Elena Calzi

Azienda Ospedaliera Ospedale Maggiore

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Riccardo Bonfanti

Vita-Salute San Raffaele University

Roberto Franceschi

Ospedale Santa Chiara

Maurizio Delvecchio

Ospedale Pediatrico Giovanni XXIII

Andrea Rigamonti

Vita-Salute San Raffaele University

Marco Marigliano

Azienda Ospedaliera Universitaria Integrata Verona

Angela Zanfardino

University of Campania "Luigi Vanvitelli"

Claudio Maffeis

University of Verona

Stefano Passanisi

University of Messina

Barbara Felappi

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Francesco Scialabba

Vita-Salute San Raffaele University

Cooperative Institutions

Azienda Unità Sanitaria Locale Della Romagna

Istituti di Ricovero e Cura a Carattere Scientifico

University of Milan

Virtual High School

University of Padua

University of Bari Aldo Moro

University of Genoa

University of Messina

IRCCS Ospedale San Raffaele

Ospedale dei Bambini Vittore Buzzi

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The impact of COVID-19 on type 1 diabetes and ketoacidosis incidence in pediatric age

Pediatric Diabetes (2021)

Chiara Mameli Giulio Frontino A. Scaramuzza Maddalena Macedoni Ciretta Pelliccia

Introduction: The COVID-19 pandemic has had a significant impact the region of Lombardy, causing more than 16,000 deaths. Fortunately, children, including those with type 1 diabetes (T1DM), were only slightly affected. It is debated as to whether COVID-19 infection may increase the incidence of T1DM in children and whether the conditions during and following lockdown may have led to an increased number of diabetic ketoacidosis (DKA) at onset. Objectives: To assess the impact of COVID-19 on T1DM and DKA incidence. Methods: A network of 11 regional pediatric T1DM clinics collected data in children of ages 0-18 years during the time period between March 1-May 31 in the years 2017-2020. Given that all T1DM children are hospitalized at onset and rarely escape this network of regional clinics, it was possible to define a minimal incidence of T1DM without a secondary source, Results: Number of onsets was stable (2017: 206 cases/year, 2018: 199 cases/year, 2019: 233 cases/year, 2020: 105 cases/5 months). DKA at onset varied between 36 and 40% of new onsets. By comparing the cases in the period March 1-May 302,017-2020, an increase in DKA incidence at onset from 11 to 24/1.7 million (p < 003) was found. The minimum regional incidence of T1DM showed a slight increase from 11.7 to 13.7 cases/100000 (0-18 years of age), comparable to previously collected regional data from 2008. Conclusion: These data suggest that COVID-19 infection in Lombardy was not correlated with an in increased T1DM incidence. Furthermore, the minimum regional incidence of TIDM in ages 0-18 years seems stable in the last 10 years. However, a significant increase in the number of DKA at onset was found, many of which were reported to be severe and probably consequent to delayed hospital presentation due to lockdown restrictions and fear of infection, emphasizing the indirect deleterious impact of pandemics on potentially lifethreatening conditions such as DKA.

Diabetic ketoacidosis

Pandemic

2019-20 coronavirus outbreak

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Type 1 diabetes incidence during COVID-19 pandemic has not been influenced by COVID-19 vaccination in northern Italy region, Lombardy

PLoS ONE (2025)

Chiara Mameli Camilla Valsecchi Danilo Cereda Simona Scarioni Lucia Barcellini

To describe the trends of type 1 diabetes(T1D) incidence in 0-17-year-olds over the years 2020-2023, and the COVID-19 vaccination uptake in Lombardy region. Data about children and adolescents aged 0-17 years who received a diagnosis of T1D from 2020 to 2023 were extracted from the public computerized registry of the healthcare system of the Lombardy Region (Italy). After calculating the annual T1D incidence, the incidence in 2020, prior to the availability of vaccination, was compared to subsequent years. A separate analysis was conducted for the 12-17 age group, the first to receive vaccination. One thousand two hundred seventy-three T1D onsets were recorded. The distribution of T1D showed no significant annual variation by sex (p-trend = 0.338), mean age (9 years, p = 0.537) and age distribution (p-trend = 0.563). T1D incidence [95% CI/100.000] did not significantly change comparing 2020 [18.94/100.000 (CI 16.88-21.18)] with 2021 [21.82/100.000 (CI 18.90-23.44)], 2022 [20.77/100.000 (CI 18.59-23.13)] and 2023 [19.68/100.000 (CI 16.61-20.94)]. No differences in incidence were observed in the 12-17 age group during 2021-2023 when COVID-19 vaccination was available when compared to 2020 (p-wald > 0.05). The COVID-19 vaccination coverage was lower in children with diabetes onset compared to the same-age general population (38 vs 42%). The incidence of T1D in children remained stable during the COVID-19 pandemic, regardless of the uptake of the vaccination.

Pandemic

2019-20 coronavirus outbreak

Betacoronavirus

10.1371/journal.pone.0316340

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Sustained effectiveness of an advanced hybrid closed loop system in a cohort of children and adolescents with type 1 diabetes: a one-year real-world study

Stefano Passanisi Giuseppina Salzano Bruno Bombaci Nicola Minuto Marta Bassi

Objective. To investigate glucose metrics and identify potential predictors of the achievement of glycemic outcomes in children and adolescents during their first 12 months of MiniMed™ 780G use. Research design and methods. In this multicenter, longitudinal, real-world study, 368 children and adolescents with type 1 diabetes starting SmartGuard technology between June 2020 and June 2022 were recruited. Ambulatory glucose profile data were collected during a 15-day run-in period (baseline), two weeks after automatic mode activation, and every 3 months. The influence of covariates on glycemic outcomes after 1 year of Minimed™ 780G use was assessed. Results. After 15 days of automatic mode use, all glucose metrics improved compared to baseline (p<0.001), except for time below range and coefficient of variation (p=0.113 and p=0.330, respectively). After one year, time in range (TIR) remained significantly higher than at baseline (75.3% vs 62.8%, p<0.001). The mean glycated hemoglobin over the study duration was lower than the previous year (6.9 ± 0.6% vs 7.4 ± 0.9%, p<0.001). Time spent in tight range (70-140 mg/dl) was 51.1% and glycemia risk index was 27.6. Higher TIR levels were associated with a reduced number of automatic correction boluses (p<0.001), fewer SmartGuard exits (p=0.021), and longer time in automatic mode (p=0.030). Individuals with baseline HbA1c > 8% showed more relevant improvement in TIR levels (from 54.3% to 72.3%). Conclusions. Our study highlights the sustained effectiveness of Minimed™ 780G among youths with T1D. Findings suggest that even children and adolescents with low therapeutic engagement may benefit from SmartGuard technology.

Glycated hemoglobin

10.2337/figshare.25505368

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Sustained Effectiveness of an Advanced Hybrid Closed-Loop System in a Cohort of Children and Adolescents With Type 1 Diabetes: A 1-Year Real-World Study

Diabetes Care (2024)

Stefano Passanisi Giuseppina Salzano Bruno Bombaci Nicola Minuto Marta Bassi

OBJECTIVE To investigate glucose metrics and identify potential predictors of the achievement of glycemic outcomes in children and adolescents during their first 12 months of MiniMed 780G use. RESEARCH DESIGN AND METHODS This multicenter, longitudinal, real-world study recruited 368 children and adolescents with type 1 diabetes (T1D) starting SmartGuard technology between June 2020 and June 2022. Ambulatory glucose profile data were collected during a 15-day run-in period (baseline), 2 weeks after automatic mode activation, and every 3 months. The influence of covariates on glycemic outcomes after 1 year of MiniMed 780G use was assessed. RESULTS After 15 days of automatic mode use, all glucose metrics improved compared with baseline (P < 0.001), except for time below range (P = 0.113) and coefficient of variation (P = 0.330). After 1 year, time in range (TIR) remained significantly higher than at baseline (75.3% vs. 62.8%, P < 0.001). The mean glycated hemoglobin (HbA1c) over the study duration was lower than the previous year (6.9 ± 0.6% vs. 7.4 ± 0.9%, P < 0.001). Time spent in tight range (70–140 mg/dL) was 51.1%, and the glycemia risk index was 27.6. Higher TIR levels were associated with a reduced number of automatic correction boluses (P < 0.001), fewer SmartGuard exits (P = 0.021), and longer time in automatic mode (P = 0.030). Individuals with baseline HbA1c >8% showed more relevant improvement in TIR levels (from 54.3% to 72.3%). CONCLUSIONS Our study highlights the sustained effectiveness of MiniMed 780G among youth with T1D. Findings suggest that even children and adolescents with low therapeutic engagement may benefit from SmartGuard technology.

10.2337/dc23-2311

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Sustained effectiveness of an advanced hybrid closed loop system in a cohort of children and adolescents with type 1 diabetes: a one-year real-world study

Stefano Passanisi Giuseppina Salzano Bruno Bombaci Nicola Minuto Marta Bassi

Glycated hemoglobin

10.2337/figshare.25505368.v1

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From pediatric to adult care: a survey on the transition process in type 1 diabetes mellitus and the diabetes services in Italy

Acta Diabetologica (2024)

Vanna Graziani Tosca Suprani Paolo Di Bartolo Federico Marchetti Maurizio Bonati

Adult care

10.1007/s00592-024-02268-3

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Author response for "Retrospective analysis of 24‐month real‐world glucose control for children and adolescents with type 1 diabetes using the MiniMed TM 670G insulin pump"

Maurizio Delvecchio Alessio Galati Claudio Maffeis Stefano Passanisi Riccardo Bonfanti

Insulin delivery

10.1111/dom.14934/v2/response1

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Type 1 diabetes onset in Lombardy region, Italy, during the COVID-19 pandemic: The double-wave occurrence

EClinicalMedicine (2021)

Chiara Mameli Andrea Scaramuzza Maddalena Macedoni Giuseppe Marano Giulio Frontino

Diabetic ketoacidosis

Pandemic

10.1016/j.eclinm.2021.101067

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Citations (43)

A retrospective analysis of 24‐month real‐world glucose control for children and adolescents with type 1 diabetes using the MiniMed™ 670G insulin pump

Diabetes Obesity and Metabolism (2022)

Maurizio Delvecchio Alessio Galati Claudio Maffeis Stefano Passanisi Riccardo Bonfanti

The peer review history for this article is available at https://publons.com/publon/10.1111/dom.14934. Data available on request due to privacy/ethical restrictions Appendix S1. Supporting Information. Table S1. Results of the correlation analysis. %CGM, proportion of time when the continuous glucose monitoring worked; TIR, time in range; GRI, glycaemia risk index; SG, sensor glucose; %CV, glycaemic variability; %HCL, proportion of time when the hybrid closed loop was enabled; TDD, total daily dose. Level of significance: * P ≤ 0.001; # P ≤ 0.01; ° P < 0.05 Table S2. Results of the forward stepwise multivariate regression analysis. TIR, time in range; %CGM, proportion of time when the continuous glucose monitoring worked; %HCL, proportion of time when the hybrid closed loop was enabled; TDD, total daily dose; GRI, glycaemia risk index. Figure S1. The upper part displays the boxplot HbA1c during the 24-month study. The lower part displays the percentage of patients with time spent with sensor glucose below 70 mg/dL (TBR) < 4%, within 70 and 180 mg/dL (TIR) > 70%, and above 180 mg/dL (TAR) < 25% at each timepoint of the study. Figure S2. Rate of basal and premeal insulin during the study. The TDD was 0.91 ± 0.26 IU/kg/d at baseline, 0.90 ± 0.24 IU/kg/d at 6 months, 0.90 ± 0.20 IU/kg/d at 12 months, 0.90 ± 0.22 IU/kg/d at 18 months, and 0.90 ± 0.22 IU/kg/d at 24 months. No statistical differences were found. Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.

Insulin pump

Insulin delivery

10.1111/dom.14934

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Author response for "Retrospective analysis of 24‐month real‐world glucose control for children and adolescents with type 1 diabetes using the MiniMed TM 670G insulin pump"

Maurizio Delvecchio Alessio Galati Claudio Maffeis Stefano Passanisi Riccardo Bonfanti

Insulin delivery

10.1111/dom.14934/v3/response1

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