Abstract
The study aimed to evaluate the effectiveness and safety of long-term use of closed-loop insulin system (CLS) in non-pregnant patients with type 1 diabetes mellitus (T1DM) using systematic review and meta-analysis. A literature search was performed using MEDLINE, EMBASE, and the Cochrane Library. Randomized controlled trials (RCTs) on long-term use (not less than 8 weeks) of CLS in patients with T1DM were selected. Meta-analysis was performed with RevMan V.5.3.5 to compare CLS with controls (continuous subcutaneous insulin infusion with blinded continuous glucose monitoring or unblinded sensor-augmented pump therapy or multiple daily injections or predictive low-glucose suspend system) in adults and children with type 1 diabetes. Research quality evaluation was conducted using the Cochrane risk of bias tool. Eleven RCTs (817 patients) that satisfied the eligibility criteria were included in the meta-analysis. Compared with controls, the CLS group had a favorable effect on the proportion of time with sensor glucose level in 3.9-10 mmol/L (10.32%, 8.70% to 11.95%), above 10 mmol/L (-8.89%, -10.57% to -7.22%), or below 3.9 mmol/L (-1.09%, -1.54% to -0.64%) over 24 hours. The CLS group also had lower glycated hemoglobin levels (-0.30%, -0.41% to -0.19%), and glucose variability, coefficient of variation of glucose, and SD were lower by 1.41 (-2.38 to -0.44, p=0.004) and 6.37 mg/dL (-9.19 mg/dL to -3.55 mg/dL, p<0.00001). There were no significant differences between the CLS and the control group in terms of daily insulin dose, quality of life assessment, and satisfaction with diabetes treatment. CLS is a better solution than control treatment in optimizing blood glucose management in patients with T1DM. CLS could become a common means of treating T1DM in clinical practice.