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Aims: Periodical screening for diabetic retinopathy (DR) by an ophthalmologist is expensive and demanding. Automated DR image evaluation with Artificial Intelligence tools may represent a clinical and cost-effective alternative for the detection of retinopathy. We aimed to evaluate the accuracy and reliability of a machine learning algorithm. Methods: This was an observational diagnostic precision study that compared human grader classification with that of DAIRET®, an algorithm nested in an electronic medical record powered by Retmarker SA. Retinal images were taken from 637 consecutive patients attending a routine annual diabetic visit between June 2021 and February 2023. They were manually graded by an ophthalmologist following the International Clinical Diabetic Retinopathy Severity Scale and the results were compared with those of the AI responses. The main outcome measures were screening performance, such as sensitivity and specificity and diagnostic accuracy by 95% confidence intervals. Results: The rate of cases classified as ungradable was 1.2%, a figure consistent with the literature. DAIRET® sensitivity in the detection of cases of referable DR (moderate and above, "sight-threatening" forms of retinopathy) was equal to 1 (100%). The specificity, that is the true negative rate of absence of DR, was 80 ± 0.04. Conclusions: DAIRET® achieved excellent sensitivity for referable retinopathy compared with that of human graders. This is undoubtedly the key finding of the study and translates into the certainty that no patient in need of the ophthalmologist is misdiagnosed as negative. It also had sufficient specificity to represent a cost-effective alternative to manual grade alone. [ABSTRACT FROM AUTHOR]

The question whether antidiabetes drugs can cause acute pancreatitis dates back to the 1970s. Recently, old concerns have re-emerged following claims that use of incretins, a new class of drugs for type 2 diabetes, might increase the relative risk of acute pancreatitis up to 30-fold. Given that diabetes is per se a potent risk factor for acute pancreatitis and that drug-related acute pancreatitis is rare and difficult to diagnose, we searched the medical databases for information linking acute pancreatitis and type 2 diabetes drugs. Among the biguanides, both phenformin and metformin (the latter in patients with renal insufficiency) have been cited in case reports as a potential cause of acute pancreatitis. Sulphonylureas, as both entire class and single compound (glibenclamide), have also been found in cohort studies to increase its risk. No direct link was found between pancreatic damage and therapy with metaglinide, acarbose, pramlintide or SGLT-2 inhibitors. In animal models, thiazolinediones have demonstrated proprieties to attenuate pancreatic damage, opening perspectives for their use in treating acute pancreatitis in humans. Several case reports and the US Food and Drug Administration pharmacovigilance database indicate an association between acute pancreatitis and incretins, dipeptidyl peptidase-4 ( DPP-4) inhibitors, and GLP-1 receptor agonists. To date, however, a clear-cut odds ratio for this association has been reported in only one of eight pharmacoepidemiological studies. Finally, none of the intervention trials investigating these compounds, including two large randomized controlled trials with cardiovascular endpoints, confirmed the purportedly increased risk of acute pancreatitis with incretin use. [ABSTRACT FROM AUTHOR]

Aims The Associazione Medici Diabetologi-annals initiative is a physician-led quality-of-care improvement scheme that has been shown to improve HbA1c concentration, blood pressure, lipid profiles and BMI in enrolled people with Type 2 diabetes. The present analysis investigated the long-term cost-effectiveness of enrolling people with Type 2 diabetes in the Associazione Medici Diabetologi-annals initiative compared with conventional management. Methods Long-term projections of clinical outcomes and direct costs (in 2010 Euros) were made using a published and validated model of Type 2 diabetes in people with Type 2 diabetes who were either enrolled in the Associazione Medici Diabetologi-annals initiative or who were receiving conventional management. Treatment effects were based on mean changes from baseline seen at 5 years after enrolment in the scheme. Costs and clinical outcomes were discounted at 3% per annum. Results The Associazione Medici Diabetologi-annals initiative was associated with improvements in mean discounted life expectancy and quality-adjusted life expectancy of 0.55 years (95% CI 0.54-0.57) years and 0.48 quality-adjusted life years (95% CI 0.46-0.49), respectively, compared with conventional management. Whilst treatment costs were higher in the Associazione Medici Diabetologi-annals arm, this was offset by savings as a result of the reduced incidence and treatment of diabetes-related complications. The Associazione Medici Diabetologi-annals initiative was found to be cost-saving over patient lifetimes compared with conventional management [€ 37,289 (95% CI 37,205-37,372) vs € 41,075 (95% CI 40,956-41,155)]. Conclusions Long-term projections indicate that the physician-led Associazione Medici Diabetologi-annals initiative represents a cost-saving method of improving long-term clinical outcomes compared with conventional management of people with Type 2 diabetes in Italy. [ABSTRACT FROM AUTHOR]

The time to achieve good metabolic control after diagnosis is essential for type 2 diabetes patients because it can influence long-term prognosis. This study aimed to elucidate the predictive role of several clinical and organization factors in normalizing metabolism within 6 months. A multi-centered, retrospective, observational study on 960 patients, with diabetes duration of 12 months or less, consecutively seen in 123 Italian clinics, was undertaken. Information about clinic’s organization, along with data abstracted from medical records at enrollment (first visit) and after 6 months (follow-up visit), was collected. At 6 months, HbA1c dropped by -3.1 ± 2.2 points in those who achieved HbA1c <7 % (responders), whereas in non-responders (HbA1c ≥7 %), the mean reduction was -1.8 ± 1.9. The intervention markedly reduced lipids, blood pressure, BMI, and waist circumference, especially in responders. The presence of a diabetes team correlated with a likelihood of HbA1c normalization (OR 1.94, 1.17–3.22). By contrast, indicators of advanced disease such as previous retinopathy (0.53, 0.29–0.98), use of secretagogues (0.40, 0.25–0.64), high levels of HbA1c at first visit and related insulin use emerged as adverse factors. Early detection of diabetes, along with human resources and organization, was found to play a crucial role in rapidly attaining good metabolic control. [ABSTRACT FROM AUTHOR]

To evaluate the potential impact of physicians' age on global cardiovascular (CV) risk management in the population of the Evaluation of Final Feasible Effect of Ultra Control Training and Sensitisation (EFFECTUS) study. Involved physicians were stratified into three age groups (≤ 45, 46-55 and > 55 years), and asked to provide clinical data covering the first 10 adult outpatients, consecutively seen in May 2006. Overall 1078 physicians, among whom 219 (20%) were aged ≤ 45, 658 (61%) between 46 and 55, and 201 (19%) > 55 years, collected data of 9904 outpatients (46.5% female patients, aged 67 ± 9 years), who were distributed into three corresponding groups: 2010 (20%), 6111 (62%) and 1783 (18%), respectively. A higher prevalence of myocardial infarction and stroke was recorded by younger physicians rather than those aged > 46 years. Older physicians frequently recommended life-style changes, whereas a higher number of antihypertensive, antiplatelet, glucose and lipid-lowering prescriptions was prescribed by physicians aged ≤ 45 years. This analysis of the EFFECTUS study indicates a higher prevalence of vascular diseases among outpatients who were followed by younger physicians, who prescribed a higher number of CV drugs than older physicians. These older physicians have more attitude for prescribing favourable life-style changes than younger physicians. [ABSTRACT FROM AUTHOR]

Diabet. Med. 27, 1041–1048 (2010) Aims We evaluated the impact of a continuous quality improvement effort implemented by a network of Italian diabetes clinics operating in the national healthcare system. Methods This was a controlled before-and-after study involving 95 centres, of which 67 joined the initiative since 2004 (group A) and 18 were first involved in 2007 (group B, control). All centres used electronic medical record systems. Information on quality indicators was extracted for the period 2004–2007. Data were centrally analysed anonymously and results were published annually. Each centre’s performance was ranked against the ‘best performers’. We compared quality indicators between the two groups of centres over 4 years. Results Over 100 000 Type 2 diabetes mellitus patients were evaluated annually. The proportion of patients with glycated haemoglobin levels < 7% increased by 6% in group A (2007–2004 difference) and by 1.3% in group B. The proportion of patients with low-density lipoprotein-cholesterol < 100 mg/dl improved by over 10% in both groups. The rate of patients with blood pressure values ≤ 130/85 mmHg increased in group A (+6.4%), but not in group B (–1.4%). The use of insulin increased in group A only (+5.2%), while the use of statins increased by over 20% in both groups. Conclusions A physician-led quality improvement effort, based on the systematic evaluation of routine data, is effective in improving the performance of a large number of diabetes clinics. The small percentage increase in the number of patients at target, if applied to large numbers of patients, would translate into a significant impact on public health. [ABSTRACT FROM AUTHOR]

Objective: To investigate the role of clinical and socioeconomic variables as determinants of adherence to recommended diabetes care guidelines and assess differences in the process of care between diabetologists and general practitioners.Research Design and Methods: We identified diabetic residents in Torino, Italy, as of 31 July 2003, using multiple independent data sources. We collected data on several laboratory tests and specialist medical examinations registered during the subsequent 12 months and performed regression analyses to identify associations with quality-of-care indicators based on existing guidelines.Results: After 1 year, only 35.8% of patients had undergone a comprehensive assessment. In the multivariate models, factors independently and significantly associated with lower quality of care were age >or=75 years (prevalence rate ratio [PRR] 0.66 [95% CI 0.61-0.70]) and established cardiovascular disease (0.89 [0.86-0.93]). Disease severity (PRR for insulin-treated patients 1.45 [1.38-1.53]) and diabetologist consultation (PRR 3.34 [3.17-3.53]) were positively associated with high quality of care. No clear association emerged between sex and socioeconomic status. These differences were strongly reduced in patients receiving diabetologist care compared with patients receiving general practitioner care only.Conclusions: Despite widespread availability of guidelines and simple screening procedures, a nonnegligible portion of the diabetic population, namely elderly individuals and patients with less severe forms of the disease, are not properly cared for. As practitioners in diabetes centers are more likely to adhere to guidelines than general practitioners, quality in the diabetes care process can be improved by increasing the intensity of disease management programs, with greater participation by general practitioners. [ABSTRACT FROM AUTHOR]

OBJECTIVE: Cardiovascular disease (CVD) is the main cause of morbidity/mortality in diabetes. We set forth to determine incidence and identify predictors (including microvascular complications and treatment) of first coronary heart disease (CHD) event in CVD-free type 2 diabetic patients. RESEARCH DESIGN AND METHODS: A cohort of 6,032 women and 5,612 men, sampled from a nationwide network of hospital-based diabetes clinics, was followed up for 4 years. Baseline assessment included retinopathy, nephropathy, and foot ulcers. First CHD events (myocardial infarction, coronary artery bypass grafting, percutaneous transluminal coronary angioplasty, and electrocardiogram-proven angina) were analyzed for 29,069 person-years. RESULTS: The age-standardized incidence rate (per 1,000 person-years) of first CHD event (n = 881) was 28.8 (95% CI 5.4-32.2) in men and 23.3 (20.2-26.4) in women. Major CHD (myocardial infarction, coronary artery bypass grafting, and percutaneous transluminal coronary angioplasty) was less frequent in women (5.8 [4.3-7.2]) than in men (13.1 [10.9-15.4]; a sex ratio of 0.5 [0.4-0.6]). Incidence rates of all outcomes were higher in patients with microvascular complications (for major CHD, age-adjusted rate ratios were 1.6 [1.2-2.21] in men and 1.5 [1.0-2.2] in women). By multivariate Cox analysis, age and diabetes duration were risk predictors common in both sexes. In men, glycemic control and treated hypertension were additional independent risk factors, but residing in the south was associated with a significant 29% risk reduction. In women, higher triglycerides/lower HDL cholesterol and microvascular complications were independent risk factors. CONCLUSIONS: In CVD-free patients with type 2 diabetes, risk of first CHD event depends on sex, geographic location, and presence of microvascular disease. Hyperglycemia and hypertension, particularly in men, and diabetic dyslipidemia, especially in women, are risk factors amenable to more aggressive treatment. [ABSTRACT FROM AUTHOR]

Aims We evaluated whether differences in the use of specialized care have an impact on rates of hospitalization for diabetes. Methods In 2001 we determined the number of hours of second-level diabetes care provided by local health units (LHU) of the Piemonte Region (Italy) and created an indicator of the mean weekly number of hours of care per 1000 residents for each LHU. From the database of the Piemonte Hospital Information System, we extracted all hospitalizations for 20–75-year-old residents with a main discharge diagnosis of diabetes mellitus ( n = 3457). For each LHU, we calculated the hospitalization rate, the percentage of unplanned hospital admissions, the mean length of hospital stay, the percentage of day-hospital admissions and the percentage of re-admissions for diabetes-related complications within 6 months. The association between the indicators of specialized care and of hospital care was studied using two-level generalized hierarchical linear regression models (level 1: patient; level 2: LHU), taking into account the clustered nature of the data. Age, educational level and an indicator of disease severity were used as adjustment parameters. Results In the tertile of LHUs that provided the greatest number of hours of diabetes care, we observed, compared with the lowest tertile fewer unplanned hospital admissions [odds ratio (OR) 0.37; 95% confidence interval (CI) 0.20–0.67], greater day-hospital use (OR 1.99; 0.72–5.49) and a lower mean duration of hospital stay (coefficient −0.26; 95% CI −0.45 to −0.06), independently of the socio-economic level, which was a separate risk factor. Conclusions The intensity of specialized diabetes care greatly influences the characteristics of hospitalization. Diabet. Med. 23, 377–383 (2006) [ABSTRACT FROM AUTHOR]

Type 2 diabetes is associated with at least a twofold increase in risk of coronary heart disease (CHD). We aimed to estimate the prevalence of CHD in the population of Type 2 diabetics cared for by the Italian network of outpatient diabetic units. The DAI ( Diabetes and Informatics study group, Italian Association of Diabetologists, and Italian National Institute of Health) study is a multicentre cohort study of patients with Type 2 diabetes. Patients were classified as having CHD if they had: (i) a history for hospital admission for either an acute myocardial infarction (AMI) or angina; (ii) a positive ECG for prior AMI or angina; (iii) a positive history for coronary artery bypass graft; or (iv) a positive history for percutaneous transluminal coronary angioplasty. A cohort of 19 468 patients was analysed: 3157 patients had CHD. The majority of events (80%) had occurred after the diagnosis of diabetes and were considered in the CHD prevalence estimate. The prevalence of CHD, adjusted by age and sex, was 9.9%: 11.0% male and 9.0% female. Angina without AMI occurred in 1306 patients; this condition was more frequent in females while a documented AMI was more frequent in males. Therapeutic procedures were performed more frequently in males. A positive association with CHD was found for gender, age at visit, duration of diabetes, hypertension, relatives with CHD, tryglicerides and microvascular complications. The prevalence of CHD in this cohort is lower than previously reported; nevertheless, patients attending the diabetic care units may not be fully representative of the general diabetic population in Italy. Revascularization is less frequent in females than in males; microvascular complications and a worse metabolic control are significantly associated with CHD. Diabet. Med. (2004) [ABSTRACT FROM AUTHOR]

Although well-defined in the general population, correlates of total homocysteine (tHcy) plasma concentration have not been sufficiently evaluated in diabetes. We investigated factors potentially associated with tHcy concentration in a cohort of type 2 diabetic subjects. The common methylene tetrahydrofolate reductase (MTHFR) C677T polymorphism, fasting tHcy, vitamin B12 and folate plasma levels were assessed in 312 diabetic subjects, whose clinical, metabolic and lifestyle information was also available. The MTHFR genotype distribution was comparable to the Hardy–Weinberg equilibrium, with an overall TT homozygous frequency of 22%. Fasting tHcy concentration was significantly higher in men than in women ( P < 0·001). Multivariate-adjusted tHcy concentration was significantly different across the quartiles of age ( P < 0·001), folate ( P = 0·01), vitamin B12 ( P = 0·03), creatinine concentrations ( P = 0·001) and smoking ( P = 0·02). Overall, significant trends were noted for creatinine clearance ( P for trend = 0·02) and systolic blood pressure (BP) (unadjusted P for trend = 0·01), whereas no differences were noted according to BMI, diastolic BP, presence of hypertension, and diabetes-related variables, such as diabetes duration, fasting glucose and glycated haemoglobin concentrations, current treatment and diabetes long-term complications. Total homocysteine levels significantly correlated with age, systolic BP, vitamin B12, creatinine and creatinine clearance, but only age, creatinine, folate and vitamin B12 levels were independently associated with tHcy concentration in stepwise regression analysis. Age, creatinine, folate, vitamin B12, and to a minor extent, sex, smoking, TT genotype and systolic BP were significantly associated with Hcy plasma concentration in type 2 diabetes, whereas no significant associations were noted with diabetes-related variables. Eur J Clin Invest 2004; 34 (3): 197–204 [ABSTRACT FROM AUTHOR]

Diabetes mellitus is one of the major causes of morbidity and mortality in EU/EFTA countries. Monitoring risk factors for diabetes and its complications will offer the possibility to evaluate the development in time as well as the influence of possible interventions. In this investigation a list with core and secondary indicators is proposed. Availability of these indicators and their data sources is discussed. An important variability of data sources is used in EU/EFTA countries, interfering with the comparability of the outcome. Further harmonisation as well as continuous evaluation of data sources will be necessary to provide reliable tools to monitor diabetes mellitus and its outcome on a routine basis. [ABSTRACT FROM AUTHOR]

Diabetes mellitus is one of the major causes of morbidity and mortality in EU/EFTA countries. Monitoring risk factors for diabetes and its complications will offer the possibility to evaluate the development in time as well as the influence of possible interventions. In this investigation a list with core and secondary indicators is proposed. Availability of these indicators and their data sources is discussed. An important variability of data sources is used in EU/EFTA countries, interfering with the comparability of the outcome. Further harmonisation as well as continuous evaluation of data sources will be necessary to provide reliable tools to monitor diabetes mellitus and its outcome on a routine basis. [ABSTRACT FROM AUTHOR]