REVIEW PAPER
EFFECTIVENESS OF HYBRID CLOSED-LOOP SYSTEMS IN PEDIATRIC TYPE 1 DIABETES MELLITUS MANAGEMENT: A SYSTEMATIC REVIEW
1
Public Health School, Centre of Postgraduate Medical Education, Warsaw, Poland
Submission date: 2025-03-04
Final revision date: 2025-04-29
Acceptance date: 2025-05-09
Publication date: 2025-05-19
Corresponding author
Kuba Sękowski
Kuba Sękowski, Public Health School, Centre of Postgraduate Medical Education, Marymoncka 99/103, 01-813 Warsaw, Poland
Kuba Sękowski, Public Health School, Centre of Postgraduate Medical Education, Marymoncka 99/103, 01-813 Warsaw, Poland
KEYWORDS
artificial pancreasinsulin infusion systemsblood glucose self-monitoringtype 1 diabetes mellituspediatrics
TOPICS
ABSTRACT
This systematic review synthesizes findings from 45 studies (2019-2024) on hybrid closed-loop (HCL) systems in pediatric type 1 diabetes (T1D). Consistent improvements in glycemic control were observed, with time-in-range (TIR, 70-180 mg/dL) increasing by 6.7-36.7 percentage points, particularly among patients transitioning from multiple daily injections. Adolescents benefited more than younger children (18.4% vs. 14.3% TIR increase, p=0.01), with nighttime control improving significantly (23.6% TIR increase, p<0.001). HbA1c reductions reached clinical significance in 68% of studies, and the likelihood of achieving HbA1c ≤6.5% tripled with HCL use (OR=3.03, p<0.001). Hyperglycemia (>250 mg/dL) decreased by up to 81%, while hypoglycemia (<70 mg/dL) showed modest but consistent reductions. Preliminary neurodevelopmental findings indicated improved brain structure metrics. However, disparities persist: only 30% of studies included underrepresented groups, and real-world data showed 21% lower HCL adoption in low-income populations. Device efficacy depended on usage patterns, with optimal TIR requiring ≥85% engagement in automated mode. Despite their transformative potential, HCL systems face challenges related to access and variability in response. Future research should focus on long-term outcomes, standardized metrics, and AI-driven personalization to enhance pediatric diabetes management.
REFERENCES (61)
1.
Lan YY, Kovinthapillai R, Kędzia A, Niechciał E. Age-based challenges to type 1 diabetes management in the pediatric population. Front Pediatr. 2024; 12: 1434276. https://doi:10.3389/fped.2024.....
2.
Rimon MTI, Hasan MW, Hassan MF, Cesmeci S. Advancements in insulin pumps: a comprehensive exploration of insulin pump systems, technologies, and future directions. Pharmaceutics. 2024; 16(7): 944. https://doi:10.3390/pharmaceut....
3.
Phillip M, Nimri R, Bergenstal RM, Barnard-Kelly K, Danne T, Hovorka R, et al. Consensus recommendations for the use of automated insulin delivery technologies in clinical practice. Endocr Rev. 2023; 44(2): 254-280. https://doi:10.1210/endrev/bna....
4.
American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2009; 32: S62-S67. https://doi:10.2337/dc09-S062.
5.
International Diabetes Federation. IDF Diabetes Atlas (10th ed.). Brussels: International Diabetes Federation; 2021.
6.
Norris JM, Johnson RK, Stene LC. Type 1 diabetes—early life origins and changing epidemiology. The Lancet Diabetes & Endocrinology. 2020; 8(3): 226-238. https://doi.org/10.1016/S2213-....
7.
Chobot A, Polanska J, Deja G, Jarosz-Chobot P. Increasing trend of childhood type 1 diabetes incidence: 20-year nationwide study in Poland. Pediatric Diabetes. 2023; 24(5): 533-541. https://doi.org/10.1111/pedi.1....
8.
Ilonen J, Lempainen J, Veijola R. The heterogeneous pathogenesis of type 1 diabetes mellitus. Nature Reviews Endocrinology. 2019; 15(11): 635-650. https://doi.org/10.1038/s41574....
9.
Sherr JL, Tauschmann M, Battelino T, de Bock M, Forlenza G, Roman R, et al. ISPAD clinical practice consensus guidelines 2018: diabetes technologies. Pediatric Diabetes. 2018; 19(Suppl 27): 302-325. https://doi.org/10.1111/pedi.1....
10.
Šoupal J, Petruželková L, Flekač M, Pelcl T, Matoulek M, Daňková M, et al. Comparison of different treatment modalities for type 1 diabetes, including sensor-augmented insulin regimens, in 52 weeks of follow-up: a COMISAIR study. Diabetes Technology & Therapeutics. 2016; 18(9): 532-538. https://doi.org/10.1089/dia.20....
11.
Boughton CK, Hovorka R. New closed-loop insulin systems. Diabetologia. 2021; 64(5): 1007-1015. https://doi.org/10.1007/s00125....
12.
U.S. Federal Food and Drug Administration. FDA authorizes first interoperable, automated insulin dosing controller designed to allow more choices for patients looking to customize their individual diabetes management device system [Internet]. Silver Spring: FDA; 2019 Dec 13 [access 2025 March 3]. Available from: https://www.fda.gov/news-event....
13.
U.S. Federal Food and Drug Administration. FDA approves automated insulin delivery and monitoring system for use in younger pediatric patients [Internet]. Silver Spring: FDA; 2018 Jun 21 [access 2025 March 3]. Available from: https://www.fda.gov/news-event....
14.
Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021; 372: n71. https://doi:10.1136/bmj.n71.
15.
Sterne JAC, Savović J, Page MJ, Elbers RG, Blencowe NS, Boutron I, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ (Clinical research ed.). 2019; 366: l4898. https://doi.org/10.1136/bmj.l4....
16.
Beck RW, Bergenstal RM, Riddlesworth TD, Kollman C, Li Z, Brown AS, et al. Validation of time in range as an outcome measure for diabetes clinical trials. Diabetes Care. 2019; 42(3): 400-405. https://doi.org/10.2337/dc18-1....
17.
Petrovski G, Al Khalaf F, Campbell J, Day E, Almajaly D, Hussain K, et al. Successful transitioning children and adolescents with type 1 diabetes from multiple daily injections to advanced hybrid closed-loop system in 10 days: a prospective intervention study on MiniMed 780G system. Acta Diabetologica. 2022; 59(5): 743-746. https://doi.org/10.1007/s00592....
18.
Castorani V, Rigamonti A, Frontino G, Morotti E, Sandullo F, Scialabba F, et al. Turning the tides: achieving rapid and safe glucose control in adolescents with suboptimally controlled type 1 diabetes using advanced hybrid closed loop systems. Frontiers in Endocrinology. 2024; 15: 1243565. https://doi.org/10.3389/fendo.....
19.
Sherr JL, Buckingham BA, Forlenza GP, Galderisi A, Ekhlaspour L, Wadwa RP, et al. Safety and performance of the omnipod hybrid closed-loop system in adults, adolescents, and children with type 1 diabetes over 5 days under free-living conditions. Diabetes Technology & Therapeutics. 2020; 22(3): 174-184. https://doi.org/10.1089/dia.20....
20.
Ware J, Boughton CK, Allen JM, Wilinska ME, Tauschmann M, Denvir L, et al. Cambridge hybrid closed-loop algorithm in children and adolescents with type 1 diabetes: a multicentre 6-month randomised controlled trial. The Lancet. Digital health. 2022; 4(4): e245-e255. https://doi.org/10.1016/S2589-....
21.
Delgado AM, Lucas F. The Tandem Control-IQ advanced hybrid system improves glycemic control in children under 18 years of age with type 1 diabetes and night rest in caregivers. Endocrinologia, Diabetes y Nutricion. 2023; 70(Suppl. 3): 27-35. https://doi.org/10.1016/j.endi....
22.
Lendínez-Jurado A, López-Siguero JP, Gómez-Perea A, Ariza-Jiménez AB, Becerra-Paz I, Tapia-Ceballos L, et al. Pediatric type 1 diabetes: is age at onset a determining factor in advanced hybrid closed-loop insulin therapy?. Journal of Clinical Medicine. 2023; 12(21): 6951. https://doi.org/10.3390/jcm122....
23.
Petrovski G, Al Khalaf F, Campbell J, Umer F, Almajaly D, Hamdan M, et al. One-year experience of hybrid closed-loop system in children and adolescents with type 1 diabetes previously treated with multiple daily injections: drivers to successful outcomes. Acta Diabetol. 2021; 58: 207-213. https://doi.org/10.1007/s00592....
24.
Collyns OJ, Meier RA, Betts ZL, Chan DSH, Frampton C, Frewen CM, et al. Improved glycemic outcomes with medtronic minimed advanced hybrid closed-loop delivery: results from a randomized crossover trial comparing automated insulin delivery with predictive low glucose suspend in people with type 1 diabetes. Diabetes Care. 2021; 44(4): 969-975. https://doi.org/10.2337/dc20-2....
25.
Lindkvist EB, Laugesen C, Reenberg AT, Ritschel TKS, Svensson J, Jørgensen JB, et al. Performance of a dual-hormone closed-loop system versus insulin-only closed-loop system in adolescents with type 1 diabetes. A single-blind, randomized, controlled, crossover trial. Frontiers in Endocrinology. 2023; 14: 1073388. https://doi.org/10.3389/fendo.....
26.
Petrovski G, Al Khalaf F, Campbell J, Day E, Almajaly D, Hussain K et al. Glycemic outcomes of advanced hybrid closed loop system in children and adolescents with type 1 diabetes, previously treated with multiple daily injections (MiniMed 780G system in T1D individuals, previously treated with MDI). BMC Endocrine Disorders. 2022; 22(1): 80. https://doi.org/10.1186/s12902....
27.
Petrovski G, Campbell J, Pasha M, Hussain K, Khalifa A, Umer F, et al. Twelve-month follow-up from a randomized controlled trial of simplified meal announcement versus precise carbohydrate counting in adolescents with type 1 diabetes using the MiniMed™ 780G advanced hybrid closed-loop system. Diabetes Technology & Therapeutics. 2024; 26(S3): 76-83. https://doi.org/10.1089/dia.20....
28.
Cherubini V, Rabbone I, Berioli MG, Giorda S, Lo Presti D, Maltoni G, et al. Effectiveness of a closed-loop control system and a virtual educational camp for children and adolescents with type 1 diabetes: a prospective, multicentre, real-life study. Diabetes, Obesity & Metabolism. 2021; 23(11): 2484-2491. https://doi.org/10.1111/dom.14....
29.
Pihoker C, Shulman DI, Forlenza GP, Kaiserman KB, Sherr JL, Thrasher JR, et al. MiniMed AHCL Study Group. Safety and glycemic outcomes during the MiniMedTM advanced hybrid closed-loop system pivotal trial in children and adolescents with type 1 diabetes. Diabetes Technology & Therapeutics. 2023; 25(11): 755-764. https://doi.org/10.1089/dia.20....
30.
Tinti D, Nobili C, Baretta I, Rosso A, Trada M, de Sanctis L. Paediatric type 1 diabetes mellitus: a comparison between multi-injection therapy and advanced hybrid closed-loop pump in the first year after diabetes onset. Diabetes, Obesity & Metabolism. 2024; 26(9): 4100-4104. https://doi.org/10.1111/dom.15....
31.
Cherubini V, Fargalli A, Arnaldi C, Bassi M, Bonfanti R, Patrizia Bracciolini G, et al. Glucometrics and device satisfaction in children and adolescents with type 1 diabetes using different treatment modalities: a multicenter real-world observational study. Diabetes Research and Clinical Practice. 2024; 210: 111621. https://doi.org/10.1016/j.diab....
32.
Ware J, Allen JM, Boughton CK, Wilinska ME, Hartnell S, Thankamony A, et al. Randomized trial of closed-loop control in very young children with type 1 diabetes. The New England Journal of Medicine. 2022; 386(3): 209-219. https://doi.org/10.1056/NEJMoa....
33.
Lendínez-Jurado A, Gómez-Perea A, Ariza-Jiménez AB, Tapia-Ceballos L, Becerra-Paz I, Martos-Lirio MF, et al. Impact on glucometric variables and quality of life of the advanced hybrid closed-loop system in pediatric and adolescent type 1 diabetes. Journal of Diabetes. 2023; 15(8): 699-708. https://doi.org/10.1111/1753-0....
34.
Santova A, Plachy L, Neuman V, Pavlikova M, Petruzelkova L, Konecna P, et al. Are all HCL systems the same? long term outcomes of three HCL systems in children with type 1 diabetes: real-life registry-based study. Frontiers in Endocrinology. 2023; 14: 1283181. https://doi.org/10.3389/fendo.....
35.
Breton MD, Kanapka LG, Beck RW, Ekhlaspour L, Forlenza GP, Cengiz E, et al. A randomized trial of closed-loop control in children with type 1 diabetes. The New England Journal of Medicine. 2022; 383(9): 836-845. https://doi.org/10.1056/NEJMoa....
36.
Wadwa RP, Reed ZW, Buckingham BA, DeBoer MD, Ekhlaspour L, Forlenza GP, et al. PEDAP Trial Study Group. Trial of hybrid closed-loop control in young children with type 1 diabetes. The New England Journal of Medicine. 2023; 388(11): 991-1001. https://doi.org/10.1056/NEJMoa....
37.
Gianini A, Suklan J, Skela-Savič B, Klemencic S, Battelino T, Dovc K, et al. Patient reported outcome measures in children and adolescents with type 1 diabetes using advanced hybrid closed loop insulin delivery. Frontiers in Endocrinology. 2022; 13: 967725. https://doi.org/10.3389/fendo.....
38.
Ng SM, Katkat N, Day H, Hubbard R, Quinn M, Finnigan L. Real-world prospective observational single-centre study: hybrid closed loop improves HbA1c, time-in-range and quality of life for children, young people and their carers. Diabetic Medicine: a Journal of the British Diabetic Association. 2022; 39(7): e14863. https://doi.org/10.1111/dme.14....
39.
Reiss AL, Jo B, Arbelaez AM, Tsalikian E, Buckingham B, Weinzimer SA, et al. A pilot randomized trial to examine effects of a hybrid closed-loop insulin delivery system on neurodevelopmental and cognitive outcomes in adolescents with type 1 diabetes. Nature Communications. 2022; 13(1): 4940. https://doi.org/10.1038/s41467....
40.
Ware J, Allen JM, Boughton CK, Cezar A, Hartnell S, Wilinska ME, et al. Hybrid closed-loop with faster insulin aspart compared with standard insulin aspart in very young children with type 1 diabetes: a double-blind, multicenter, randomized, crossover study. Diabetes Technology & Therapeutics. 2023; 25(6): 431-436. https://doi.org/10.1089/dia.20....
41.
Dovc K, Boughton C, Tauschmann M, Thabit H, Bally L, Allen JM, et al. Young children have higher variability of insulin requirements: observations during hybrid closed-loop insulin delivery. Diabetes Care. 2019; 42(7): 1344-1347. https://doi.org/10.2337/dc18-2....
42.
Tauschmann M, Allen JM, Nagl K, Fritsch M, Yong J, Metcalfe E, et al. Home use of day-and-night hybrid closed-loop insulin delivery in very young children: a multicenter, 3-week, randomized trial. Diabetes Care. 2019; 42(4): 594-600. https://doi.org/10.2337/dc18-1....
43.
Berget C, Akturk HK, Messer LH, Vigers T, Pyle L, Snell-Bergeon J, et al. Real-world performance of hybrid closed loop in youth, young adults, adults and older adults with type 1 diabetes: Identifying a clinical target for hybrid closed-loop use. Diabetes, Obesity & Metabolism. 2021; 23(9): 2048-2057. https://doi.org/10.1111/dom.14....
44.
Petruzelkova L, Jiranova P, Soupal J, Kozak M, Plachy L, Neuman V, et al. Pre-school and school-aged children benefit from the switch from a sensor-augmented pump to an AndroidAPS hybrid closed loop: a retrospective analysis. Pediatric Diabetes. 2021; 22(4): 594-604. https://doi.org/10.1111/pedi.1....
45.
Tornese G, Buzzurro F, Carletti C, Faleschini E, Barbi E. Six-month effectiveness of advanced vs. standard hybrid closed-loop system in children and adolescents with type 1 diabetes mellitus. Frontiers in Endocrinology. 2021; 12: 766314. https://doi.org/10.3389/fendo.....
46.
Varimo T, Pulkkinen MA, Hakonen E, Hero M, Miettinen PJ, Tuomaala AK. First year on commercial hybrid closed-loop system-experience on 111 children and adolescents with type 1 diabetes. Pediatric Diabetes. 2021; 22(6): 909-915. https://doi.org/10.1111/pedi.1....
47.
Bombaci B, Passanisi S, Alibrandi A, D'Arrigo G, Patroniti S, Averna S, et al. One-year real-world study on comparison among different continuous subcutaneous insulin infusion devices for the management of pediatric patients with type 1 diabetes: the supremacy of hybrid closed-loop systems. International Journal of Environmental Research and Public Health. 2022; 19(16): 10293. https://doi.org/10.3390/ijerph....
48.
Forlenza GP, Ekhlaspour L, DiMeglio LA, Fox LA, Rodriguez H, Shulman DI, et al. Glycemic outcomes of children 2-6 years of age with type 1 diabetes during the pediatric MiniMed™ 670G system trial. Pediatric Diabetes. 2022; 23(3): 324-329. https://doi.org/10.1111/pedi.1....
49.
Kariyawasam D, Morin C, Casteels K, Le Tallec C, Sfez A, Godot C, et al. Hybrid closed-loop insulin delivery versus sensor-augmented pump therapy in children aged 6-12 years: a randomised, controlled, cross-over, non-inferiority trial. The Lancet. Digital Health. 2022; 4(3): e158-e168. https://doi.org/10.1016/S2589-....
50.
Schiaffini R, Deodati A, Nicoletti MC, Carducci C, Ciampalini P, Lorubbio A, et al. Comparison of two advanced hybrid closed loop in a pediatric population with type 1 diabetes: a real-life observational study. Acta Diabetologica. 2022; 59(7): 959-964. https://doi.org/10.1007/s00592....
51.
Seget S, Jarosz-Chobot P, Ochab A, Polanska J, Rusak E, Witoszek P, et al. Body mass index, basal insulin and glycemic control in children with type 1 diabetes treated with the advanced hybrid closed loop system remain stable – 1-year prospective, observational, two-center study. Frontiers in Endocrinology. 2022; 13: 1036808. https://doi.org/10.3389/fendo.....
52.
Vijayanand S, Stevenson PG, Broad E, Davis EA, Taplin CE, Jones TW, et al. Evaluation of real-life clinical outcomes in Australian youth with type 1 diabetes on hybrid closed-loop therapy: a retrospective study. Journal of Paediatrics and Child Health. 2022; 58(9): 1578-1583. https://doi.org/10.1111/jpc.16....
53.
von dem Berge T, Remus K, Biester S, Reschke F, Klusmeier B, Adolph K, et al. In-home use of a hybrid closed loop achieves time-in-range targets in preschoolers and school children: Results from a randomized, controlled, crossover trial. Diabetes, Obesity & Metabolism. 2022; 24(7): 1319-1327. https://doi.org/10.1111/dom.14....
54.
Cordero TL, Dai Z, Arrieta A, Niu F, Vella M, Shin J, et al. Glycemic outcomes during early use of the MiniMed™ 780G advanced hybrid closed-loop system with Guardian™ 4 Sensor. Diabetes Technology & Therapeutics. 2023; 25(9): 652-658. https://doi.org/10.1089/dia.20....
55.
Coutant R, Bismuth E, Bonnemaison E, Dalla-Vale F, Morinais P, Perrard M, et al. Hybrid closed loop overcomes the impact of missed or suboptimal meal boluses on glucose control in children with type 1 diabetes compared to sensor-augmented pump therapy. Diabetes Technology & Therapeutics. 2023; 25(6): 395-403. https://doi.org/10.1089/dia.20....
56.
Elbarbary NS, Ismail EAR. MiniMed 780G™ advanced hybrid closed-loop system performance in Egyptian patients with type 1 diabetes across different age groups: evidence from real-world users. Diabetology & Metabolic Syndrome; 2023; 15(1): 205. https://doi.org/10.1186/s13098....
57.
Piccini B, Felicioni M, Pessina B, Bertini M, Casalini E, Ceccotti C, et al. Glycemic control, basal/bolus distribution, BMI and Meal management in children and adolescents with type 1 diabetes and advanced hybrid closed loop. Nutrients. 2023; 15(23): 4875. https://doi.org/10.3390/nu1523....
58.
Tornese G, Carletti C, Lanzetta MA, Tamaro G, Barbi E, Faleschini E. Safety of real-life usage of advanced hybrid closed-loop system MiniMed 780G in children with type 1 diabetes younger than 7 years old. Diabetes Care. 2023; 46(6): e123-e125. https://doi.org/10.2337/dc22-2....
59.
Martin-Payo R, Fernandez-Alvarez MDM, García-García R, Pérez-Varela Á, Surendran S, Riaño-Galán I. Effectiveness of a hybrid closed-loop system for children and adolescents with type 1 diabetes during physical exercise: a cross-sectional study in real life. Anales de Pediatria. 2024; 101(3): 183-189. https://doi.org/10.1016/j.anpe....
60.
Seget S, Chobot A, Tarasiewicz M, Bielawska A, Rusak E, Ochab A, et al. Glycemic control in children with type 1 diabetes treated with the advanced hybrid closed loop system 2-year prospective, observational, two-center study. Frontiers in Endocrinology. 2024; 15: 1332418. https://doi.org/10.3389/fendo.....
61.
Rapini N, Martino M, Arnaldi C, Deodati A, Anagnostopoulou L, Amodeo ME, et al. Efficacy and safety of advanced hybrid closed loop systems in children with type 1 diabetes younger than 6 years. Frontiers in Endocrinology. 2024; 15: 1382920. https://doi.org/10.3389/fendo.....
| eISSN: | 2354-0265 |
| ISSN: | 2353-6942 |
We process personal data collected when visiting the website. The function of obtaining information about users and their behavior is carried out by voluntarily entered information in forms and saving cookies in end devices. Data, including cookies, are used to provide services, improve the user experience and to analyze the traffic in accordance with the Privacy policy. Data are also collected and processed by Google Analytics tool (more).
You can change cookies settings in your browser. Restricted use of cookies in the browser configuration may affect some functionalities of the website.
You can change cookies settings in your browser. Restricted use of cookies in the browser configuration may affect some functionalities of the website.
