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Aims: Glargine 300 U/mL (Gla-300) has been recently approved for use in children and adolescents with type 1 diabetes (T1D). However, real-world effectiveness data are scarce, and aim of this analysis was to assess clinical outcomes in young patients with T1D switching from 1st generation basal insulin (1BI) to Gla-300., Methods: ISPED CARD is a retrospective, multicenter study, based on data anonymously extracted from Electronic Medical Records. The study involved a network of 20 pediatric diabetes centers. Data on all patients aged < 18 years with T1D switching from 1BI to Gla-300 were analyzed to assess clinical characteristics at the switch and changes after 6 and 12 months in glycated hemoglobin (HbA1c), fasting blood glucose (FBG), and standardized body mass index (BMI/SDS). Titration of basal and short-acting insulin doses was also evaluated., Results: Overall, 200 patients were identified. The mean age at the switch to Gla-300 was 13 years, and mean duration of diabetes was 3.9 years. Average HbA1c levels at switch were 8.8%. After 6 months, HbA1c levels decreased by - 0.88% (95% CI - 1.28; - 0.48; p < 0.0001). The benefit was maintained after 12 months from the switch (mean reduction of HbA1c levels - 0.80%, 95% CI - 1.25; - 0.35, p = 0.0006). Trends of reduction in FBG levels were also evidenced both at 6 months and 12 months. No significant changes in short-acting and basal insulin doses were documented., Conclusions: The study provides the first real-world evidence of the effectiveness of Gla-300 in children and adolescents with T1D previously treated with 1BI. The benefits in terms of HbA1c levels reduction were substantial, and sustained after 12 months. Additional benefits can be expected by improving the titration of insulin doses., (© 2024. Springer-Verlag Italia S.r.l., part of Springer Nature.)

Aim: In Italy, the ISPED CARD initiative was launched to measure and improve quality of care in children and adolescents with type 1 diabetes., Methods: Process and outcome indicators and the related information derived from electronic medical records were identified. A network of pediatric diabetes centers was created on a voluntary basis., Results: Overall, 20 centers provided data on 3284 patients aged <  = 18 years. HbA1c was monitored ≥ 2/year in 81.2% of the cases. BMI was monitored ≥ 1/year in 99.0%, lipid profile in 45.3%, and blood pressure in 91.7%. Pubertal status, albuminuria, eye examination, and screening of celiac disease and thyroiditis were underreported. From 2017 to 2021, average HbA1c levels decreased from 7.8 ± 1.2 to 7.6 ± 1.3%, while patients with LDL cholesterol > 100 mg/dl increased from 18.9 to 36.7%. Prevalence of patients with elevated blood pressure and BMI/SDS values also increased. In 2021, 44.7% of patients were treated with the newest basal insulins, while use of regular human insulin had dropped to 7.7%. Use of insulin pump remained stable (37.9%)., Conclusions: This report documents the feasibility of the ISPED CARD initiative and shows lights and shadows in the care provided. Improving care, increasing number of centers, and ameliorating data recording represent future challenges., (© 2024. The Author(s).)

Objectives: Practice-to-recommendations gaps exist in croup management and have not been critically investigated. This study examined the therapeutic management of croup among a national sample of Italian pediatric providers., Methods: A survey was administered online to a sample of primary care and hospital-based pediatricians. Demographic data, perception regarding disease severity, treatment and knowledge of croup, choices of croup treatment medications, and knowledge of and adherence to treatment recommendations were compared between hospital and primary care pediatricians. Oral corticosteroids alone, oral corticosteroids with or without nebulized epinephrine and nebulized epinephrine plus oral or inhaled corticosteroids were considered the correct management in mild, moderate and severe croup, respectively. The determinants for correct management were examined using multivariate logistic regression analysis., Results: Six hundred forty-nine pediatricians answered at least 50% of the survey questions and were included in the analysis. Providers reported extensive use of inhaled corticosteroids for mild and moderate croup. Recommended treatment for mild, moderate and severe croup was administered in 46/647 (7.1%), 181/645 (28.0%) and 263/643 (40.9%) participants, respectively. Provider's age and knowledge of Westley Croup Score were significant predictors for correct management of mild croup. Being a hospital pediatrician and perception of croup as a clinically relevant condition were significant for moderate croup., Conclusions: Significant differences exist between recommended guidelines and clinical practice in croup management. This study suggests wide variability in both the treatment of croup and clinical decision making strategies among hospital and primary care pediatricians. Addressing this issue could lead to noteworthy clinical and economic benefits., Competing Interests: Declaration of competing interest none., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Aims: Telemedicine is advocated as a fundamental tool in modern clinical management. However, data on the effects of telemedicine vs face-to-face consultation on clinical outcomes in type 2 diabetes (T2DM) are still uncertain. This paper describes the use of telemedicine during the 2020 COVID-19 emergency and compares volume activity and quality indicators of diabetes care between face-to-face vs telemedicine counseling in the large cohort of T2DM patients from the AMD Annals Initiative., Methods: Demographic and clinical characteristics, including laboratory parameters, rate of the screening of long-term complications, current therapies and the Q-score, a validated score that measures the overall quality of care, were compared between 364,898 patients attending face-to-face consultation and 46,424 on telemedicine, during the COVID-19 pandemic., Results: Patients on telemedicine showed lower HbA1c levels (7.1 ± 1.2 % vs 7.3 ± 1.3 %, p < 0.0001), and they were less frequently treated with metformin, GLP1-RAs and SGLT2i and more frequently with DPP4i. The telemedicine group showed reduced monitoring of the various parameters considered as process indicators, especially, eye and foot examination. The proportion of patients with a good quality of care (Q score > 25) was higher among those receiving face-to-face consultation. Moreover, in the telemedicine group, all major clinical outcomes remained stable when further compared to those collected in the year 2019, when the same patients underwent a regular face-to-face consultation, suggesting that the care provided through telemedicine did not negatively affect the most important parameters., Conclusions: During the COVID-19 pandemic, telemedicine provided an acceptable quality of diabetes care, comparable to that of patients attending face-to-face consultation, although a less frequent screening of complications seems to have occurred in subjects consulted by telemedicine., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.)

Aim: To construct predictive models of diabetes complications (DCs) by big data machine learning, based on electronic medical records., Methods: Six groups of DCs were considered: eye complications, cardiovascular, cerebrovascular, and peripheral vascular disease, nephropathy, diabetic neuropathy. A supervised, tree-based learning approach (XGBoost) was used to predict the onset of each complication within 5 years (task 1). Furthermore, a separate prediction for early (within 2 years) and late (3-5 years) onset of complication (task 2) was performed. A dataset of 147.664 patients seen during 15 years by 23 centers was used. External validation was performed in five additional centers. Models were evaluated by considering accuracy, sensitivity, specificity, and area under the ROC curve (AUC)., Results: For all DCs considered, the predictive models in task 1 showed an accuracy > 70 %, and AUC largely exceeded 0.80, reaching 0.97 for nephropathy. For task 2, all predictive models showed an accuracy > 70 % and an AUC > 0.85. Sensitivity in predicting the early occurrence of the complication ranged between 83.2 % (peripheral vascular disease) and 88.5 % (nephropathy)., Conclusions: Machine learning approach offers the opportunity to identify patients at greater risk of complications. This can help overcoming clinical inertia and improving the quality of diabetes care., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Objective: The health and economic burden of type 2 diabetes is of global significance. Many people with type 2 diabetes eventually need insulin to help reduce their risk of serious associated complications. However, barriers to the initiation and/or optimization of insulin expose people with diabetes to sustained hyperglycemia. In this review, we investigated how new and future technologies may provide opportunities to help overcome these barriers to the initiation and/or optimization of insulin., Methods: A focused literature search of PubMed and key scientific congresses was conducted. Software tools and devices developed to support the initiation and/or optimization of insulin were identified by manually filtering >300 publications and conference abstracts., Results: Most software tools have been developed for smartphone platforms. At present, published data suggest that the use of these technologies is associated with equivalent or improved glycemic outcomes compared with standard care, with additional benefits such as reduced time burden and improved knowledge of diabetes among health care providers. However, there remains paucity of good-quality evidence. Most new devices to support insulin therapy help track the dose and timing of insulin., Conclusion: New digital health tools may help to reduce barriers to optimal insulin therapy. An integrated solution that connects glucose monitoring, dose recording, and titration advice as well as records comorbidities and lifestyle factors has the potential to reduce the complexity and burden of treatment and may improve adherence to titration and treatment, resulting in better outcomes for people with diabetes., (Copyright © 2022 AACE. Published by Elsevier Inc. All rights reserved.)

In recent years, off-label and unlicensed drug use has extensively developed in the paediatric population. For a long time, clinical trials in the paediatric population were considered complicated to perform because of ethical problems, causing frequent off-label use. Off-label drug use remains an important public health issue, especially for children with rare conditions or with diseases not responsive to conventional treatments. The present paper is a narrative review of the literature of off-label drug use in children. The aim of our study is to summarize the main works dealing with the off-label use of biological drugs in paediatrics. Further studies analyzing their efficacy, safety, and cost-benefit ratios are needed to extend the use of biological therapies to the paediatric population.