First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu 807-8555, Japan.
Endocr J. 2021 Mar 28;68(3):361-369. doi: 10.1507/endocrj.EJ20-0577. Epub 2020 Nov 18.
The present study used intermittently scanned continuous glucose monitoring (isCGM) in 10 patients with type 1 diabetes mellitus (T1DM) to evaluate the efficacy and safety of 7-day outpatient treatment with the combination of intensive insulin therapy and sodium-glucose transporter 2 inhibitor (SGLT2-I). All participants wore isCGM and were treated with either 50 mg/day ipragliflozin or 5 mg/day dapagliflozin. The primary outcome, percent time with glucose at 70-180 mg/dL (TIR: time in range), improved significantly following the addition of SGLT2-I (p = 0.005). TIR increased from 36.0% before addition of SGLT2-I to 70.7% on day 7. Although none of the patients achieved TIR of 70% or higher before the addition of SGLT2-I, 6 patients met that criteria TIR on day 7. The secondary outcome measures, standard deviation (SD) of glucose, average plasma glucose, percent time with glucose at >180 mg/dL (TAR: time above range), maximum plasma glucose, high blood glucose index (HBGI) and average nocturnal plasma glucose (midnight to 05:59 AM) detected by isCGM, also improved significantly by SGLT2-I. There were no significant differences in percent time with glucose at <70 mg/dL (TBR: time below range), minimum plasma glucose and low blood glucose index (LBGI). Our results using isCGM in an actual clinical setting showed that 7-day use of SGLT2-I with intensive insulin therapy improved plasma glucose fluctuations and mean plasma glucose levels without inducing hypoglycemia in patients with T1DM.
本研究使用间歇性扫描连续血糖监测(isCGM)对 10 例 1 型糖尿病(T1DM)患者进行了评估,以评估强化胰岛素治疗联合钠-葡萄糖转运蛋白 2 抑制剂(SGLT2-I)的 7 天门诊治疗的疗效和安全性。所有参与者均佩戴 isCGM,并接受 50mg/天伊格列净或 5mg/天达格列净治疗。主要结局指标,即葡萄糖在 70-180mg/dL 范围内的时间百分比(TIR:时间在范围内),在添加 SGLT2-I 后显著改善(p=0.005)。TIR 从添加 SGLT2-I 前的 36.0%增加到第 7 天的 70.7%。虽然在添加 SGLT2-I 之前没有患者达到 TIR 70%或更高,但有 6 名患者在第 7 天达到了这一 TIR 标准。次要结局指标,即葡萄糖标准差(SD)、平均血浆葡萄糖、葡萄糖>180mg/dL 的时间百分比(TAR:时间超过范围)、最大血浆葡萄糖、高血糖指数(HBGI)和通过 isCGM 检测的平均夜间血浆葡萄糖(午夜至 05:59 AM),也被 SGLT2-I 显著改善。葡萄糖<70mg/dL 的时间百分比(TBR:时间低于范围)、最小血浆葡萄糖和低血糖指数(LBGI)无显著差异。我们在实际临床环境中使用 isCGM 的结果表明,在 T1DM 患者中,7 天使用 SGLT2-I 联合强化胰岛素治疗可改善血糖波动和平均血浆葡萄糖水平,而不会引起低血糖。