目的:接受胰岛素治疗的1型糖尿病患者的血糖控制通常较差,其特征是显著的波动。本研究旨在分析钠-葡萄糖协同转运蛋白2抑制剂(SGLT2Is)的作用,作为胰岛素的辅助药物,1型糖尿病患者的时间范围(TIR)和血糖变异性,使用连续血糖监测(CGM)。此外,我们检查了哪种SGLT2I与其他类型相比产生了更好的效果。
方法:我们对PubMed进行了全面搜索,EMBASE,Cochrane图书馆,WebofScience,和临床试验注册网站,检索截至2023年2月发表的所有符合条件的随机临床试验(RCT).我们分析了平均TIR,葡萄糖偏移的平均幅度(MAGE),平均每日葡萄糖(MDG),糖尿病酮症酸中毒(DKA),标准偏差(SD),总胰岛素剂量,和严重低血糖评估SGLT2Is的疗效和安全性。还采用了随机效应模型。
结果:本研究包括15项随机对照试验。荟萃分析显示,使用SGLT2Is作为胰岛素的辅助治疗导致TIR显着增加(MD=10.78,95CI=9.33-12.23,I2=42%,P<0.00001)和SD降低(MD=-0.38,95CI=-0.50至-0.26,I2=0%,P<0.00001),MAGE(MD=-0.92,95CI=-1.17至-0.67,I2=19%,P<0.00001),MDG(MD=-1.01,95CI=-1.32至-0.70,I2=48%,P<0.00001),和总胰岛素剂量(MD=-5.81,95CI=-7.81至-3.82,I2=32%,P<0.00001)。严重低血糖发生率无显著增加(RR=1.04,95%CI=0.76-1.43,P=0.80)。然而,SGLT2I治疗与DKA发生率增加相关(RR=2.79,95%CI=1.42-5.48;P=0.003,I2=16%)。此外,基于SGLT2Is类型的亚组分析显示,在大多数结局中,与其他SGLT2Is相比,达格列净可能表现出更高的疗效.
结论:SGLT2Is对改善血糖水平波动具有积极作用。亚组分析表明,达格列净似乎具有更多的优势。然而,适当考虑防止不利影响,尤其是DKA,是最重要的。
背景:ProsperoCRD42023408276.
Patients undergoing insulin-based therapy for type 1 diabetes often experience poor glycemic control characterized by significant fluctuations. This study was undertaken to analyze the effect of sodium-glucose cotransporter 2 inhibitors (SGLT2Is), as an adjunct to insulin, on time in range (TIR) and glycemic variability in patients with type 1 diabetes, using continuous glucose monitoring (CGM). In addition, we examined which type of SGLT2I yielded a superior effect compared to others.
We conducted a comprehensive search of PubMed, EMBASE, the Cochrane Library, Web of Science, and clinical trial registry websites, retrieving all eligible randomized clinical trials (RCTs) published up until February 2023. We analyzed the mean TIR, mean amplitude of glucose excursions (MAGE), mean daily glucose (MDG), diabetic ketoacidosis (DKA), standard deviation (SD), total insulin dose, and severe hypoglycemia to evaluate the efficacy and safety of SGLT2Is. A random-effects model was also employed.
This study encompassed 15 RCTs. The meta-analysis revealed that the use of SGLT2Is as an adjuvant therapy to insulin led to a significant increase in TIR (MD = 10.78, 95%CI = 9.33-12.23, I2 = 42 %, P < 0.00001) and a decrease in SD (MD = -0.38, 95%CI = -0.50 to -0.26, I2 = 0 %, P < 0.00001), MAGE (MD = -0.92, 95%CI = -1.17 to -0.67, I2 = 19 %, P < 0.00001), MDG(MD = -1.01, 95%CI = -1.32 to -0.70, I2 = 48 %, P < 0.00001), and total insulin dose (MD = -5.81, 95%CI = -7.81 to -3.82, I2 = 32 %, P < 0.00001). No significant increase was observed in the rate of severe hypoglycemia (RR = 1.04, 95 % CI = 0.76-1.43, P = 0.80). However, SGLT2I therapy was associated with increased DKA occurrence (RR = 2.79, 95 % CI = 1.42-5.48; P = 0.003, I2 = 16 %). In addition, the subgroup analyses based on the type of SGLT2Is revealed that dapagliflozin might exhibit greater efficacy compared to other SGLT2Is across most outcomes.
SGLT2Is exhibited a positive effect on improving blood glucose level fluctuations. Subgroup analysis showed that dapagliflozin appeared to have more advantages. However, giving due consideration to preventing adverse effects, particularly DKA, is paramount.
Prospero CRD42023408276.