Real-time continuous glucose monitoring in adults with type 1 diabetes and impaired hypoglycaemia awareness or severe hypoglycaemia treated with multiple daily insulin injections (HypoDE): a multicentre, randomised controlled trial
Real-time continuous glucose monitoring in adults with type 1 diabetes and impaired hypoglycaemia awareness or severe hypoglycaemia treated with multiple daily insulin injections (HypoDE): a multicentre, randomised controlled trial
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DOI：
10.1016/s0140-6736(18)30297-6
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发表时间：
2018-04-07
期刊：
影响因子：
168.9
通讯作者：
Hermanns, Norbert
中科院分区：
文献类型：
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作者：
Heinemann, Lutz;Freckmann, Guido;Hermanns, Norbert
背景实时连续血糖监测（rtCGM）在每日多次胰岛素注射（MDI）治疗的高危1型糖尿病患者中避免低血糖的有效性尚不清楚。我们的目的是确定在这些个体中使用rtCGM是否可以降低低血糖的发生率和严重程度。方法：HypoDE研究是一项为期6个月、多中心、开放标签、平行、随机对照试验，在德国12家糖尿病诊所进行。符合条件的参与者患有1型糖尿病，并且在过去一年中有低血糖意识受损或严重低血糖的病史。所有参与者都戴了28天的蒙面rtCGM系统，然后随机分配到26周的未蒙面rtCGM （Dexcom G5 Mobile系统）或对照组（继续自我监测血糖）。以研究地点作为分层变量，中心进行1:1分配的块随机化。掩盖参与者和研究地点是不可能的。在随访阶段（第22-26周），对照组参与者使用了蒙面rtCGM系统。主要终点是随访期间基线调整的低血糖事件（定义为葡萄糖= 20分钟）的数量。完整的数据集分析包括在基线和随访阶段佩戴rtCGM系统的参与者。意向治疗分析包括所有随机受试者。该试验已在ClinicalTrials.gov注册，编号NCT02671968。在2016年3月4日至2017年1月12日期间，随机分配了149名参与者（对照组n=74， rtCGM组n=75）， 141名参与者完成了随访阶段（对照组n=66， rtCGM组n=75）。rtCGM组每28天低血糖事件的平均次数从10.8次（SD 10.0）降至3.5次（4.7）；对照组参与者的减少可以忽略不计（从14.4[12.4]到13.7[11.6]）。rtCGM组参与者的低血糖事件发生率降低了72%(发病率比0。28 [95% CI 0.20-0.39], p
Background The effectiveness of real-time continuous glucose monitoring (rtCGM) in avoidance of hypoglycaemia among high-risk individuals with type 1 diabetes treated with multiple daily insulin injections (MDI) is unknown. We aimed to ascertain whether the incidence and severity of hypoglycaemia can be reduced through use of rtCGM in these individuals.Methods The HypoDE study was a 6-month, multicentre, open-label, parallel, randomised controlled trial done at 12 diabetes practices in Germany. Eligible participants had type 1 diabetes and a history of impaired hypoglycaemia awareness or severe hypoglycaemia during the previous year. All participants wore a masked rtCGM system for 28 days and were then randomly assigned to 26 weeks of unmasked rtCGM (Dexcom G5 Mobile system) or to the control group (continuing with self-monitoring of blood glucose). Block randomisation with 1:1 allocation was done centrally, with the study site as the stratifying variable. Masking of participants and study sites was not possible. Control participants wore a masked rtCGM system during the follow-up phase (weeks 22-26). The primary outcome was the baseline-adjusted number of hypoglycaemic events (defined as glucose = 20 min) during the follow-up phase. The full dataset analysis comprised participants who wore the rtCGM system during the baseline and follow-up phases. The intention-to-treat analysis comprised all randomised participants. This trial is registered with ClinicalTrials.gov, number NCT02671968.Findings Between March 4, 2016, and Jan 12, 2017, 149 participants were randomly assigned (n=74 to the control group; n=75 to the rtCGM group) and 141 completed the follow-up phase (n=66 in the control group, n=75 in the rtCGM group). The mean number of hypoglycaemic events per 28 days among participants in the rtCGM group was reduced from 10.8 (SD 10.0) to 3.5 (4.7); reductions among control participants were negligible (from 14.4 [12.4] to 13.7 [11.6]). Incidence of hypoglycaemic events decreased by 72% for participants in the rtCGM group (incidence rate ratio 0. 28 [95% CI 0.20-0.39], p