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一款基础胰岛素剂量管理智能手机应用控制 2 型糖尿病患者空腹血糖的疗效:一项单中心、随机临床试验。

Efficacy of a basal insulin dose management smartphone application for controlling fasting blood glucose in patients with type-2 diabetes mellitus: A single-centre, randomised clinical study.

机构信息

Department of Endocrinology, Binhaiwan Central Hospital of Dongguan, Dongguan, Guangdong Province, China.

Cardiovascular Internal Medicine, Binhaiwan Central Hospital of Dongguan, Dongguan, Guangdong Province, China.

出版信息

Clin Endocrinol (Oxf). 2023 Oct;99(4):361-369. doi: 10.1111/cen.14956. Epub 2023 Aug 1.

Abstract

OBJECTIVE

To explore the efficacy and safety of the 'Walk with you' application for titrating basal insulin (BI) doses in type-2 diabetes mellitus (T2DM) hospitalised patients.

METHODS

This was a randomised, single-centre, open-label, controlled clinical trial to compare the changes in fasting blood glucose (FBG) and postprandial blood glucose (PBG), time to reach target FBG (FBG-TRT), incidence of hypoglycaemia events and FBG coefficient of variation in the application group (weight-based titration of BI dose regimen) and control group (typical adjustment regimen).

PATIENTS

This study selected 173 patients with T2DM using basal-prandial insulin therapy who were admitted to Binhaiwan Central Hospital of Dongguan between December 2021 and December 2022. Patients were randomised to the control group or the application group (App group) and then titrated to achieve an FBG concentration of less than 7.0 mmol/L.

RESULTS

There were 86 patients in the control group and 87 patients in the App group. The FBG concentrations in the control and App groups were decreased by 6.77 ± 4.75 and 5.95 ± 4.06 mmol/L, respectively. The FBG-TRTs in the control and App groups were 3.80 ± 1.52 and 2.82 ± 1.34 days, respectively (p < .001). Fewer patients in the control group reached the FBG-TRT within 3 days than in the App group, with 46.5% and 71.3% of patients reaching that target, respectively. There was no significant between-group difference in hypoglycaemia incidence.

CONCLUSION

The use of this weight-based insulin dose titration protocol for BI app is effective and safe for achieving the target FBG in noncritically ill patients with T2DM and is free, easy to use and user friendly.

摘要

目的

探索“与你同行”应用程序在调整 2 型糖尿病(T2DM)住院患者基础胰岛素(BI)剂量中的疗效和安全性。

方法

这是一项随机、单中心、开放标签、对照临床试验,旨在比较应用组(基于体重的 BI 剂量方案)和对照组(典型调整方案)空腹血糖(FBG)和餐后血糖(PBG)的变化、达到目标 FBG(FBG-TRT)的时间、低血糖事件发生率和 FBG 变异系数。

患者

本研究纳入 2021 年 12 月至 2022 年 12 月在东莞滨海湾中心医院接受基础-餐时胰岛素治疗的 173 例 T2DM 患者。患者被随机分为对照组或应用组(App 组),然后进行滴定以达到 FBG 浓度低于 7.0mmol/L。

结果

对照组和 App 组分别有 86 例和 87 例患者。对照组和 App 组的 FBG 浓度分别降低了 6.77±4.75mmol/L 和 5.95±4.06mmol/L。对照组和 App 组的 FBG-TRT 分别为 3.80±1.52 天和 2.82±1.34 天(p<0.001)。对照组中在 3 天内达到 FBG-TRT 的患者比例低于 App 组,分别为 46.5%和 71.3%。两组低血糖发生率无显著差异。

结论

在非危重症 T2DM 患者中,使用这种基于体重的 BI 剂量滴定方案调整 BI 剂量,能够有效且安全地达到目标 FBG,且免费、易于使用和用户友好。

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