SAT-613 Continuous Subcutaneous Insulin Infusion Versus Multiple Daily Injections For Glycemic Control In Pediatric Patients With Type 1 Diabetes: A Systematic Review, Meta-analysis, And Trial Sequential Analysis

Abstract Disclosure: E. Calderon Martinez: None. S. Zachariah Saji: None. M. Sámano Sánchez: None. M. Nieto: None. A. Hammoud: None. E. De la Rosa-Valdez: None. G.D. Briceno Silva: None. V.S. Arruarana: None. A. Newman Molina: None. C. Sanchez Cruz: None. J. Noreña Velasquez: None. R. Correa Marquez: None. C. Sierra Cogollos: None. Introduction: Type 1 diabetes mellitus (T1DM) is a chronic autoimmune disease requiring lifelong insulin therapy. In pediatric populations, the two primary delivery modalities—multiple daily injections (MDI) and continuous subcutaneous insulin infusion (CSII)—have been widely adopted. However, the comparative efficacy and safety of these approaches remain debated. This systematic review and meta-analysis aimed to evaluate glycemic control and other metabolic and safety outcomes between CSII and MDI in children and adolescents with T1DM. Methods: This review followed PRISMA guidelines and was prospectively registered in PROSPERO (CRD420250653042). A systematic search was conducted in PubMed MEDLINE, Web of Science, Scopus, EMBASE, Cochrane CENTRAL, CINAHL, and China National Knowledge Infrastructure (CNKI) from inception to February 2025. We included randomized controlled trials (RCTs) comparing CSII and MDI in pediatric patients (≤21 years) with T1DM. Primary outcomes were glycated hemoglobin (HbA1c) and insulin dose. Secondary outcomes included body mass index (BMI), severe hypoglycemia, diabetic ketoacidosis (DKA), and adverse events. Meta-analyses used random-effects models, and heterogeneity was assessed using I². Trial Sequential Analysis (TSA) was performed only for the primary outcome. Results: A total of 18 randomized controlled trials encompassing 1,229 pediatric participants were included. Meta-analysis of HbA1c levels demonstrated a statistically significant reduction favoring CSII over MDI (MD = -0.37%; 95% CI: -0.62 to -0.12; p = 0.004; I2 = 89.3%). TSA for HbA1c indicated that the accrued sample size did not reach the required information size (RIS = 122,246), and the cumulative Z-curve did not cross the conventional or trial sequential monitoring boundaries. For total insulin dose, pooled analysis yielded a non-significant difference (MD = -0.08 U/kg/day; 95% CI: -0.19 to 0.03; p = 0.15; I2 = 93.3%). TSA for insulin dose estimated an RIS of 2,601 participants. The cumulative Z-curve crossed the conventional significance threshold but did not reach the trial sequential monitoring boundary. Secondary outcomes did not demonstrate statistically significant differences between CSII and MDI: BMI (MD = 0.18; 95% CI: -0.33 to 0.69; p = 0.49; I2 = 95.7%), severe hypoglycemia (risk ratio [RR] = 1.09; 95% CI: 0.66 to 1.81; p = 0.74; I2 = 0%), DKA (RR = 1.40; 95% CI: 0.61 to 3.21; p = 0.43; I2 = 0%), and adverse events (RR = 1.45; 95% CI: 0.95 to 2.19; p = 0.08; I2 = 45.8%). Conclusion: CSII may offer modest benefits over MDI in glycemic control, but TSA findings indicate current evidence is insufficient for firm conclusions. No clear advantages were observed in secondary outcomes. Further large-scale, well-designed RCTs are needed to confirm these findings, particularly regarding long-term clinical outcomes in pediatric T1DM management. Presentation: Saturday, July 12, 2025