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Background: International guidelines for diabetes care emphasize the urgency of promptly achieving and sustaining adequate glycemic control to reduce the occurrence of micro/macrovascular complications in patients with type 2 diabetes mellitus (T2DM). However, data from the Italian Association of Medical Diabetologists (AMD) Annals reveal that only 47% of T2DM patients reach appropriate glycemic targets, with approximately 30% relying on insulin therapy, either solely or in combination. This artificial intelligence analysis seeks to assess the potential impact of timely insulin initiation in all eligible patients via a "what-if" scenario simulation, leveraging real-world data. Methods: This retrospective cohort study utilized the AMD Annals database, comprising 1,186,247 T2DM patients from 2005 to 2019. Employing the Logic Learning Machine (LLM), we simulated timely insulin use for all eligible patients, estimating its effect on glycemic control after 12 months within a cohort of 85,239 patients. Of these, 20,015 were employed for the machine learning phase and 65,224 for simulation. Results: Within the simulated scenario, the introduction of appropriate insulin therapy led to a noteworthy projected 17% increase in patients meeting the metabolic target after 12 months from therapy initiation within the cohort of 65,224 individuals. The LLM's projection envisages 32,851 potential patients achieving the target (hemoglobin glycated < 7.5%) after 12 months, compared to 21,453 patients observed in real-world cases. The receiver operating characteristic (ROC) curve analysis for this model demonstrated modest performance, with an area under the curve (AUC) value of 70.4%. Conclusions: This study reaffirms the significance of combatting therapeutic inertia in managing T2DM patients. Early insulinization, when clinically appropriate, markedly enhances patients' metabolic goals at the 12-month follow-up. [ABSTRACT FROM AUTHOR]

2 TABLE Raw incidence rates (IR) of type 1 diabetes in Piedmont (Italy) by 100 000 residents and rate ratios (RR), comparison between before and during the COVID pandemic years. Nevertheless, over the 3 years of the COVID-19 pandemic, the overall incidence of DM1 has remained ~17% higher than before the pandemic, suggesting further work to understand the link between coronaviruses and diabetes is a priority. Keywords: database research; observational; population study; study; type 1 diabetes EN database research observational population study study type 1 diabetes 3068 3070 3 09/06/23 20231001 NES 231001 BACKGROUND There have now been several reports that the incidence of type 1 diabetes (DM1) increased during the COVID-19 pandemic, particularly in young children,[[1], [3]] although some data are conflicting.[4] Overall, however, there is emerging evidence from diabetes registries that this observed increase is real. [Extracted from the article]

Incidence rate ratios (RRs) were calculated as the ratio between the incidence of each year with the appropriate incidences in 2017 (reference year). Increased incidence of type 1 diabetes in 2 years of COVID-19 pandemic Comparisons of pooled incidence between three non-COVID years (2017-2019) and the two COVID-19 years (2020-2021) confirm the above significant increase in the total population. [Extracted from the article]

Introduction: Recent guidelines for the treatment of type 2 diabetes mellitus (T2DM) provide evidence supporting limited use of sulphonylureas (SUs), especially in specific risk patient categories, yet data from national registries still suggest their widespread use. The aim of this study was to investigate characteristics of patients with diabetes treated with SUs and quantify the proportion of patients that met the recommendations for use of SUs by recent guidelines and of those presenting characteristics representing an inappropriate prescription risk (IPR). Methods: A multicenter, retrospective, cross-sectional, observational study in patients with T2DM receiving treatment with SUs (as monotherapy or in combination with another diabetes therapy) was conducted between 2017 and 2018 in 22 outpatient diabetes clinics across Italy. Exclusion criteria were type 1 diabetes, diabetes mellitus secondary to other conditions, and presence of severe/life-threatening diseases. Results: A total of 510 patients with T2DM (306 men, 204 women; mean age ± standard deviation 69.8 ± 9.3 years) who were receiving treatment with a SU (as monotherapy or in combination therapy) were assessed in the study. Overall, 70.6% [n = 360; 95% confidence interval (CI) 66.4%, 74.5%] were assessed to have an IPR. Of these, approximately half presented one factor for risk of inappropriate prescription, and 27 and 10.6% presented two and three factors, respectively. In terms of factors contributing to the total burden of risk of inappropriate treatment with SUs, 37.5% (95% CI 33.2%, 41.8%) of all patients were obese; 33.3% (95% CI 29.3%, 37.6%)] were aged ≥ 75 years; 18.6% (95% CI 15.3%, 22.3%) had a history of cardiovascular disease; 14.1% (95% CI 11.2%, 17.4%) had chronic renal insufficiency; 1.8% (95% CI 0.8%, 3.3%) had a history of severe hypoglycemia; 1.8% (95% CI 0.8%; 3.3%) had cognitive impairment; and 2.4% (95% CI 1.2%, 4.1%) had a risky occupation. Conclusions: The results of this study provide evidence of a high rate of inappropriate SU prescription risk among patients with T2DM, especially among those with overweight/obesity, older age, history of cardiovascular disease, and hypoglycemia. [ABSTRACT FROM AUTHOR]

Aims: The aim of our study was to estimate the overall rate of first hospitalizations for diabetic foot (DF) regardless of the outcome in amputations, as well as the mortality rate with their determinants in the period 2012–2016 in Piedmont Region in Italy. Methods: The study included all the subjects registered in the Regional Diabetes Registry and alive as at January 1, 2012. DF cases were identified by record linkage with the regional hospital discharge database. Incident cases of diabetic foot were followed up for mortality. Results: The 5-year rates were 1762, 324, and 343 × 100,000 patients for first hospitalization without amputations, with major amputations, and with minor amputations, respectively. Patients not undergoing amputations were more than 70% of the cohort. Patients with the more severe stages of diabetes and those with low education were at higher risk of each type of hospitalization. The risk of death during a mean follow-up of 2.5 years was about 16, 18, and 30% among patients without amputations, with major amputations, and with minor amputations, respectively. Males, insulin-treated patients, those affected with severe diabetes complications, particularly on dialysis, and those with lower levels of education were at higher risk. Conclusions: The heavier burden of DF on hospitalizations is due to cases without amputation, a condition that is seldom considered in the diabetes literature. The severity of diabetes, preexisting complications, and low educational levels are associated with both first hospitalization and subsequent survival at any level of severity of DF. [ABSTRACT FROM AUTHOR]

Purpose: A multicentre, randomized, double-blind, placebo-controlled, parallel-group study aimed to define the potential positive effect of dipeptidyl peptidase-4 inhibition on left ventricular systolic function (LVSF) beyond glycemic control in type 2 diabetes mellitus (T2DM) (DYDA 2™ trial). Methods: Individuals with fairly controlled T2DM and asymptomatic impaired LVSF were randomized in a 1:1 ratio to receive for 48 weeks either linagliptin 5 mg daily or placebo, in addition to their stable diabetes therapy. Eligibility criteria were age ≥ 40 years, history of T2DM with a duration of at least 6 months, HbA1c ≤ 8.0% (≤ 64 mmol/mol), no history or clinical signs/symptoms of cardiac disease, evidence at baseline echocardiography of concentric LV geometry (relative wall thickness ≥ 0.42), and impaired LVSF defined as midwall fractional shortening (MFS) ≤ 15%. The primary end-point was the modification from baseline to 48 weeks of MFS. As an exploratory analysis, significant changes in LV global longitudinal strain and global circumferential strain, measured by speckle tracking echocardiography, were also considered. Secondary objectives were changes in diastolic and/or in systolic longitudinal function as measured by tissue Doppler. Results: A total of 188 patients were enrolled. They were predominantly males, mildly obese, with typical insulin-resistance co-morbidities such as hypertension and dyslipidemia. Mean relative wall thickness was 0.51 ± 0.09 and mean MFS 13.3% ± 2.5. Conclusions: DYDA 2 is the first randomized, double-blind, placebo-controlled trial to explore the effect of a dipeptidyl peptidase-4 inhibitor on LVSF in T2DM patients in primary prevention regardless of glycemic control. The main characteristics of the enrolled population are reported. Trial registration: ClinicalTrial.gov Identifier: NCT02851745. [ABSTRACT FROM AUTHOR]

Aims: To study the incidence of and the factors associated with renal dialysis and transplantation in type 1 (T1DM) and type 2 diabetes (T2DM).Methods: Data on individuals who had received dialysis treatment or renal transplant between 1 January 2004 and 31 December 2013 were extracted from the regional administrative database (Piedmont, Italy), and the crude (cumulative) incidence of dialysis was calculated. Overall cumulative survival was estimated using the Kaplan-Meier method and compared using the log-rank test. Poisson regression was used to estimate adjusted rate ratios for potential predictors of renal transplant or death. Results: A total of 7401 persons started dialysis treatment during the decade, with a 10-year cumulative crude incidence of 16.8/100,000. Incidence was stable and consistently eightfold higher in persons with T2DM (tenfold higher in T1DM) compared to those without diabetes. The risk of dialysis in T1DM was about double that of T2DM. The mortality rate was significantly higher in diabetics than in non-diabetes (241.4/1000 vs. 153.99/1000 person-years). During the decade 2004-2013, 893 patients underwent a kidney transplant. Transplantation rates were significantly lower for diabetics than non-diabetics (16.5/1000 vs. 42.9/1000 person-years). Conclusions: In the past decade, the incidence of dialysis has stabilized in both the general population and in diabetics in whom it remains far higher by comparison. Also mortality rates are higher, with a worse prognosis for T1DM. Diabetes poses a barrier to allotransplantation, and efforts should be made to overcome this limitation. [ABSTRACT FROM AUTHOR]

Correction to: Increased incidence of type 1 diabetes in 2 years of COVID-19 pandemic B Correction to: Acta Diabetologica b https://doi.org/10.1007/s00592-022-01986-w The given name and family name of co-authors corrected in original publication. The original article can be found online at https://doi.org/10.1007/s00592-022-01986-w. [Extracted from the article]

We evaluated gender-differences in quality of type 1 diabetes (T1DM) care. Starting from electronic medical records of 300 centers, 5 process indicators, 3 favorable and 6 unfavorable intermediate outcomes, 6 treatment intensity/appropriateness measures and an overall quality score were measured. The likelihood of women vs. men (reference class) to be monitored, to reach outcomes, or to be treated has been investigated through multilevel logistic regression analyses; results are expressed as Odd Ratios (ORs) and 95% confidence intervals (95%CIs). The inter-center variability in the achievement of the unfavorable outcomes was also investigated. Overall, 28,802 subjects were analyzed (45.5% women). Women and men had similar age (44.5±16.0 vs. 45.0±17.0 years) and diabetes duration (18.3±13.0 vs. 18.8±13.0 years). No between-gender differences were found in process indicators. As for intermediate outcomes, women showed 33% higher likelihood of having HbA1c ≥8.0% (OR = 1.33; 95%CI: 1.25–1.43), 29% lower risk of blood pressure ≥140/90 mmHg (OR = 0.71; 95%CI: 0.65–0.77) and 27% lower risk of micro/macroalbuminuria (OR = 0.73; 95%CI: 0.65–0.81) than men, while BMI, LDL-c and GFR did not significantly differ; treatment intensity/appropriateness was not systematically different between genders; overall quality score was similar in men and women. Consistently across centers a larger proportion of women than men had HbA1c ≥8.0%, while a smaller proportion had BP ≥140/90 mmHg. No gender-disparities were found in process measures and improvements are required in both genders. The systematic worse metabolic control in women and worse blood pressure in men suggest that pathophysiologic differences rather than the care provided might explain these differences. [ABSTRACT FROM AUTHOR]

Aims: Beta-cell dysfunction is an early event in the natural history of type 2 diabetes. However, its progression is variable and potentially influenced by several clinical factors. We report the baseline data of the BetaDecline study, an Italian prospective multicenter study on clinical predictors of beta-cell dysfunction in type 2 diabetes. Materials and Methods: Clinical, lifestyle, and laboratory data, including circulating levels of inflammatory markers and non-esterified fatty acids, were collected in 507 type 2 diabetic outpatients on stable treatment with oral hypoglycemic drugs or diet for more than 1 year. Beta-cell dysfunction was evaluated by calculating the proinsulin/insulin ratio (P/I). Results: At baseline, the subjects in the upper PI/I ratio quartile were more likely to be men and receiving secretagogue drugs; they also showed a borderline longer diabetes duration (P = 0.06) and higher serum levels of glycated hemoglobin (HbA1c), fasting blood glucose, and triglycerides. An inverse trend across all PI/I quartiles was noted for BMI and serum levels of total cholesterol (T-C), LDL-C, HDL-C and C reactive protein (CRP), and with homeostatic model assessment (HOMA-B) and HOMA of insulin resistance (HOMA-IR) values (P<0.05 for all). At multivariate analysis, the risk of having a P/I ratio in the upper quartile was higher in the subjects on secretagogue drugs (odds ratio [OR] 4.2; 95% confidence interval [CI], 2.6–6.9) and in the males (OR 1.8; 95% CI, 1.1–2.9). Conclusions: In the BetaDecline study population, baseline higher PI/I values, a marker of beta-cell dysfunction, were more frequent in men and in patients on secretagogues drugs. Follow-up of this cohort will allow the identification of clinical predictors of beta-cell failure in type 2 diabetic outpatients. [ABSTRACT FROM AUTHOR]

The role of hyperhomocysteinemia as a risk factor for diabetic long-term complications has not been sufficiently evaluated in prospective studies, considering specific correlates of homocysteine (tHcy) concentration and traditional cardiovascular disease (CVD) risk factors. Fasting tHcy, vitamin B12 and folate plasma levels, the common methylenetetrahydrofolate reductase (MTHFR) C677T gene polymorphism, as well as clinical and lifestyle information were assessed in 216 type 2 diabetic patients attending two outpatient clinics, who had a follow-up evaluation at 65 ± 9 months for the incidence of macroangiopathy. At basal evaluation, mild hyperhomocysteinemia (tHcy ≥ 15 μmol/l) was diagnosed in 21.3% of participants. At follow-up, hyperhomocysteinemia and the distribution of MTHFR C677T genotype did not significantly differ according to the incidence of macroangiopathy. Multiple variables adjusted ORs (95% CI) for CVD associated with mild hyperhomocysteinemia were 1.01 (0.37-2.82); P > 0.05; those associated with MTHFR TT genotype were 0.46 (0.15-1.38); P > 0.05. Although the prevalence of hyperhomocysteinemia was higher in diabetic men (26.9%) than in women (16.1%; P > 0.05), similar results were also observed in a separate sex-analysis. At the multivariate analysis, including in the model other potential CVD risk factors, only creatinine clearance was a significant risk factor for the development of macroangiopathy. In this cohort of diabetic subjects, mild hyperhomocysteinemia and the MTHFR TT genotype are not significant risk factors for the development of macroangiopathy; impaired renal function was confirmed as a significant predictor of this complication. [ABSTRACT FROM AUTHOR]

Introduction: The EFFECTUS (Evaluation of Final Feasible Effect of Control Training and Ultra Sensitisation) study is an educational programme, aimed at implementing global cardiovascular risk management in daily clinical practice in Italy. Objective: To evaluate global cardiovascular risk management among physicians stratified according to the use of conventional (CS) or electronic (ES) support for clinical data collection and registration. Methods: Involved physicians were asked to submit data into a study-designed, case-report form, covering the first ten adult outpatients consecutively seen in May 2006. A case-report form was made available on CS or ES, depending on physicians' preferences and attitudes. All available data were centrally analysed for global cardiovascular risk assessment and cardiovascular risk profile characterization. Results: Overall, 1078 physicians (27% females, aged 50 - 7 years) collected data from 9904 outpatients (46.5% females, aged 67 - 9 years). 299 physicians used CS for 2672 (27.0%) patients, whereas the remaining 779 physicians used ES for 7232 patients (73.0%). A higher prevalence of obesity, diabetes mellitus, ischaemic heart disease (mostly previous myocardial infarction) and stroke, was recorded by physicians using CS compared with those using ES. Blood pressure and fasting glucose levels were significantly higher in the CS group than in the ES group, although a significantly higher number of antihypertensive, glucose and lipid-lowering prescriptions was reported in the former than in the latter group. Physicians using ES paid significantly more attention to collecting data concerning cardiovascular risk factors, which were also more up-to-date compared with those recorded by physicians using CS. Conclusions: This sub-analysis of the EFFECTUS study indicates a higher attention to the collection and management of data on major cardiovascular risk factors in physicians using ES than in those using CS. Our findings may suggest a potential way to improve global cardiovascular risk management in the clinical practices of Italy. [ABSTRACT FROM AUTHOR]

Background: Cardiovascular diseases still represent the leading cause of morbidity and mortality, worldwide. Early detection and appropriate management of major cardiovascular risk factors in clinical practice may improve preventive strategies in Western countries, including Italy. Objective: To evaluate the prevalence of major cardiovascular risk factors and their impact on routine clinical practice of Italian general practitioners (GPs), cardiologists and diabetologists. Methods: The study involved physicians who participated in an educational project on cardiovascular risk management, the EFFECTUS (Evaluation of Final Feasible Effect of Control Training and Ultra- Sensitisation) programme. Physicians were asked to report data already available in their clinical records of the first ten consecutive adult outpatients during May 2006. Data collection included patients' full medical history and therapies, physical examination (anthropometric parameters and blood pressure levels), laboratory results and diagnostic examinations. Data were then centrally analysed for global cardiovascular risk evaluation and cardiovascular risk profile characterization. The present study provides data from the baseline records of the EFFECTUS programme. Results: A total of 1078 physicians (73% males and 27% females, mean age 50 - 7 years), of which 841 (78%) were GPs, 140 (13%) cardiologists and 97 (9%) diabetologists, included data from 9904 outpatients (5300 males and 4604 females, mean age 67 - 9 years). In the overall population, 2504 (25%) subjects were obese, 7436 (75%) had hypertension, 5873 (59%) had dyslipidaemia, 3681 (37%) had diabetes mellitus and 2633 (27%) had a history of ischaemic heart disease, while 1102 (11%) and 1247 (13%) had cerebral or peripheral artery disease, respectively. Significant differences were reported in the prevalence of detected cardiovascular risk factors among physicians operating in different clinical settings. Moreover, different clinical habits were recorded. Conclusions: The present analysis illustrates a very high prevalence of cardiovascular risk factors, irrespective of the clinical settings in which patients were followed, in a vast Italian population. The study also describes differences in management of cardiovascular risk factors among physicians operating in different clinical settings. [ABSTRACT FROM AUTHOR]