Efficacy and Safety of Tubeless Hybrid Closed-Loop Systems in Type 1 Diabetes: A Meta-Analysis of Randomized Controlled Trials
Abstract
Objective: To evaluate the efficacy and safety of tubeless hybrid closed-loop (HCL) systems in type 1 diabetes (T1D).
Methods: We searched Web of Science, PubMed, Scopus, and Embase from inception to April 1st, 2026 for randomized controlled trials (RCTs) comparing tubeless HCL systems with standard care (SC; sensor-augmented pumps [SAP] or multiple daily injections [MDI] + continuous glucose monitoring [CGM]). Primary efficacy outcomes were time in range of 3.9-10.0 mmol/L (TIR) and glycated haemoglobin (HbA1c). Secondary efficacy outcomes included time above range (TAR10.0, TAR13.9), time below range (TBR3.9, TBR3.0), and coefficient of variability (CV). Safety outcomes included severe hypoglycaemia (SH) and diabetic ketoacidosis (DKA) risks. Random- or fixed-effects models were used as appropriate.
Results: Four RCTs involving 514 participants were included. The mean age was 32.3 ± 15.7 years, with a mean T1D duration of 14.7 ± 11.1 years, and with mean baseline HbA1c 8.0% ± 1.0%. Three studies compared tubeless HCL with SAP, and one with MDI + CGM. Compared with SC, tubeless HCL improved TIR (MD = 15.31%, 95% CI [7.67%, 22.95%], I 2 = 95%, p 2 = 91%, p = 0.005). Lower levels of TAR (TAR10.0, TAR13.9), TBR3.9 and CV were also observed (all p 2 = 71%, p = 0.35) and insulin dose. DKA and SH events were rare in both groups.
Conclusions: The available evidence suggests that tubeless HCL systems may improve glycaemic control without increasing insulin dose or short-term safety…
How strong is the evidence?
Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 514 participants or records.
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