OBJECTIVES: Type 1 diabetes mellitus (T1DM) requires continuous glucose monitoring and intensive insulin therapy. Artificial pancreas (AP) may offer ideal treatment option improving quality of life (QoL) and minimizing safety risks. This systematic review assessed the real-world evidence on the safety and QoL of AP systems in the management of T1DM.

METHODS: A systematic review adhering to PRISMA guidelines was conducted in Embase^® and PubMed^® to identify literature published from January 2018 until May 2023. Real-world studies reporting safety and QoL of various AP systems for T1DM management were included.

RESULTS: A total of 2,020 records were retrieved from Embase^® and PubMed^®. After deduplication, 1,713 publications were reviewed by screening titles and abstracts, followed by full-text screening of 174 publications which finally led to the inclusion of 55 unique publications. Almost half (47.2%) of these were published in the year 2022. Highest proportion (20.6%) of the studies were conducted in the United States and retrospective observational study design was the most (43.6%) adopted amongst all study designs. Advanced hybrid closed loop (34.5%) and hybrid closed loop (29.1%) were the most evaluated AP systems in the included evidence. A total of 37 (74%) studies reported safety-related data, of which 48.6% reported adverse events (AEs)/complications and the remaining 51.4% reported absence of AEs. Severe hypoglycemia (50%) was the most frequently reported AE followed by diabetic ketoacidosis (33.3%). Twenty-two publications utilized surveys and questionnaires to collect the QoL data, of which all except one reported improvement in the QoL. The most frequently used QoL tools were psychosocial variables including Hypoglycemia Fear Survey (36.3%), and Problem Areas in Diabetes (18.1%).

CONCLUSIONS: Real-world evidence identified from our review indicated that the AP systems improved QoL, thereby reducing the burden of T1DM. However, there is a need for further evaluation of the safety aspects of the AP systems.