Dreon Darlene M, Hannon Trevor M, Cross Brett, Carter Brett J, Mercer Nicholas S, Nguyen Jason H, Tran Andy, Melendez Peter A, Morales Nancy, Nelson Jonathan E, Tan Meng H
1 Calibra Medical, a Johnson & Johnson Company, Wayne, PA, USA.
2 LifeScan, LLC, a Johnson & Johnson Company, Wayne, PA, USA.
J Diabetes Sci Technol. 2018 Jul;12(4):817-827. doi: 10.1177/1932296818760633. Epub 2018 Feb 28.
A basal bolus insulin regimen requires multiple daily insulin injections, which might discourage patient adherence. As a potential solution, a mealtime insulin-delivery system-a 3-day wearable bolus-only patch-was designed to manually administer mealtime insulin discreetly by actuating buttons through clothing, without the need for multiple needle sticks.
Extensive functional testing of the patch included dose accuracy (from initial fill of the device to empty), pressure-vacuum leak testing, last-dose lockout and occlusion detection (safety alert features that lock the dosing buttons when no insulin is delivered), assessments of insulin drug stability, toxicological risk (including chemical testing), and system biocompatibility.
Dosing accuracy was 2 units ±10% (with U-100 insulin) over a range of environmental conditions, with ≥95% reliability and confidence. The fluid seal performance and the safety alert features performed with ≥95% reliability and ≥95% confidence. The system met acceptable standards for insulin (U-100 lispro and aspart) stability for its intended 3-day use, in addition to the operational requirements. The toxicological risk assessment and demonstrated biocompatibility suggested that the patch is safe for human use.
Benchtop performance showed that the bolus-only patch is a safe, accurate, and reliable device for mealtime insulin delivery.
基础-餐时胰岛素治疗方案需要每日多次注射胰岛素，这可能会降低患者的依从性。作为一种潜在的解决方案，设计了一种餐时胰岛素给药系统——一种仅用于推注的可穿戴式3天贴片，通过隔着衣物按压按钮来谨慎地手动给予餐时胰岛素，无需多次注射。
对该贴片进行了广泛的功能测试，包括剂量准确性（从装置初始装药到排空）、压力-真空泄漏测试、末次剂量锁定和堵塞检测（当未输送胰岛素时锁定给药按钮的安全警报功能）、胰岛素药物稳定性评估、毒理学风险（包括化学测试）以及系统生物相容性评估。
在一系列环境条件下，剂量准确性为2单位±10%（使用U-100胰岛素），可靠性和置信度≥95%。流体密封性能和安全警报功能的可靠性≥95%，置信度≥95%。该系统除满足操作要求外，还达到了胰岛素（U-100赖脯胰岛素和门冬胰岛素）在预期3天使用期内的稳定性可接受标准。毒理学风险评估和已证明的生物相容性表明该贴片对人体使用是安全的。
台式性能表明，仅用于推注的贴片是一种用于餐时胰岛素给药的安全、准确且可靠的装置。
