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

Author:

Passanisi Stefano1ORCID,Salzano Giuseppina1,Bombaci Bruno1,Minuto Nicola2,Bassi Marta23,Bonfanti Riccardo4,Scialabba Francesco4,Mozzillo Enza5,Di Candia Francesca5,Monti Sara6,Graziani Vanna7,Maffeis Claudio8,Piona Claudia Anita8,Arnaldi Claudia9,Tosini Davide9,Felappi Barbara10,Roppolo Rosalia11,Zanfardino Angela12,Delvecchio Maurizio13,Lo Presti Donatella14,Calzi Elena15,Ripoli Carlo16,Franceschi Roberto17,Reinstadler Petra18,Rabbone Ivana19,Maltoni Giulio20,Alibrandi Angela21,Zucchini Stefano22,Marigliano Marco8,Lombardo Fortunato1, ,Grosso Caterina,Cherubini Valentino,Tiberi Valentina,Piccinno Elvira,Zecchino Clara,Prandi Elena,Ricciardi Maria Rossella,Stamati Filomena,Costanza Giuseppe,Pezzino Giulia,Rosaria De Marco,Bratta Anna,Spacco Giordano,Rigamonti Andrea,Frontino Giulio,Predieri Barbara,Iafusco Dario,Rosanio Francesco,Pozzi Erica,Cardella Francesca,Dal Bo Sara,Riso Chiara

Affiliation:

1. 1Department of Human Pathology in Adult and Developmental Age “Gaetano Barresi,” University of Messina, Messina, Italy

2. 2Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Giannina Gaslini, Genoa, Italy

3. 3Department of Neurosciences, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa, Genoa, Italy

4. 4Pediatric Diabetology Unit, Department of Pediatrics, Diabetes Research Institute, IRCCS San Raffaele Scientific Institute, Vita Salute San Raffaele University, Milan, Italy

5. 5Section of Pediatrics, Department of Translational Medical Science, Regional Center of Pediatric Diabetes, Federico II University of Naples, Naples, Italy

6. 6Pediatrics Unit, Department of Woman’s and Child and Adolescent Health, Azienda Unità Sanitaria Locale (AUSL) Romagna, Bufalini Hospital, Cesena, Italy

7. 7Pediatrics Unit, Department of Woman’s and Child and Adolescent Health, AUSL Romagna, S. Maria delle Croci Hospital, Ravenna Italy

8. 8Pediatric Diabetes and Metabolic Disorders Unit, Regional Center for Pediatric Diabetes, University City Hospital, Verona, Italy

9. 9Unitá Operativa Semplice Diabetologia Pediatrica ASL Viterbo, Viterbo, Italy

10. 10U.S. Auxoendocrinologia Pediatrica, Unitá Operativa Complessa Pediatria-Clinica Pediatrica, Azienda Socio Sanitaria Territoriale (ASST) Spedali Civili, Brescia, Italy

11. 11Unitá Operativa Semplice Dipartimentale Diabetologia Pediatrica, Dipartimento di Pediatria, Ospedale dei Bambini, Palermo, Italia

12. 12Department of Pediatrics, Regional Center of Pediatric Diabetology “G.Stoppoloni,” University of Campania “Luigi Vanvitelli,” Naples, Italy

13. 13Department of Biotechnological and Applied Clinical Sciences (DISCAB), University of L’Aquila, L’Aquila, Italy

14. 14Regional Referral Centre of Pediatric Diabetes, University Hospital “Policlinico,” Catania, Italy

15. 15Department of Pedatrics and Neonatology, ASST Crema Hospital, Crema, Italy

16. 16Pediatric Diabetology Unit, Department of Pediatrics, ASL 8 Cagliari, Cagliari, Italy

17. 17Department of Pediatrics, S. Chiara Hospital of Trento, Azienda Provinciale per i Servizi Sanitari, Trento, Italy

18. 18Ospedale di Bolzano - Azienda Sanitaria dell’Alto Adige, Bolzano, Italy

19. 19Division of Pediatrics, Department of Health Sciences, University of Piemonte Orientale, Novara, Italy

20. 20Pediatric Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy

21. 21Unit of Statistical and Mathematical Sciences, Department of Economics, University of Messina, Messina, Italy

22. 22Azienda Ospedaliera-Universitaria di Ferrara, Ferrara, Italy

Abstract

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.

Publisher

American Diabetes Association

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