Chico Ana, Navas de Solís Sol, Lainez María, Rius Ferran, Cuesta Martín
Department of Endocrinology and Nutrition, Hospital Santa Creu i Sant Pau, Barcelona, Spain.
CIBER-BBN, Instituto de Salud Carlos III, Madrid, Spain.
Diabetes Technol Ther. 2023 Apr;25(4):242-249. doi: 10.1089/dia.2022.0449. Epub 2023 Feb 17.
To evaluate the efficacy, safety and satisfaction of the closed-loop system Accu-Chek Insight with Diabeloop™ (DBLG1™) in adults with type 1 diabetes (T1D) in real-world conditions. Patients with T1D using DBLG1 for at least 3 months were included. Glucometric parameters were analyzed at baseline, 1, 2, and 3 months after starting DBLG1. HbA was measured before and at 3 months. Technical issues and acute complications were recorded and patients completed a satisfaction questionnaire. Sixty-two patients were included (43 women; age 44.2 ± 11 years; diabetes duration 24.6 ± 12 years; 40 used flash and 22 continuous glucose monitoring (CGM); 45 were on insulin pump and 17 on multiple daily injections). A significant improvement was observed in the CGM-derived glucose metrics early in the first month: Time in range (%TIR) 70-180 mg/dL (54.86 ± 17 vs. 72.23 ± 10.11); time above range level 1 (%TAR1) 180-250 mg/dL (26.26 ± 13.3 vs. 19.48 ± 6.78), time above range level 2 (%TAR2) > 250 mg/dL (12.02 ± 13.09 vs. 6.14 ± 5.23), time below range level 1 (%TBR 1) 54-70 mg/dL (5.73 ± 11.5 vs. 1.67 ± 1.3), time below range level 2 (%TBR2) < 54 mg/dL (1.18 ± 1.97 vs.0.44 ± 0.49), %CV (38.66 ± 7.53 vs. 29.63 ± 3.74), median glucose (168.57 ± 36 mg/dL vs. 154.63 ± 17.55 mg/dL), and %GMI (7.37 ± 0.91 vs. 7.02 ± 0.42). Also, HbA decreased significantly (7.45% ± 1.05% vs. 6.95% ± 0.7%). No acute complications or serious adverse events occurred. Similar improvement was observed regardless of prior therapy or the glucose monitoring system used. Three patients discontinued DBLG1 and 21 experienced technical issues. Overall, patient satisfaction was high. Adjustments of the settings were modified in general in the direction of greater aggressiveness. A significant improvement in glycemic control without serious adverse events and a high degree of patient satisfaction were observed in this first real-world study evaluating the closed-loop system, Accu-Chek Insight with Diabeloop.
评估在实际临床环境中，闭环系统Accu-Chek Insight与Diabeloop™（DBLG1™）对1型糖尿病（T1D）成人患者的疗效、安全性及满意度。纳入使用DBLG1至少3个月的T1D患者。在开始使用DBLG1前及之后的1、2、3个月分析血糖参数。在使用前及3个月时测量糖化血红蛋白（HbA）。记录技术问题及急性并发症，患者完成满意度调查问卷。共纳入62例患者（43例女性；年龄44.2±11岁；糖尿病病程24.6±12年；40例使用实时动态血糖监测，22例使用持续葡萄糖监测（CGM）；45例使用胰岛素泵，17例每日多次注射胰岛素）。在第一个月早期，CGM衍生的血糖指标有显著改善：血糖在目标范围内时间（%TIR）70 - 180mg/dL（54.86±17对72.23±10.11）；高于目标范围水平1时间（%TAR1）180 - 250mg/dL（2,6.26±13.3对,19.48±6.78），高于目标范围水平2时间（%TAR2）>250mg/dL（12.02±13.09对6.14±5.23），低于目标范围水平1时间（%TBR 1）54 - 70mg/dL（5.73±11.5对1.67±1.3），低于目标范围水平2时间（%TBR2）<54mg/dL（1.18±1.97对0.44±0.49），血糖变异系数（%CV）（38.66±7.53对29.63±3.74），平均血糖（168.57±36mg/dL对154.63±17.55mg/dL），及糖化血红蛋白估算值（%GMI）（7.37±0.91对7.02±0.42）。此外，HbA显著下降（7.45%±1.05%对6.95%±0.7%）。未发生急性并发症或严重不良事件。无论先前治疗方案或所使用的血糖监测系统如何，均观察到类似改善。3例患者停用DBLG且21例出现技术问题。总体而言，患者满意度较高。一般而言，设置调整朝着更积极的方向进行。在这项评估闭环系统Accu-Chek Insight与Diabeloop的首次实际临床研究中，观察到血糖控制显著改善，无严重不良事件，且患者满意度较高。
