OBJECTIVE To evaluate the association of insulin injection adherence, smart insulin pen engagement, and glycemic control using real-world data from 16 countries from adults self-administering basal insulin degludec and bolus insulin with a smart insulin pen (NovoPen 6 or NovoPen Echo Plus) alongside continuous glucose monitoring (CGM). RESEARCH DESIGN AND METHODS Data were aggregated over 14-day periods. Treatment adherence was defined according to the number of missed basal and missed bolus insulin doses and smart pen engagement according to the number of days with data uploads. RESULTS Data from 3,945 adults, including 25,157 14-day periods with ≥70% CGM coverage, were analyzed. On average, 0.2 basal and 6.0 bolus insulin doses were missed over 14 days. The estimated probability of missing at least one basal insulin dose over a 14-day period was 17.6% (95% CI 16.5, 18.7). Missing one basal or bolus insulin dose per 14 days was associated with a significant decrease in percentage of time with glucose levels in range (TIR) (3.9–10.0 mmol/L), of −2.8% (95% CI −3.7, −1.8) and −1.7% (−1.8, −1.6), respectively; therefore, missing two basal or four bolus doses would decrease TIR by >5%. Smart pen engagement was associated positively with glycemic outcomes. CONCLUSIONS This combined analysis of real-world smart pen and CGM data showed that missing two basal or four bolus insulin doses over a 14-day period would be associated with a clinically relevant decrease in TIR. Smart insulin pens provide valuable insights into treatment injection behaviors.

中文翻译：

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在现实环境中使用智能胰岛素笔的糖尿病患者的治疗依从性与连续血糖监测结果之间的关联

目的 使用来自 16 个国家的成年人使用智能胰岛素笔（NovoPen 6 或 NovoPen Echo Plus）自行注射基础德谷胰岛素和推注胰岛素的真实数据，评估胰岛素注射依从性、智能胰岛素笔参与度和血糖控制之间的关联与连续血糖监测 (CGM) 一起使用。研究设计和方法 数据在 14 天的时间内汇总。治疗依从性是根据错过的基础胰岛素剂量和错过的推注胰岛素剂量的数量来定义的，而智能笔的参与度是根据数据上传的天数来定义的。结果 分析了 3,945 名成人的数据，包括 25,157 个 14 天的周期，CGM 覆盖率≥70%。 14 天内平均错过了 0.2 次基础胰岛素剂量和 6.0 次推注胰岛素剂量。 14 天内错过至少一剂基础胰岛素的估计概率为 17.6% (95% CI 16.5, 18.7)。每 14 天错过一剂基础或推注胰岛素剂量与血糖水平处于范围 (TIR) (3.9–10.0 mmol/L) 的时间百分比显着下降相关，达 -2.8% (95% CI -3.7, -1.8) ）和-1.7%（-1.8，-1.6），分别；因此，缺少两次基础剂量或四次推注剂量将使TIR降低＞5％。智能笔的使用与血糖结果呈正相关。结论 对现实世界的智能笔和 CGM 数据的综合分析表明，在 14 天内缺少两次基础胰岛素剂量或四次推注胰岛素剂量将与临床相关的 TIR 降低相关。智能胰岛素笔为治疗注射行为提供了宝贵的见解。