Efficacy and safety of closed-loop insulin delivery versus sensor-augmented pump in the treatment of adults with type 1 diabetes: a systematic review and meta-analysis of randomized-controlled trials.

ABSTRACT

BACKGROUND: Controversy remains regarding whether closed-loop (CL) insulin delivery or insulin sensor-augmented pump (SAP) delivery is more efficient for clinical treatment. Therefore, we aimed to compare the efficacy and safety of CL insulin delivery systems versus insulin SAP delivery for adults with type 1 diabetes (T1D). METHODS: Embase, Ovid MEDLINE, PubMed, ScienceDirect, Scopus, the Cochrane Library, and other databases were searched for related articles, and we analyzed the average blood glucose (BG), time in range (TIR), and adverse effects (AEs) as primary endpoints to evaluate efficacy and safety. RESULTS: Of 1616 articles, 12 randomized-controlled trials (RCTs) were included in the final analysis. Regarding BG control efficacy, CL insulin delivery resulted better outcomes than SAP therapy with regard to the average BG value, which was detected and recorded by continuous glucose monitoring (mean difference [MD][mmol/L]  - 0.25 95% confidence interval [CI]  - 0.42 to - 0.08, p = 0.003); TIR 3.9-10 mmol/L (MD [%] 7.91 95% CI 4.45-11.37, p < 0.00001). Similar results were observed for the secondary outcomes including low blood glucose index (LBGI) (MD  - 0.41 95% CI - 0.55 to - 0.26, p < 0.00001), high blood glucose index (HBGI) (MD  - 2.56 95% CI - 3.38 to - 1.74, p < 0.00001), and standard deviation (SD) of glucose variability (MD [mmol/L] -0.25 95% CI - 0.44 to - 0.06, p = 0.01). Furthermore, SAP therapy was associated with more adverse effects (risk ratio 0.20 95% CI 0.07-0.52, p = 0.001) than CL insulin delivery, and one of the most common adverse effects was hypoglycemia. CONCLUSIONS: CL insulin delivery appears to be a better treatment method than SAP therapy for adults with T1D because of its increased BG control efficacy and decreased number of hypoglycemic events.