DBLG1混合闭环系统优化对1型糖尿病血糖指标12个月评估
本研究前瞻性分析2014例使用新版本DBLG1混合闭环系统的欧洲成人1型糖尿病患者，随访最长12个月。主要终点为70–180 mg/dL目标范围内时间（TIR），中位TIR在M3至M12维持在71.7%–72.3%。结果显示该系统12个月内持续安全有效，每日声明≥3餐者TIR显著高于声明<1餐者。
要点
- DBLG1新版本软件12个月内中位TIR维持在71.7%–72.3%，超过70%。
- 每日声明≥3餐者TIR为73.3%，显著高于声明<1餐者的65.7%（p<0.0001）。
- 血糖<54 mg/dL时间占比0.2%、<70 mg/dL占比1.2%和>250 mg/dL占比5.4%，M3至M12保持稳定。
核心结论
- 最新版DBLG1软件在2014例使用者中12个月内持续安全有效，TIR全程超过70%。
- 减少餐次声明会对血糖控制产生负面影响，但软件在此情况下仍保持安全性和可接受的疗效。
研究设计与样本
- 前瞻性分析欧洲使用新版本DBLG1联合Kaleido贴片泵的成人1型糖尿病患者的CGM数据。
- 纳入2014例使用者，年龄42.5±13.8岁，基线HbA1c为7.6%±1.2%。
- 纳入期7个月，随访最长12个月，主要终点为TIR 70–180 mg/dL。
主要发现
- 中位TIR在M3、M6、M9和M12分别为72.0%、72.3%、72.0%和71.7%。
- M3时血糖<54 mg/dL时间占比为0.2%，<70 mg/dL为1.2%，>250 mg/dL为5.4%，并稳定持续至M12。
- 葡萄糖管理指标（GMI）维持在7.0%–7.1%，严重低血糖和高血糖发生率保持很低。
- 每日声明≥3餐者TIR为73.3%（67.3–78.7）%，声明<1餐者TIR为65.7%（60.7–72.2）%，p<0.0001。
关键数值与推荐
- 主要终点：TIR 70–180 mg/dL，中位值M3至M12为71.7%–72.3%。
- 低血糖指标：血糖<54 mg/dL时间占比0.2%，<70 mg/dL时间占比1.2%。
- 高血糖指标：血糖>250 mg/dL时间占比5.4%。
- GMI：7.0%–7.1%。
- TIR比较：每日声明≥3餐组73.3%（67.3–78.7）%对比<1餐组65.7%（60.7–72.2）%，p<0.0001。
临床怎么用
- DBLG1混合闭环系统新版本可用于成人1型糖尿病长期管理，预期TIR可维持在70%以上。
- 鼓励患者每日规范声明餐次，建议每日≥3餐次声明以优化TIR。
- 即使餐次声明减少，系统仍能维持低血糖和严重高血糖风险在较低水平。
以上解读依据论文摘要（全文未开放获取或许可不允许翻译转载）。
原文
ABSTRACT Background The meal period is critical for the outcome of automated insulin delivery. Our aim was to explore the long-term impact on glucose metrics of algorithmic modifications of the DBLG1 hybrid closed-loop system, with special emphasis on the meal declaration pattern. Methods We prospectively analysed CGM data from consenting adult patients with Type 1 diabetes across Europe who initiated the new version of DBLG1 paired with the Kaleido patch pump upon its release. Inclusion occurred over 7 months, with follow-up extended up to 12 months. Time in range 70–180 mg/dL (TIR) was the primary endpoint. Utility endpoints included the number of declared meals. Results This study included 2014 users, age 42.5 ± 13.8 years, baseline HbA1c 7.6% ± 1.2%. Median TIR was 72.0%, 72.3%, 72.0% and 71.7% at M3, M6, M9 and M12, respectively. At M3, time < 54 mg/dL (0.2%), < 70 mg/dL (1.2%) and > 250 mg/dL (5.4%) were controlled and remained stable throughout M12, as well as GMI (7.0%–7.1%). The incidence rates of severe hypo- or hyperglycaemia remained very low. TIR in patients declaring ≥ 3 meals/day exceeded TIR in those declaring < 1 meal/day (73.3 [67.3, 78.7]% vs. 65.7 [60.7, 72.2]%, p < 0.0001). Conclusion This study demonstrates the sustained safety and effectiveness of the latest version of the DBLG1 software, with TIR exceeding 70% throughout the 12-month follow-up period in a large group of 2014 users. Furthermore, while glycaemic control was negatively affected when meal declaration was reduced, the software maintained its safety and acceptable effectiveness in this latter situation.
引用
- Diabetes, Obesity and Metabolism：Impact of DBLG1 Hybrid Closed‐Loop Software Optimization and Meal Declaration Pattern on Glucose Metrics in Type 1 Diabetes: A 12‐Month Prospective Evaluation in 2014 Users
供执业医师工作参考，不替代临床判断；数值与分级以指南原文为准。