Glycometabolic outcomes in adult type 1 diabetic patients switching to closed-loop systems

Abstract

Objective: This study aimed to evaluate glycometabolic outcomes in AID technology-naïve T1D patients after switching to Hybrid Closed Loop (HCL) and Advanced Hybrid Closed Loop (AHCL) systems.

Research design and methods: This was a 12-month, prospective, observational, two-center study on 54 type 1 diabetes (T1D) patients aged 19-65 years managed with multiple daily injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII) in open-loop to evaluate the superiority in terms of effectiveness and safety of Automated Insulin Delivery (AID) systems.

Results: HbA1c levels significantly improved at the end of the study. Time spent with glucose levels in target range (TIR_{70-180 mg/dL, 3.9-10 mmol/L}) increased from 50.5 ± 15.6% at baseline to 73.6 ± 8.0% at 12 months (p < 0.001); time spent above range (TAR_{180-250 mg/dL, 10-13.9 mmol/L} and TAR_{≥250 mg/dL, 13.9 mmol/L}) decreased from 30.6 ± 9.0% and 14.2 ± 10.2 at baseline to 19.3 ± 5.3% and 4.8 ± 3.3% at 12 months (p < 0.001 for both), respectively; time spent below range (TBR_{54-69 mg/dL, 3-3.8 mmol/L} and TBR_{<54 mg/dL, 3.0 mmol/L}) decreased from 3.5 ± 2.6% and 1.2 ± 1.4% at baseline to 1.9 ± 1.5% and 0.4 ± 0.7% at the end of the study (p < 0.001 for both); coefficient of variation (CV) decreased from 35.9 ± 7.8% at baseline to 33.0 ± 5.3% (p < 0.05). Satisfaction with the new technology was scored as high.

Conclusion: AID-naïve T1D patients switching to HCL/AHCL systems have significantly and safely improved their glycometabolic outcomes with their high satisfaction with the new type of treatment.

Keywords: AHCL; Advanced hybrid closed loop; Closed loop systems; HCL; Hybrid closed loop; Type 1 diabetes mellitus.