Baliga Bantwal S, Tillman John B, Olson Byron, Vaughan Sarah, Sheikh F Naureen, Malone James K
East Alabama Endocrinology PC, Opelika, AL.
Bigfoot Biomedical, Inc., Milpitas, CA.
Clin Diabetes. 2023 Fall;41(4):539-548. doi: 10.2337/cd22-0126. Epub 2023 Jun 21.
The Bigfoot Unity Diabetes Management System, a smart pen cap system cleared by the U.S. Food and Drug Administration in May 2021, incorporates continuous glucose monitoring data, real-time glycemic alerts, and clinician-directed dose recommendations. This study analyzed real-world clinical outcomes data for an initial cohort ( = 58, from 13 clinics) managing multiple daily injection insulin therapy using the pen cap system for 6 months. We examined glycemic control, including hypoglycemia events and interaction with and use of the pen cap system. In a cohort mainly consisting of adults with type 2 diabetes and an average age of 62 years, the results demonstrate close adherence to established glycemic targets, including a relatively short amount of time spent in the hypoglycemic range.
大脚怪统一糖尿病管理系统是一种智能笔帽系统，于2021年5月获得美国食品药品监督管理局批准，它整合了连续血糖监测数据、实时血糖警报以及临床医生指导的剂量建议。本研究分析了初始队列（来自13家诊所的58名患者）使用该笔帽系统进行每日多次注射胰岛素治疗6个月的真实世界临床结局数据。我们研究了血糖控制情况，包括低血糖事件以及与笔帽系统的交互和使用情况。在一个主要由平均年龄为62岁的2型糖尿病成年人组成的队列中，结果表明患者严格遵守既定的血糖目标，包括在低血糖范围内花费的时间相对较短。
