Unit of Metabolic and Endocrine Disease, "Centro Catanese di Medicina e Chirurgia" Clinic, Catania, Italy.
Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy; Glickman Urological & Kidney Institute, Cleveland Clinic Foundation, Cleveland, OH, USA.
Diabetes Res Clin Pract. 2023 Oct;204:110907. doi: 10.1016/j.diabres.2023.110907. Epub 2023 Sep 12.
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.
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.
HbA1c levels significantly improved at the end of the study. Time spent with glucose levels in target range (TIR) increased from 50.5 ± 15.6% at baseline to 73.6 ± 8.0% at 12 months (p < 0.001); time spent above range (TAR and TAR) 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 and TBR) 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.
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.
本研究旨在评估在切换至混合闭环（HCL）和高级混合闭环（AHCL）系统后，AID 技术初治的 1 型糖尿病（T1D）患者的糖代谢结果。
这是一项为期 12 个月的前瞻性、观察性、双中心研究，纳入了 54 名年龄在 19-65 岁之间、接受多次皮下胰岛素注射（MDI）或连续皮下胰岛素输注（CSII）的开放-loop 治疗的 1 型糖尿病患者，旨在评估自动化胰岛素输送（AID）系统在有效性和安全性方面的优势。
研究结束时，HbA1c 水平显著改善。目标范围内时间（TIR）从基线时的 50.5±15.6%增加到 12 个月时的 73.6±8.0%（p<0.001）；高于范围的时间（TAR 和 TAR）从基线时的 30.6±9.0%和 14.2±10.2%分别减少到 12 个月时的 19.3±5.3%和 4.8±3.3%（均 p<0.001）；低于范围的时间（TBR 和 TBR）从基线时的 3.5±2.6%和 1.2±1.4%分别减少到研究结束时的 1.9±1.5%和 0.4±0.7%（均 p<0.001）；变异系数（CV）从基线时的 35.9±7.8%降至 33.0±5.3%（p<0.05）。对新技术的满意度评分较高。
AID 初治的 T1D 患者切换至 HCL/AHCL 系统后，其糖代谢结果得到显著且安全的改善，同时对新治疗方式的满意度较高。
