Department of Endocrinology, Grenoble University Hospital, Grenoble Alpes University, INSERM U1055, LBFA, Grenoble, France.
Diabeloop SA, Paris, France.
Diabetes Obes Metab. 2023 Jun;25(6):1607-1613. doi: 10.1111/dom.15008. Epub 2023 Feb 21.
The Diabeloop Generation 1 (DBLG1) system is an interoperable hybrid closed-loop solution that was commercialized in Germany in March 2021. We report the longitudinal glycaemic outcomes among the first 3706 users in a real-world setting.
We performed a retrospective data collection of all consenting adult patients with type 1 diabetes who were equipped in Germany with the DBLG1 system before 30 April 2022, and with a minimum 14 days of closed-loop usage.
In total, 3706 users (41% women, age 45.1 ± 14.5 years) met the inclusion criteria, reaching a mean follow-up of 131.0 ± 85.1 days, an overall 485 600 days of continuous glucose monitoring data, and a median time spent in closed-loop of 95.0% (IQR 89.1-97.4). The median percentage time in range (70-180 mg/dl) was 72.1% (IQR 65.0-78.9); the time below 70 mg/dl was 0.9% (0.5-1.7), the time below 54 mg/dl was 0.1% (0.1-0.3), and the median Glucose Management Index was 7.0% (6.8-7.3). Exploratory analysis of a subset of 2460 patients in whom baseline glycated haemoglobin (HbA1c) was available [7.4% (IQR 6.9-8.0)] showed that the achieved mean time in range was influenced by baseline HbA1c, ranging from 65.8 ± 9.9% (A1c ≥8.5%) to 81.3 ± 6.8% (A1c <6.5%).
This large real-world analysis confirms the relevance of the DBLG1 automated insulin delivery solution for the achievement of standards of care in adult patients with type 1 diabetes.
Diabeloop Generation 1（DBLG1）系统是一种互操作的混合闭环解决方案，于 2021 年 3 月在德国商业化。我们报告了在真实环境中首批 3706 名使用者的纵向血糖结果。
我们对所有同意在德国配备 DBLG1 系统的 1 型糖尿病成年患者进行了回顾性数据收集，这些患者在 2022 年 4 月 30 日前至少使用了 14 天闭环。
共有 3706 名使用者（41%为女性，年龄 45.1±14.5 岁）符合纳入标准，随访时间平均为 131.0±85.1 天，连续血糖监测数据总计 485600 天，闭环时间中位数为 95.0%（IQR 89.1-97.4）。在范围内的时间中位数百分比（70-180mg/dl）为 72.1%（IQR 65.0-78.9）；血糖低于 70mg/dl 的时间为 0.9%（0.5-1.7），血糖低于 54mg/dl 的时间为 0.1%（0.1-0.3），血糖管理指数中位数为 7.0%（6.8-7.3）。对基线糖化血红蛋白（HbA1c）可用的 2460 名患者的亚组进行的探索性分析[7.4%（IQR 6.9-8.0）]表明，达到的范围内平均时间受基线 HbA1c 的影响，范围从 65.8±9.9%（A1c≥8.5%）到 81.3±6.8%（A1c<6.5%）。
这项大型真实世界分析证实了 DBLG1 自动胰岛素输送解决方案在实现 1 型糖尿病成年患者护理标准方面的重要性。
