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Aims Aim of the present study was to evaluate the impact of once-weekly semaglutide on different end-points indicative of metabolic control, cardiovascular risk, dietary behavior, and treatment satisfaction in T2DM. Methods This was a retrospective observational study conducted in a diabetes clinic. Changes in HbA1c, fasting blood glucose (FBG), weight, blood pressure, lipid profile, and number of antihypertensive drugs at 32 weeks (T1) after the first prescription of semaglutide (T0) were analyzed. Furthermore, at T1 patients were asked to fill-in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) and the Control of Eating Questionnaire (COEQ). Results Overall, 104 patients were identified (mean age 63.6 ± 10.4 years, 58.7% men, diabetes duration 12.7 ± 8.7 years). After 32 weeks of treatment with semaglutide, HbA1c levels were reduced by 1.38%, FBG by − 56.53 mg/dl, weight by 6.03 kg. Systolic and diastolic blood pressure, total, HDL-, LDL-, and non –HDL cholesterol, and triglycerides significantly improved. The number of glucose-lowering and antihypertensive drugs also decreased. At T1, DTSQ score was 32.23 ± 1.44, whereas COEQ indicated low levels of hunger and good control of eating. Conclusions The study documented benefits of semaglutide on metabolic control and multiple CV risk factors, simplification of therapeutic schemes and high satisfaction with diabetes treatment, and eating behaviors indicative of healthy diet and reduced food intake.

Supplemental material, sj-docx-10-tam-10.1177_17588359231165978 for The pan-immune-inflammation value is associated with clinical outcomes in patients with advanced TNBC treated with first-line, platinum-based chemotherapy: an institutional retrospective analysis by Leonardo Provenzano, Riccardo Lobefaro, Francesca Ligorio, Emma Zattarin, Luca Zambelli, Caterina Sposetti, Daniele Presti, Giulia Montelatici, Angela Ficchì, Antonia Martinetti, Alessio Arata, Marta Del Vecchio, Claudia Lauria Pantano, Barbara Formisano, Giulia Valeria Bianchi, Giuseppe Capri, Filippo de Braud, Claudio Vernieri and Giovanni Fucà in Therapeutic Advances in Medical Oncology

Introduction Coronavirus disease 19 (COVID-19), due to severe acute respiratory syndrome-coronavirus 2 (SARS-CoV2), comprises a broad spectrum of clinical presentation ranging from flu-like syndrome to organ failure. The risk of coinfections is high and responsible for a worse prognosis, mainly in the case of bacterial involvement and in the presence of particular comorbidity. We present the clinical, laboratory, radiologic characteristic along with therapeutic management of a patient with COVID-19 and Staphylococcus aureus coinfection. Case presentation A 55-year-old Caucasian woman was admitted to our hospital due to a two-day history of fever and acute dyspnea with severe respiratory failure worsened after the administration of atezolizumab and nab-paclitaxel. Her medical history comprehended a triple negative, BRCA1-related, PD-L1 positive right breast cancer with multiple bone metastasis, causing bone marrow infiltration-related severe pancytopenia. Her physical examination revealed scattered wheezes, rales, and bilateral dry crackles in the middle and lower lung fields and lower limb paresis. The body mass index was 30 kg/m2 and arterial blood gas evaluation revealed a stage III acute respiratory distress syndrome. Microbiological specimens revealed a Staphylococcus aureus positivity from endotracheal aspirate. The chest computed tomography (CT) scan showed the presence of large areas of parenchymal consolidation and aerial bronchogram, bilateral "ground glass" areas reaching the highest extension on the upper and middle zones. The high clinical and radiological suspicion of COVID-19 along with the negative result of nasopharyngeal specimen make necessary an endotracheal aspirate resulting positive for SARS-CoV2. Patient started an antimicrobial treatment and lopinavir-ritonavir plus hydroxychloroquine but, unfortunately, died five days after hospital admission. Conclusion The high risk of mortality of our patient was due to viral-bacterial coinfection, advanced cancer status with active immunotherapy. This case highlights the need for a prompt clinical, laboratory, and radiological evaluation to allow a correct diagnosis and start a specific therapy.

Introduction: Thyroid ultrasound (US) is crucial for clinical decision in the management of thyroid nodules. In this cross-sectional study, we aimed to test if the evaluation of thyroid nodules’ vascularization could improve the risk stratification ability of the American College of Radiology (ACR) TI-RADS classification system. Methods: A total of 873 thyroid nodules undergoing fine-needle aspiration were classified according to ACR TI-RADS US classification. Three types of vascularization were identified: type 0, no vascular signals; type 1, peripheral vascular signals; type 2, peripheral and intralesional vascular signals. Cytology specimens were evaluated conforming to the Italian Reporting System for Thyroid Cytology, and TIR3b, TIR4, and TIR5 were defined as high risk for malignancy. Odds ratios (ORs) with 95% confidence intervals (CI) and the areas under the receiver operating characteristic curves (ROC-AUC) for high-risk cytology categories were calculated. Results: The 3 vascular patterns were differently distributed within the cytology categories: 52.4% of TIR1c, 15.9% of TIR2, 5.9% of TIR3a, 6.7% of TIR3b, 12.5% of TIR4, and 28.9% of TIR5 nodules had no vascular signals (p < 0.001). Nodule vascularity alone was not associated with a higher risk of malignant cytology (OR [95% CI] 0.75 [0.43–1.32], p = 0.32), without differences between peripheral (OR [95% CI] 0.65 [0.35–1.20]) and intranodular (OR [95% CI] 0.88 [0.48–1.62]) vascularization (p = 0.22). The ROC-AUC (95% CI) for the diagnosis of malignant cytology was similar when considering TI-RADS classification alone (0.736 [0.684–0.786]) and when considering TI-RADS classification plus the presence/absence of vascular signals (0.736 [0.683–0.789], p value for differences between the ROC-AUCs: 0.91). Among TR1, TR2, and TR3 TI-RADS classes, no nodules without vascular signals showed a malignant cytology, allowing the identification of nodules with benign cytology with 100% specificity within these US classes. Conclusions: Color Doppler study of thyroid nodules does not improve the risk stratification ability of the ACR TI-RADS US classification system.

Background: No direct prospective studies comparing laser ablation (LA) and radiofrequency ablation (RFA) for debulking benign non-functioning thyroid nodules (BNTNs) exist. We aimed at comparing t...

Background: Advanced triple-negative breast cancer (aTNBC) has a poor prognosis; thus, there is a need to identify novel biomarkers to guide future research and improve clinical outcomes. Objectives: We tested the prognostic ability of an emerging, complete blood count (CBC)-based inflammatory biomarker, the pan-immune-inflammation value (PIV), in patients with aTNBC treated with first-line, platinum-based chemotherapy. Design: This was a retrospective, monocentric, observational study. Methods: We included consecutive aTNBC patients treated with platinum-based, first-line chemotherapy at our Institution, and for whom baseline (C1) CBC data were available. We collected CBC data early on-treatment, when available. PIV was calculated as: (neutrophil count × platelet count × monocyte count)/lymphocyte count. Patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (aBC) were included in a control, non-TNBC cohort. Results: A total of 78 aTNBC patients were included. When evaluated as a continuous variable, PIV-C1 was associated with worse overall survival (OS; p Conclusion: PIV has a promising prognostic discrimination ability in aTNBC patients treated with first-line, platinum-based chemotherapy. Both baseline and early on-treatment PIV are associated with clinical outcomes and may be exploited for creating PIV-based risk classifiers if further validated.

ABSTRACT Background: Up to now, there are no direct prospective studies comparing Laser (LA) and radiofrequency ablation (RFA). We aimed to compare, in a head- to-head clinical trial, the efficacy and safety of both techniques in a population affected by solid or predominantly solid benign non-functioning thyroid nodules (BNTN). Methods. LARA is a six-month, single-use, randomized, superiority, open-label, parallel trial. We enrolled subjects with a solitary BNTN or dominant nodule characterized by pressure symptoms/cosmetic problems or patients without symptoms who experienced a volume increase >20% in one year. Nodules underwent core needle biopsy (CNB) to evaluate the histological architecture. Patients were randomly assigned (1:1) to receive treatment with either LA or RFA. The primary endpoint was to evaluate the difference in nodule volume reduction between the RF and the LA group at six months. Moreover, we aimed to assess the differences between groups in the rate of nodules with greater than 50% base volume reduction (successful rate) at six months after treatment. ClinicalTrials.gov: number NCT02714946. Findings: From January 2016 to November 2018, 60 patients were randomly assigned (30 participants per group). In the whole study population, the average volume of nodules was 25 ml. The two groups were similar in terms of basal nodule volume, thyroid function, histology, symptoms/cosmetic score and procedure time. At six months, participants in the RFA group showed a reduction volume of 64·3% (95% CI: 57·5% - 71·2%) compared to 53·2% (95% CI: 47·2% - 59·2%) in the LA group (p= 0·015) and this difference was also confirmed in a linear regression model adjusted for age, baseline volume and proportion of cellular component (Laser vs. RFA percent change Delta= -12·8, P=0·018).We have not recorded any significant difference in terms of successful rate at six months after treatment between the two groups (86·7% in the RFA vs 66·7% in the LA, p=0·127). At six months, both symptoms and cosmetic scores improved (compressive symptom score: 2·13 vs 3·9 for RFA, p < 0·001; 2·4 vs. 3·87 for LA, p < 0·001; cosmetic score: 1·65 vs 2·2 for RFA p Interpretation: Both techniques are very effective in reducing the volume of thyroid nodules. RFA appears to be more effective than LA, but both techniques showed no difference in terms of success rate six months after treatment. The safety of the two techniques is very satisfactory.

Background and importance Chimeric antigen receptor (CAR) T cell therapy is being studied for the treatment of haematologic malignancies. CARs are synthetic receptors that reveal the specificity, purpose and metabolism of T cells. The first step in making CAR-T cells is to insert a gene into the cell in order to express a new antigen binding site on its surface and to redirect the T cell to the new target. Since CAR-T is a personalised therapy, the medicine should be administered to the patient for whom it was intended. For this reason, the clinical pharmacist plays a key role in clinical surveillance, care coordination and patient education. Aim and objectives The aim of this work was to assess the pharmacist as risk manager in a CAR-T multidisciplinary team comprising professionals who take care of cancer patients. Beyond the implementation of the hospital system, the pharmacist is essential in the follow-up of patients after administration because of the complexity of the side effects as well as antidote management. Material and methods Cytokine release syndrome (CRS) is one of the most common side effects of CAR-T therapy, in which there is a fast release of cytokines involved in the inflammatory process. It seems that the onset of CRS is related to the efficacy of the therapy, even though this side effect is extremely dangerous and on target. Pharmacists should manage CRS by ensuring the supply of tocilizumab, a monoclonal antibody against interleukin 6 indicated as an antidote, or by using situximab, off-label. Results Currently, six patients are being treated with CAR-T cell therapy and safety outcomes are ongoing. All have had CRS reactions and received tocilizumab. Conclusion and relevance Based on these results, the immediate availability of antidote and timely treatment of CRS reactions (mandatory activity for the pharmacist) is necessary to ensure the therapeutic and safety benefits for patients. The study shows the essential role of the pharmacist in covering the risks of this type of therapy and in reducing the seriousness of side effects in an innovative therapy such as CAR-T cells. References and/or acknowledgements No conflict of interest.

A large proportion of patients with coronary artery disease treated with elective percutaneous coronary intervention have high residual platelet reactivity1 and endothelial dysfunction, which might represent the link to the occurrence of ischemic events.2 This is even more the case for patients with diabetes mellitus, in whom more potent P2Y12 receptor inhibitors have been proposed with promising results in terms of reduced platelet reactivity.3 Nevertheless, whether this enhanced platelet inhibition alsomight be beneficial to the endothelial function is yet unknown. CLOTILDIA (Clopidogrel High Dose Versus Ticagrelor for Antiplatelet Maintenance in Diabetic Patients)4 was a single-center, prospective, randomized, open label, crossover study, enrolling patients with type2 diabetes mellitus and stable coronary artery disease treated with percutaneous coronary intervention and drug-eluting stent implantation. Patients were recruited at least 1month after percutaneous coronary intervention (3.8±2.1 months), while they were still on dual-antiplatelet therapy with aspirin (100 mg/d) and clopidogrel (75 mg/d). At study entry (T0), with the use ofa computer-based randomization system, patients were assigned randomlyto receive either 90 mg ticagrelor twice daily or clopidogrel 150 mg once daily for 14 …

Background Acute pericarditis may occur frequently after viral infections. To our knowledge, influenza B virus infection complicated by pericarditis without myocardial involvement has never been reported. We report the first case of life-threatening pericarditis caused by influenza B virus infection. Case presentation A 48-years-old woman with trisomy 21 and ostium primum atrial septal defect was transferred from Cardiology to our Internal Medicine Department for severe pericardial effusion unresponsive to ibuprofen and colchicine. Based on the recent patient history of flu-like syndrome, and presence of pleuro-pericardial effusion, a viral etiology was suspected. Laboratory evaluation and molecular assay of tracheal aspirate identified influenza B virus. Therefore, the ongoing metilprednisolone and colchicine therapy was implemented with oseltamivir with progressive patient improvement and no evidence of pericardial effusion recurrence during follow-up. Conclusions Especially in autumn and winter periods, clinicians should include Influenza B virus infection on differential diagnosis of pericarditis with large pericardial effusion.

Objective: To determine clinical diabetes-related risk factors for fragility fractures in type 1 diabetes (T1D). Research design and methods: History of bone fragility fractures occurring after T1D diagnosis was assessed by questionnaire in this cross-sectional study in 600 T1D subjects. Glycated hemoglobin A1c (HbA1c)over the previous 5 years was used as an index of long-term glycemic control; complications were adjudicated by physician assessment. Multinomial logistic regression models were used to assess the associations between diabetes-related risk factors and fracture history. Results: One-hundred-eleven patients (18.5%)reported at least one fracture; of these 73.8% had only one and 26.2% had more than one fracture. Average age was 41.9 ± 12.8 years, with even gender distribution; disease duration was 19.9 ± 12.0 years; and BMI was 24.4 ± 3.7 kg/m2. The 5-year average HbA1c was 7.6 ± 1.0% (60 mmol/mol). In adjusted models, reduced risk for 1 fracture was found in those with higher creatinine clearance rate (CCr)(RRR 0.22 [95% CI: 0.06–0.83]for 1 unit increase in lnCCr, p = 0.03)and increased risk in those with neuropathy (RRR 2.57 [1.21–5.46], p = 0.01). Increased risk for ≥2 fractures was found in subjects in the highest tertile of HbA1c (≥7.9%)compared with the lowest tertile (≤7.17%)(RRR 3.50 [1.04–11.7], p = 0.04)and of disease duration (≥26 years versus

Contrast-induced acute kidney injury (CI-AKI) is defined as an acute kidney failure following iodine-based contrast medium administration determining relevant health and socio-sanitary implications. Knowledge of pathophysiology, early diagnosis, and prevention in patients at risk are critical points in CI-AKI management. Determination of risk and functional kidney evaluation must precede every iodine-based contrast medium (CM) administration in order to eventually introduce medical prophylaxis. Furthermore, early laboratoristic evaluation after iodine-based CM exposure should be performed for a prompt identification of acute kidney injury. Therefore, clinicians must know and strictly follow valid recommendations to minimize the development of complications.

Objective Thyroid ultrasound is crucial for clinical decision in the management of thyroid nodules. In this study, we aimed to estimate and compare the performance of ATA, AACE/ACE/AME and ACR TI-RADS ultrasound classifications in discriminating nodules with high-risk cytology. Design Cross-sectional study. Methods 1077 thyroid nodules undergoing fine-needle aspiration were classified according to ATA, AACE/ACE/AME and ACR TI-RADS ultrasound classifications by an automated algorithm. Odds ratios (ORs) and receiver operating characteristic (ROC) curves for high-risk cytology categories (TIR3b, TIR4 and TIR5) were calculated for the different US categories and compared. Results Cytological categories of risk increased together with all US classifications’ sonographic patterns (P P P P = 0.008), but similar to AACE/ACE/AME (P = 0.287). ATA classification was not able to classify 54 nodules, which showed a significant 7 times higher risk of high-risk cytology than the ‘very low suspicion’ nodules (OR: 7.20 (95% confidence interval: 2.44–21.24), P Conclusions The ACR TI-RADS classification system has the highest area under the ROC curve for the identification of cytological high-risk nodules. ATA classification leaves ‘unclassified’ nodules at relatively high risk of malignancy.

RATIONALE Marfan syndrome is a rare cause of heart failure due to primary or secondary cardiomyopathy. Recently, sacubitril/valsartan-an angiotensin receptor blocker-neprilysin inhibitor-has been added in clinical practice as a standard therapy for heart failure. To our knowledge, there are no data on sacubitril/valsartan's effects on cardiovascular outcomes in patients with Marfan syndrome. PATIENT CONCERNS A 24-year-old man was admitted to our Internal Medicine Department due to dyspnea, ascites, and leg swelling. Arterial blood gas analysis revealed severe hypoxemia with respiratory and metabolic alkalosis. Hilar congestion was highlighted on chest x-ray. DIAGNOSES Recurrent acute decompensated heart failure with reduced ejection fraction despite optimal medical therapy in Marfan-related cardiomyopathy. INTERVENTIONS AND OUTCOMES Sacubitril/valsartan was added to optimal medical therapy after hemodynamic stabilization allowing progressive clinical, laboratoristic, and echocardiographic improvement. Patient maintained a free survival from heart failure and a good quality of life until 9-month follow-up. LESSONS Sacubitril/valsartan should be effective on pathophysiologic mechanisms and cardiovascular outcomes of Marfan syndrome-related cardiovascular complications.

There are no studies evaluating teriparatide for prevention of post-thyroidectomy hypocalcemia.Our objective was to evaluate whether teriparatide can prevent postsurgical hypocalcemia and shorten the hospitalization in subjects at high risk of hypocalcemia following thyroid surgery.This was a prospective phase II randomized open-label trial.This trial was set on a surgical ward.Twenty-six subjects (six males, 20 females) with intact PTH lower than10 pg/ml 4 hours after thyroidectomy were included.Subjects were randomized (1:1) to receive SC administration of 20 mcg of teriparatide every 12 hours until the discharge (treatment group) or to follow standard clinical care (control group).Adjusted serum calcium, duration of hospitalization, and calcium/calcitriol supplementation were measured.Overall, the incidence of hypocalcemia was 3/13 in treatment group and 11/13 in the control group (P = .006). Treated patients had a lower risk of hypocalcemia than controls (relative risk, 0.26 [95% confidence interval, 0.09-0.723)]). The median duration of hospitalization was 3 days (interquartile range, 1) in control subjects and 2 days (interquartile range, 0) in treated subjects (P = .012). One month after discharge, 10/13 subjects in the treatment group had stopped calcium carbonate supplements, while only 5/13 in the control group had discontinued calcium. The ANOVA for repeated measures showed a significant difference in calcium supplements between groups at 1-month visit (P = .04) as well as a significant difference between discharge and 1-month visit in the treatment group (P for interaction time group = .04) Conclusions: Teriparatide may prevent postsurgical hypocalcemia, shorten the duration of hospitalization, and reduce the need for calcium and vitamin D supplementation after discharge in high risk subjects after thyroid surgery.

To improve insulin sensitivity, insulin-sensitizing drugs such as metformin are commonly used in overweight and obese T1D patients. Similarly to metformin, D-chiro-inositol (DCI), as putative mediator of intracellular insulin action, can act as insulin sensitizer. The aim of this pilot study was to evaluate the hypothesis that DCI plus folic acid may improve glucose control reducing insulin resistance in overweight or obese T1D patients.A 24-week randomized control trial was carried out in 26 overweight or obese T1D patients, undergoing intensive insulin therapy. Patients were randomized to 1 g DCI plus 400 mcg folic acid once daily (treated group) or to 400 mcg folic acid only once daily (control group). The primary end point was to evaluate the efficacy of DCI on metabolic control as assessed by HbA1c. As secondary endpoints, BMI and insulin requirement (IR) were evaluated. Paired t test (two tailed) and analysis of variance were used to evaluate differences in HbA1c, BMI and IR at different time points.A significant reduction in HbA1c levels in treated group versus control group (7.5% ± 0.9 vs. 7.9% ± 1.7, respectively, p 0.05) was observed. However, no significant reduction in BMI and IR was observed [(BMI 25.7 ± 2.8 vs. 26.7 ± 1.0, respectively, p NS); (IR 0.52 ± 0.26 vs. 0.52 ± 0.19, respectively, p NS)].This trial demonstrated for the first time that DCI plus folic acid oral supplementation can improve metabolic control in overweight T1D patients. CLINICALTRIAL.NCT02730949.

Introduction Fine needle aspiration (FNA) is the most accurate and cost-effective method for evaluating thyroid nodules. We have reported a rare complication related to the procedure: severe retropharyngeal cellulitis. Case presentation A thirty-five-year-old female was admitted to hospital with hoarseness, laryngeal stridor and dyspnea without fever that emerged about 3 days after a first diagnostic FNA. After the procedure, the patient felt her voice became hoarse and 1 day before presentation began to have dyspnea, without fever. It had become difficult for her to swallow solids, and she felt as if food was sticking in her throat. In the emergency room, hematochemical tests and CT scan of the neck/mediastinum had been performed. This showed leukocytosis with neutrophilia and a severe cellulitis framework with involvement of the laterocervical neck area and in particular, the invasion of the retropharynx and the upper part of the mediastinum. The patient was admitted in hospital for an anti-inflammatory therapy with cortisone and antibiotic therapy. Conclusions For the first time to our knowledge, we have reported a severe retropharyngeal and upper mediastinum cellulitis, probably due to the FNA procedure in an immunocompetent young woman.

Recent evidence demonstrating an increased fracture risk among obese individuals suggests that adipose tissue may negatively impact bone health, challenging the traditional paradigm of fat mass playing a protective role towards bone health. White adipose tissue, far from being a mere energy depot, is a dynamic tissue actively implicated in metabolic reactions, and in fact secretes several hormones called adipokines and inflammatory factors that may in turn promote bone resorption. More specifically, Visceral Adipose Tissue (VAT) may potentially prove detrimental. It is widely acknowledged that obesity is positively associated to many chronic disorders such as metabolic syndrome, dyslipidemia and type 2 diabetes, conditions that could themselves affect bone health. Although aging is largely known to decrease bone strength, little is yet known on the mechanisms via which obesity and its comorbidities may contribute to such damage. Given the exponentially growing obesity rate in recent years and the increased life expectancy of western countries it appears of utmost importance to timely focus on this topic.

Ultrasonography (US) changes have been noted in patients with autoimmune thyroiditis (AT). Here, we report that some patients with late stage AT have a distinctive, previously unreported finding on US that we call the "hypoechoic triangle sign" (HET).On US, the HET sign was characterized as a well-defined area of low echogenicity, about 10 mm in diameter, between the lateral margin of one or both thyroid lobes, the medial wall of the carotid artery, and, posteriorly, the prevertebral muscles. Twenty-six patients with AT who had the HET sign (Group 1) were compared with 71 patients with AT who had normal serum thyrotropin (TSH) and free thyroid hormones levels (Group 2) and with 154 normal controls (Group 3). TSH was tested at least twice, first as part of their regular clinical care and then in follow-up. The groups were similar in terms of age, sex, and body mass index. Thyroid volume by US, TSH, free triiodothyronine, free thyroxine, antithyroid antibodies, and l-thyroxine treatment were evaluated. Sonographic gray-scale analysis and three-dimensional reconstruction of HET region were performed in five of the Group 1 patients.Thyroid volume was significantly smaller (p 0.01) in Group 1 than in Groups 2 and 3 (6.9 ± 2.18 vs. 10.4 ± 2.1 and 9.8 ± 2.5 mL, respectively). In Group 1, 61.5% of subjects were taking l-thyroxine for hypothyroidism; none of the Group 2 or 3 patients was taking thyroid hormone. Serum TSH was significantly higher (p 0.01) in Group 1 versus Groups 2 and 3 (3.6 ± 1.3 vs. 2.18 ± 1.4 and 1.9 ± 1.1 mIU/L, respectively). None of the Group 2 or 3 patients had the HET sign. Gray-scale US demonstrated an overlap between HET zone and the surrounding muscle tissue.The HET sign seems to be specific for overt thyroid failure in patients with AT as it was not noted in patients with AT not having overt thyroid failure. The incidental finding of the HET sign during cervical US examination should prompt obtaining thyroid function tests to rule out hypothyroidism. Our study provides data regarding specificity but not sensitivity of the HET sign for AT and thyroid failure because a consecutive group of AT patients with thyroid failure was not studied. In addition, the specificity of the HET sign for AT needs to be evaluated further by studying a diverse group of thyroid diseases.

This document has been developed by a group of Italian diabetologists with extensive experience in continuous subcutaneous insulin infusion (CSII) therapy to provide indications for the clinical management of CSII in diabetic patients (both type 1 and type 2) based on delivery mode operating in Italy. Although the potential benefits of pump therapy in achieving glycemic goals is now accepted, such results cannot be obtained without specific knowledge and skills being conveyed to patients during ad hoc educational training. To ensure that these new technologies reach their full effectiveness, as demonstrated theoretically and clinically, a careful assessment of the overall therapeutic and educational process is required, in both qualitative and quantitative terms. Therefore, to ensure the cost-effectiveness of insulin pump therapy and to justify reimbursement of therapy costs by the National Health System in Italy, in this article we present a model for diabetes and healthcare centers to follow that provides for different levels of expertise in the field of CSII therapy. This model will guarantee the provision of excellent care during insulin pump therapies, thus representing the basis for a successful outcome and expansion of this form of insulin treatment in patients with diabetes while also keeping costs under control.

Background To investigate serum concentrations of high-sensitive C-reactive protein (CRP) and alpha(1)-acid glycoprotein (AGP) in patients with T1DM, at diagnosis and after 12 months of intensive insulin therapy (T12). Methods CRP and AGP were measured in 44 recent onset T1DM patients (26M/18F, mean age 14.9 ± 9.1 years), and 44 age- and sex-matched controls, using a highly sensitive immunonephelometric assay. Results There were no significant differences in the concentrations of high-sensitive C-reactive protein (hs-CRP) and AGP between patients and controls. hs-CRP levels significantly increased in patients at T12 compared to the levels at diagnosis [0.69 (0.14–15.5) versus 0.43 (0.14–7.47) mg/L, p < 0.05; for males: 0.77 (0.14–15.5) versus 0.35 (0.14–7.47) mg/L, p < 0.05; for females the increase was not significant]. AGP levels were not different at T12 compared to diagnosis. No significant correlations were found between hs-CRP and body mass index (BMI), C-peptide, glycosylated haemoglobin, or insulin dose. A strong correlation was found between hs-CRP values at diagnosis and those at T12 (ρ = 0.73, p < 0.001); indeed, patients with hs-CRP levels above the 50th percentile at diagnosis showed significantly increased hs-CRP values at T12 compared to patients with baseline hs-CRP levels under the 50th percentile [1.61 (0.18–15.5) versus 0.16 (0.14–1.92) mg/L, p < 0.0001)], and to controls [0.55 (0.14–6.50), p = 0.001]. Conclusions This is the first report showing that, despite good metabolic control, 1 year of overt T1DM is sufficient to increase hs-CRP levels, especially in males. hs-CRP levels at diagnosis is a predictor for the values observed at 12 months, suggesting the possibility to select a subgroup of patients requiring strict follow-up for cardiovascular complications. Copyright © 2006 John Wiley & Sons, Ltd.

Poor glycemic control is associated with unfavorable outcome in patients undergoing percutaneous coronary intervention (PCI), irrespective of diabetes mellitus. However a complete assessment of glycemic status may not be fully described by glycated hemoglobin or fasting blood glucose levels, whereas daily glycemic fluctuations may influence cardiovascular risk and have even more deleterious effects than sustained hyperglycemia. Thus, this paper investigated the effectiveness of a continuous glucose monitoring (CGM), registering the mean level of glycemic values but also the extent of glucose excursions during coronary revascularization, in detecting periprocedural outcome such as renal or myocardial damage, assessed by serum creatinine, neutrophil gelatinase-associated lipocalin (NGAL), and troponin I levels. High glycemic variability (GV) has been associated with worse postprocedural creatinine and NGAL variations. Moreover, GV, and predominantly hypoglycemic variations, has been observed to increase in patients with periprocedural myocardial infarction. Thus, our study investigated the usefulness of CGM in the setting of PCI where an optimal glycemic control should be achieved in order to prevent complications and improve outcome.

Aims To investigate whether small nerve fibre degeneration detected using corneal confocal microscopy is associated with cardiac autonomic neuropathy in people with Type 1 diabetes. Methods Thirty-six people with Type 1 diabetes and 20 age- and sex-matched healthy control subjects were enrolled. Tests to determine heart rate response to deep-breathing (expiratory-to-inspiratory ratio), heart rate response to lying-to-stand test (30:15 ratio) and blood pressure response to standing were performed to detect cardiac autonomic neuropathy. Corneal confocal microscopy was performed to assess: corneal nerve density and corneal nerve beadings; branching pattern; and nerve fibre tortuosity. Results Compared with control participants, participants with Type 1 diabetes had fewer (mean ± sd 45.4 ± 20.2 vs 92.0 ± 22.7 fibres/mm2; P