SAT101 Patient Reported Outcomes With Closed-loop Insulin Delivery Versus Usual Care For Type 1 Diabetes: A Meta-analysis Of Randomized Controlled Trials

Disclosure: C.H. Silva: None. A. Godoi: None. E. Padrao: None. I. Reis Marques: None. A.C. Silva: None. V.C. Moreira: None. L.C. Hespanhol: None. I.A. Souza: None. C. Gomes: None. C. Oommen: None. I.A. Miyawaki: None. J.E. Loyola Júnior: None. J. De Sa: None. A. Mahesh: None. Background: Increased diabetes-related stress and burden significantly impact the ability of achieving therapeutic targets, the adherence to self-management and the quality of life of type 1 diabetic patients (T1DM). Patient reported outcomes (PRO) are being increasingly recognized for assessing the reasons for early discontinuation and incorporating therapeutic interventions in diabetes. Although the clinical efficacy of closed-loop (CL) insulin delivery patients has been brought to light in recent years, previous meta-analyses have not yet shown the long-term effects on the lived experience and treatment satisfaction of patients. Purpose: To compare quality of life and treatment satisfaction of patients using CL devices with patients continuing UC in the pediatric and adult population of T1DM. Methods: We systematically searched PubMed, Cochrane and EMBASE in October 2022 to include randomized controlled trials (RCTs) reporting PRO and comparing the long-term use (>12 weeks) of CL systems with usual care (UC) in type 1 diabetic children and adults. CL systems included automated pancreas, hybrid CL, and/or advanced hybrid CL. UC consisted of the use of multiple daily injections, sensor augmented pump and/or continuous glucose monitoring. PRO assessed were Diabetes Treatment Satisfaction (DTSQs), Hypoglycemia Fear Survey (HFS-II), and Problem Areas in Diabetes (PAID). Statistical analysis was performed with RevMan 5.4.1. Heterogeneity was assessed with I² statistics and random-risk effect was used if I2 > 50%. The protocol was registered in PROSPERO (ID: CRD42022366710). Results: We included 7 RCTs with a total of 596 patients, 335 (56.2%) in the closed-loop group and 261 (43.8%) in the usual care group. The fear of hypoglycemia was significantly lower with the use of CL systems (MD -4.31; 95% CI -8.43– -0.18; P = 0.04; I² = 0%) compared to UC. No statistically significant differences between groups were found with regards to treatment satisfaction (MD 1.27; 95% CI -2.07–4.61; P = 0.46; I² = 73%) nor in PAID (MD -4.36; 95% CI -10.62–1.89; P = 0.17; I² = 0%). Moreover, asymmetrical distributions were found in all funnel plots, possibly due to publication bias. Conclusion: In this meta-