Abstract
Abstract Disclosure: A. Godoi: None. I.R. Marques: None. A. Mahesh: None. C. Oommen: None. E.M. Padrao: None. V.C. Moreira: None. A.C. Silva: None. L.C. Hespanhol: None. C.H. Silva: None. I.A. Souza: None. C. Gomes: None. I.A. Miyawaki: None. J.E. Loyola Júnior: None. J. De Sa: None. Background: Optimal glycemic control of Type 1 Diabetes Mellitus (T1DM) remains a clinical challenge instigated by hypoglycemic episodes and the burden of insulin self-management. Remarkable advancements have been made with the development of automated insulin devices, particularly closed-loop systems (CL). Yet, previous meta-analyses have not focused on the long-term use and effects of CL systems, and their potential to improve glycemic outcomes in this population remain controversial. Purpose: To compare the therapeutic efficacy of long-term use of CL insulin delivery systems to standard care (SC) in adult patients with T1DM. Methods: PubMed, Cochrane and EMBASE were systematically searched in October 2022 to include randomized controlled studies (RCTs) comparing CL systems (automated pancreas, hybrid CL and advanced hybrid CL) versus SC (daily insulin injections, sensor augmented pump and continuous glucose monitoring) with at least 12 weeks of duration. Outcomes assessed were percentage time in range (% TIR) 70-180mg/dL and change in HbA1c. Statistical analysis was performed with RevMan 5.4.1 and R software. Heterogeneity was assessed with I² statistics. The protocol was registered in PROSPERO (ID: CRD42022366710). Results: A total of 13 randomized studies with 1082 patients with T1DM were included, of whom 586 (54.2%) used automated devices and 496 (45.8%) continued their usual care. The %TIR was higher in the CL systems when compared to SC (MD 11.91%; 95% CI 8.66 to 15.17; p < 0.001; I² = 81%). The HbA1c significantly higher in the CL systems when compared to SC (MD -0.42; 95% CI -0.70 to -0.14; p = 0.003; I² = 78%). The %TIR was significantly higher in patients using CL (MD 9.25; 95% CI 6.79–11.72; p < 0.0001; I² = 34%), hybrid CL (MD 8.20; 95% CI 3.32–13.09; p=0.001; I² = 66%) and advanced hybrid CL (MD 25.38; 95% CI 21.30–29.46; p < 0.0001; I² = 0%). A greater decrease in HbA1c was also found with the use of CL (MD -0.24; 95% CI -0.47 to -0.010.14; p = 0.04; I² = 0%), hybrid CL (MD -0.26; 95% CI -0.43 to -0.10; p=0.002; I² = 3%) and advanced hybrid CL (MD -0.90; 95% CI -1.86 to -0.06; p = 0.07; I² = 83%). Conclusion: In this meta-analysis of randomized trials, the use of CL insulin delivery systems was associated with a higher proportion of time in the optimal glucose range and greater decrease of HbA1c relative to standard care in the adult diabetic population. Presentation: Saturday, June 17, 2023
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