Real-world evaluation of safety and efficacy of AHCL systems in young children with type 1 diabetes: a 1-year assessment
Background and aimsManagement of Type 1 Diabetes (T1D) in young children is challenging. A poor glycaemic control during the first years of disease increases the risk of microvascular complications. Moreover, hyperglycaemia and glucose variability have a negative effect on the brain development. Adv...
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Frontiers Media S.A.
2025-06-01
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| Series: | Frontiers in Endocrinology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fendo.2025.1590964/full |
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| author | Daniele Franzone Giordano Spacco Andrea Piano Giulia Siri Giacomo Tantari Giuseppe d’Annunzio Maria Grazia Calevo Mohamad Maghnie Mohamad Maghnie Nicola Minuto Marta Bassi Marta Bassi |
| author_facet | Daniele Franzone Giordano Spacco Andrea Piano Giulia Siri Giacomo Tantari Giuseppe d’Annunzio Maria Grazia Calevo Mohamad Maghnie Mohamad Maghnie Nicola Minuto Marta Bassi Marta Bassi |
| author_sort | Daniele Franzone |
| collection | DOAJ |
| description | Background and aimsManagement of Type 1 Diabetes (T1D) in young children is challenging. A poor glycaemic control during the first years of disease increases the risk of microvascular complications. Moreover, hyperglycaemia and glucose variability have a negative effect on the brain development. Advanced hybrid closed loop (AHCL) systems demonstrated to improve glycaemic control in adolescents and adults with T1D although data on younger children are limited. The aim of the study was to evaluate the safety and the effectiveness of AHCL systems’ off-label use in children aged less than 7 years.MethodsA retrospective single-center study on T1D patients aged less than 7 years using AHCL systems was conducted. Glycated hemoglobin (HbA1c) values, Continuous Glucose Monitoring (CGM) and insulin requirement data were collected at T0 (AHCL starting), T1 (1-month), T2 (3-months) and T3 (1-year).Results41 patients were included in the study. No episode of severe hypoglycaemia occurred. Three patients experienced an episode of ketoacidosis (DKA) due to insulin delivery set occlusion. During the 12-months study period, an improvement in HbA1c value (7.50 vs 6.59%, p<0.001), Time in Range (TIR, +10.21%, p<0.001) and Time in Tight Range (TITR, +7.56%, p=0.003) were observed, with a reduction in time in hyperglycaemia and without an increase in time in hypoglycaemia. The AHCL use increased insulin requirement at 12-months, especially in bolus doses (p<0.001).ConclusionsAlthough AHCL systems are not currently approved for this age group, we have demonstrated their safety and efficacy in children under 7 years with T1D. The use of these systems resulted in significant improvement in glycaemic control without increasing the risk of hypoglycaemia. The impact of early glycaemic control on brain development during the first years of life may support the early introduction of AHCL systems in very young children with T1D. It is essential to gather data that could support the approval of these systems for use in younger age groups. |
| format | Article |
| id | doaj-art-ec844d91d875425887d68a475e8ec7a5 |
| institution | Kabale University |
| issn | 1664-2392 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Endocrinology |
| spelling | doaj-art-ec844d91d875425887d68a475e8ec7a52025-08-20T03:27:52ZengFrontiers Media S.A.Frontiers in Endocrinology1664-23922025-06-011610.3389/fendo.2025.15909641590964Real-world evaluation of safety and efficacy of AHCL systems in young children with type 1 diabetes: a 1-year assessmentDaniele Franzone0Giordano Spacco1Andrea Piano2Giulia Siri3Giacomo Tantari4Giuseppe d’Annunzio5Maria Grazia Calevo6Mohamad Maghnie7Mohamad Maghnie8Nicola Minuto9Marta Bassi10Marta Bassi11DINOGMI (Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health), University of Genoa, Genoa, ItalyDINOGMI (Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health), University of Genoa, Genoa, ItalyDINOGMI (Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health), University of Genoa, Genoa, ItalyDepartment of Pediatrics and Neonatology, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Giannina Gaslini, Savona, ItalyPediatric Clinic, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Giannina Gaslini, Genoa, ItalyPediatric Clinic, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Giannina Gaslini, Genoa, ItalyBiostatistics Unit, Scientific Directorate, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Giannina Gaslini, Genoa, ItalyDINOGMI (Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health), University of Genoa, Genoa, ItalyPediatric Clinic, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Giannina Gaslini, Genoa, ItalyDepartment of Pediatrics and Neonatology, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Giannina Gaslini, Savona, ItalyDINOGMI (Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health), University of Genoa, Genoa, ItalyPediatric Clinic, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Giannina Gaslini, Genoa, ItalyBackground and aimsManagement of Type 1 Diabetes (T1D) in young children is challenging. A poor glycaemic control during the first years of disease increases the risk of microvascular complications. Moreover, hyperglycaemia and glucose variability have a negative effect on the brain development. Advanced hybrid closed loop (AHCL) systems demonstrated to improve glycaemic control in adolescents and adults with T1D although data on younger children are limited. The aim of the study was to evaluate the safety and the effectiveness of AHCL systems’ off-label use in children aged less than 7 years.MethodsA retrospective single-center study on T1D patients aged less than 7 years using AHCL systems was conducted. Glycated hemoglobin (HbA1c) values, Continuous Glucose Monitoring (CGM) and insulin requirement data were collected at T0 (AHCL starting), T1 (1-month), T2 (3-months) and T3 (1-year).Results41 patients were included in the study. No episode of severe hypoglycaemia occurred. Three patients experienced an episode of ketoacidosis (DKA) due to insulin delivery set occlusion. During the 12-months study period, an improvement in HbA1c value (7.50 vs 6.59%, p<0.001), Time in Range (TIR, +10.21%, p<0.001) and Time in Tight Range (TITR, +7.56%, p=0.003) were observed, with a reduction in time in hyperglycaemia and without an increase in time in hypoglycaemia. The AHCL use increased insulin requirement at 12-months, especially in bolus doses (p<0.001).ConclusionsAlthough AHCL systems are not currently approved for this age group, we have demonstrated their safety and efficacy in children under 7 years with T1D. The use of these systems resulted in significant improvement in glycaemic control without increasing the risk of hypoglycaemia. The impact of early glycaemic control on brain development during the first years of life may support the early introduction of AHCL systems in very young children with T1D. It is essential to gather data that could support the approval of these systems for use in younger age groups.https://www.frontiersin.org/articles/10.3389/fendo.2025.1590964/fulltype 1 diabetestoddlersAID (automated insulin delivery)AHCL (advanced hybrid closed loop)off-label |
| spellingShingle | Daniele Franzone Giordano Spacco Andrea Piano Giulia Siri Giacomo Tantari Giuseppe d’Annunzio Maria Grazia Calevo Mohamad Maghnie Mohamad Maghnie Nicola Minuto Marta Bassi Marta Bassi Real-world evaluation of safety and efficacy of AHCL systems in young children with type 1 diabetes: a 1-year assessment Frontiers in Endocrinology type 1 diabetes toddlers AID (automated insulin delivery) AHCL (advanced hybrid closed loop) off-label |
| title | Real-world evaluation of safety and efficacy of AHCL systems in young children with type 1 diabetes: a 1-year assessment |
| title_full | Real-world evaluation of safety and efficacy of AHCL systems in young children with type 1 diabetes: a 1-year assessment |
| title_fullStr | Real-world evaluation of safety and efficacy of AHCL systems in young children with type 1 diabetes: a 1-year assessment |
| title_full_unstemmed | Real-world evaluation of safety and efficacy of AHCL systems in young children with type 1 diabetes: a 1-year assessment |
| title_short | Real-world evaluation of safety and efficacy of AHCL systems in young children with type 1 diabetes: a 1-year assessment |
| title_sort | real world evaluation of safety and efficacy of ahcl systems in young children with type 1 diabetes a 1 year assessment |
| topic | type 1 diabetes toddlers AID (automated insulin delivery) AHCL (advanced hybrid closed loop) off-label |
| url | https://www.frontiersin.org/articles/10.3389/fendo.2025.1590964/full |
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