p = 0.017) and blood testing (p = 0.034). BMI was associated with exercise (p = 0.0071). Diabetes complications were associated with exercise (p = 0.031) and blood testing (p < 0.009). QoL was associated with exercise (p < 0.0001), blood testing (p = 0.032) and foot care (p = 0.013). CONCLUSIONS: Self-care influences both clinical outcomes and quality of life of T2DM patients. Although exercise is more frequently associated with positive outcomes, it is particularly poor in T2DM population. Blood testing and foot care should be performed to prevent complications and not only when a health problem is already occurred. Interventions aimed to improve exercise are recommended. Further research is needed to explore barriers to exercise.

[Self-care assessment in type-2 diabetes: the Italian translation and validation of the Summary of Diabetes Self-Care Activities]. / Valutazione del self-care nelle persone con diabete di tipo 2: traduzione e validazione della Summary of Diabetes Self-Care Activities.

INTRODUCTION: Self-care represents a key factor for diabetes patients to maintain quality of life and to prevent serious disease complications. Self-care standardized assessment tools are needed to evaluate and to promote self-care in diabetes patients. The Summary of Diabetes Self-Care Activities Scale (SDSCA) has been widely used in clinical and research settings and has been translated in many languages. Validity and reliability of this self-report scale were reported by several studies. However, SDSCA has not yet been translated, culturally adapted and tested in the Italian context. The aim of this methodological research was to translate and to provide a first validation study of the Italian SDSCA - 11 item Version. METHODS: A process of translation, back-translation and semantic concordance evaluation has been performed in order to translate the SDSCA into Italian language in collaboration with the original authors. A cross-sectional survey has been planned to test internal consistency and test -retest reliability on a convenience sample of 80 type 2 diabetes patients. As secondary objective, SDSCA criterion validity has been explored referring to a range of clinical outcomes as glicated emoglobin and presence of complications. RESULTS: A description of respondents' self-care abilities is provided for the whole sample and for sub-groups by gender, age, instruction and income levels. Cronbach's Alfa and Intraclass Correlation Coefficient showed acceptable values considering the multidimensionality of SDSCA. High values were obtained in 3 out of 5 sub-classes of items. As in previous studies, specific diet and physical exercise sub-classes showed limited internal consistency. Cohen's Kappa Concordance Correlation Coefficient and t-test demonstrated high test-retest reliability of SDSCA. Overall SDSCA score did not show significant correlations with selected clinical outcomes; however 3 SDSCA single items significantly correlated with glicated emoglobin, complications and the clinical judgment of the diabetes case manager nurse. CONCLUSION: Further researches involving larger samples are needed to integrate data about Italian SDSCA performances, especially concerning construct and criterion validity. However, based on these preliminary results, SDSCA could find relevant applications in clinical settings to systematically evaluate, to compare over time and to improve specific self-care abilities of diabetes patients.