• 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Journal of Diabetes Science and Technology >A Randomized Controlled, Treat-to-Target Study Evaluating the Efficacy and Safety of Insulin Glargine 300 U/mL (Gla-300) Administered Using Either Device-Supported or Routine Titration in People With Type 2 Diabetes
【24h】

A Randomized Controlled, Treat-to-Target Study Evaluating the Efficacy and Safety of Insulin Glargine 300 U/mL (Gla-300) Administered Using Either Device-Supported or Routine Titration in People With Type 2 Diabetes

机译：一项随机对照，按靶点研究评估2型糖尿病患者使用设备支持或常规滴定管理的300 G / g甘精胰岛素（Gla-300）的疗效和安全性

获取原文
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

Background: The efficacy/safety of device-supported versus routine titration with Gla-300 in type 2 diabetes (T2DM) was evaluated. Method: AUTOMATIX was a 16-week, randomized, open-label, parallel-group, multicenter, noninferiority trial in insulin-treated or insulin-na?ve people with T2DM. The fasting self-monitored plasma glucose (FSMPG) target was 90-130 mg/dL (5.0-7.2 mmol/L). Primary endpoint: proportion of participants achieving target FSMPG at week 16 without severe hypoglycemia. Secondary endpoints included: proportion reaching FSMPG target without confirmed (≤70 mg/dL [≤3.9 mmol/L]) or severe hypoglycemia; time to first achieve FSMPG target; mean FSMPG and HbA1c change (baseline to week 16). Safety endpoints included hypoglycemia and adverse events. Patient-reported outcomes (PROs) were also assessed. Results: Participants were randomized to device-supported (n = 75) or routine titration (n = 76); 17 participants in the device-supported group discontinued device use. Noninferiority was achieved for the primary endpoint (device-supported: 45.9%, routine: 36.8%; weighted difference: 9.04 [95% CI: ?6.75, 24.83]), but not superiority ( P = .262). The proportion reaching FSMPG target range without confirmed (≤70 mg/dL [≤3.9 mmol/L]) or severe hypoglycemia was 34.3% vs 14.5%, respectively. The time at which 50% of the participants achieved the FSMPG target was less in the device-supported than routine titration arm (10 vs 13 weeks). Least squares mean HbA1c reduction, safety profiles, and PROs were similar in both arms. Mean “ease of use” score for the device, assessed by healthcare professionals and participants on a scale of 1-7, was ≥6. Conclusions: Device-supported self-titration had a good safety/efficacy profile, and was noninferior to routine titration and well accepted by diabetes specialists and patients.
机译：背景：评估了在2型糖尿病（T2DM）中使用设备支持的Gla-300进行常规滴定的有效性/安全性。方法：AUTOMATIX是一项为期16周的随机，开放标签，平行组，多中心，非劣效性试验，用于接受胰岛素治疗或未接受过胰岛素治疗的T2DM患者。空腹自我监测血浆葡萄糖（FSMPG）的目标是90-130 mg / dL（5.0-7.2 mmol / L）。主要终点：在第16周没有严重低血糖的情况下达到目标FSMPG的参与者比例。次要终点包括：未证实达到FSMPG目标的比例（≤70 mg / dL [≤3.9mmol / L]）或严重的低血糖;首先达到FSMPG目标的时间;平均FSMPG和HbA1c变化（基线至第16周）。安全终点包括低血糖症和不良事件。还评估了患者报告的结局（PRO）。结果：参与者被随机分为设备支持（n = 75）或常规滴定（n = 76）;设备支持小组中的17名参与者停止使用设备。主要终点达到非劣效性（设备支持率：45.9％，常规值：36.8％;加权差：9.04 [95％CI：？6.75，24.83]），但没有优势（P = .262）。未证实达到FSMPG目标范围（≤70mg / dL [≤3.9mmol / L]）或严重低血糖的比例分别为34.3％和14.5％。在设备支持下，有50％的参与者达到FSMPG目标的时间比常规滴定臂少（10周比13周）。最小二乘表示两组的HbA1c减少，安全性和PRO相似。由医疗保健专业人员和参与者以1-7的等级评估，该设备的平均“易用性”评分≥6。结论：设备支持的自滴定具有良好的安全性/有效性，并且不亚于常规滴定，并被糖尿病专家和患者广泛接受。

著录项

相似文献

  • 外文文献
  • 中文文献
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号