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

Abstract

Abstract 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-analysis of randomized trials, fear of hypoglycemia was significantly lower with the use of CL devices compared to UC. However, the groups did not significantly differ when assessing patient reported outcomes of treatment satisfaction and distress. Presentation: Saturday, June 17, 2023