Efficacy and Safety of iLet Bionic Pancreas in Patients With Type 1 Diabetes Mellitus: A Systematic Review and Meta Analysis.

BACKGROUND: This systematic review and meta-analysis evaluated the efficacy and safety of the iLet bionic pancreas (iLet BP), a novel automated insulin delivery (AID) system, in managing type 1 diabetes. Unlike conventional AID systems, which require user input for insulin dosing, the iLet BP autonomously determines insulin delivery based solely on body weight. The study synthesized data from five randomized controlled trials (RCTs), comprising a total of 1130 patients, comparing iLet BP with standard care (SC). OUTCOMES ASSESSED: Primary outcomes included changes in HbA1c, mean glucose levels, and time in target glucose range (70-180 mg/dL), measured via continuous glucose monitoring (CGM). Secondary outcomes assessed adverse events and hypoglycaemia. KEY FINDINGS: Results demonstrated that the iLet BP significantly improved glycaemic control. The pooled analysis showed a standardised mean difference (SMD) in HbA1c of -0.50 [-0.63, -0.38] and in mean glucose levels of -0.36 [-0.50, -0.21] favouring iLet BP. Time in target glucose range was significantly higher with iLet BP (SMD: 0.58 [0.43, 0.73]). However, the odds of adverse events were notably higher in the iLet BP group (OR: 15.48 [8.07, 29.70]), while the risk of hypoglycaemia (OR: 2.22 [0.83, 5.94]) was not statistically significant. CONCLUSION: In conclusion, the iLet BP shows strong potential in improving glycaemic outcomes in patients with type 1 diabetes. However, concerns remain regarding its safety profile, particularly related to adverse events. Further large-scale, high-quality studies are needed to confirm its effectiveness and ensure broader clinical applicability.