Division of Pediatric Endocrinology, Diabetes & Metabolism, Nemours Children's Health, Jacksonville, Florida, USA.
Beta Bionics, Concord, Massachusetts, USA.
Diabetes Technol Ther. 2023 Jun;25(6):437-441. doi: 10.1089/dia.2022.0461. Epub 2023 Mar 22.
The bionic pancreas (BP) is initialized with body weight only and doses insulin autonomously without carbohydrate counting, instead using qualitative meal announcements. In case of device malfunction, the BP generates and continuously updates backup insulin doses for injection or pump users, including long-acting insulin dose, a four-period basal insulin profile, short-acting meal doses, and a glucose correction factor. Following a 13-week trial in type 1 diabetes, participants using the BP (6-83 years) completed 2-4 days, in which they were randomly assigned to their prestudy insulin regimen ( = 147) or to follow BP-provided guidance ( = 148). Glycemic outcomes with BP guidance were similar to those reinstituting their prestudy insulin regimen, with both groups having higher mean glucose and lower time-in-range than while using the BP during the 13-week trial. In conclusion, a backup insulin regimen automatically generated by the BP can be safely implemented if need arises to discontinue use of the BP. Clinical Trial Registry: linicaltrials.gov; NCT04200313.
仿生胰腺（BP）仅通过体重初始化，无需计算碳水化合物即可自主给予胰岛素，而是使用定性的进餐通知。如果设备发生故障，BP 将为注射或泵使用者生成并持续更新备用胰岛素剂量，包括长效胰岛素剂量、四段基础胰岛素轮廓、短效进餐剂量和葡萄糖校正因子。在为期 13 周的 1 型糖尿病试验中，使用 BP 的参与者（6-83 岁）完成了 2-4 天的试验，在此期间，他们被随机分配到他们的预研究胰岛素方案（ = 147）或遵循 BP 提供的指导（ = 148）。使用 BP 指导的血糖结果与恢复使用预研究胰岛素方案的结果相似，两组的平均血糖均高于使用 BP 进行 13 周试验时，而时间达标率则低于使用 BP 时。总之，如果需要停止使用 BP，可以安全地实施由 BP 自动生成的备用胰岛素方案。临床试验注册号：linicaltrials.gov；NCT04200313。
