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经 Tandem Basal-Iq 技术远程软件更新后,伴/不伴糖尿病的胰岛素依赖队列患者的低血糖现实世界改善。

Real-World Improvements in Hypoglycemia in an Insulin-Dependent Cohort With Diabetes Mellitus Pre/Post Tandem Basal-Iq Technology Remote Software Update.

机构信息

From (1)Sansum Diabetes Research Institute, Santa Barbara, California.

Tandem Diabetes Care, Information Technology, San Diego, California.

出版信息

Endocr Pract. 2020 Jul;26(7):714-721. doi: 10.4158/EP-2019-0554. Epub 2020 Nov 24.

Abstract

OBJECTIVE

Software updatable insulin pumps, such as the t:slim X2 pump from Tandem Diabetes Care, enable access to new technology as soon as it is commercialized. The remote software update process allows for minimal interruption in therapy compared to purchasing a new pump; however, little quantitative data exist on the software update process or on pre/post therapeutic outcomes. We examined real-world usage and impact of a remote software updatable predictive low-glucose suspend (PLGS) technology designed to reduce hypoglycemic events in people with insulin-dependent diabetes.

METHODS

Approximately 15,000 U.S. Tandem pump users remotely updated their t:slim X2 software to Basal-IQ PLGS technology since its commercial release. We performed a retrospective analysis of users who uploaded at least 21 days of pre/post PLGS update usage data to the Tandem t:connect web application between August 28, 2018, and October 21, 2019 (N = 6,170). Insulin delivery and sensor-glucose values were analyzed per recent international consensus and American Diabetes Association guidelines. Software update performance was also assessed.

RESULTS

Median software update time was 5.36 minutes. Overall glycemic outcomes for pre and post software update showed a decrease in sensor time <70 mg/dL from 2.14 to 1.18% (-1.01; 95% confidence interval [CI], -0.97, -1.05; P<.001), with overall sensor time 70 to 180 mg/dL increasing from 57.8 to 58.5% (0.64; 95% CI, 0.04, 1.24; P<.001). These improvements were sustained at 3, 6, and 9 months after the update.

CONCLUSION

Introduction of a software updatable PLGS algorithm for the Tandem t:slim X2 insulin pump resulted in sustained reductions of hypoglycemia.

ABBREVIATIONS

ADA = American Diabetes Association; CGM = continuous glucose monitoring; CI = confidence interval; PLGS = predictive low-glucose suspend; SG = sensor glucose; T1D = type 1 diabetes; T2D = type 2 diabetes; TIR = time-in-range.

摘要

目的

像泰盟(Tandem Diabetes Care)的 t:slim X2 胰岛素泵这样的软件可升级胰岛素泵,可使患者在新技术商业化后立即使用。与购买新泵相比,远程软件更新过程只需进行最小程度的治疗中断;然而,关于软件更新过程或治疗前后的治疗结果,几乎没有定量数据。我们研究了远程软件可升级预测性低血糖暂停(PLGS)技术的实际使用情况及其对依赖胰岛素的糖尿病患者降低低血糖事件的影响。

方法

自该技术商业化以来,大约有 15000 名美国泰盟胰岛素泵用户远程更新了他们的 t:slim X2 软件以使用 Basal-IQ PLGS 技术。我们对 2018 年 8 月 28 日至 2019 年 10 月 21 日期间至少上传了 21 天 PLGS 更新使用数据的 t:connect 网络应用程序用户(N=6170)进行了回顾性分析。胰岛素输送和传感器血糖值是根据最近的国际共识和美国糖尿病协会的指南进行分析的。还评估了软件更新性能。

结果

中位软件更新时间为 5.36 分钟。软件更新前后的总体血糖结果显示,传感器时间<70mg/dL 的比例从 2.14%下降至 1.18%(-1.01;95%置信区间[CI],-0.97,-1.05;P<.001),传感器时间 70 至 180mg/dL 的比例从 57.8%上升至 58.5%(0.64;95%CI,0.04,1.24;P<.001)。这些改善在更新后 3、6 和 9 个月时持续存在。

结论

泰盟 t:slim X2 胰岛素泵中引入软件可升级 PLGS 算法后,持续降低了低血糖症的发生。

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