比利时鲁汶大学医院Pieter Gillard团队比较了成人1型糖尿病患者实时和间歇扫描连续血糖监测（ALERTT1）的控糖效果。2021年6月2日，该成果发表在《柳叶刀》杂志上。
1型糖尿病患者可以按需连续监测血糖水平（间歇扫描连续血糖监测[isCGM]），也可以实时监测血糖水平（实时连续血糖监测[rtCGM]）。然而，目前尚不清楚从isCGM切换到具有警报功能的rtCGM是否会带来额外获益。
研究组在比利时的六家医院进行了一项前瞻性、双臂、平行组、多中心、随机对照试验，将先前使用isCGM的1型糖尿病成人按1：1随机分为干预组（rtCGM）和对照组（isCGM）。参与者、研究者和研究小组没有被掩盖分组。主要终点为6个月后在意向治疗样本中评估的组间时间差异的平均值。
2019年1月29日至7月30日，研究组共招募了269名参与者，其中254名被随机分配，每组各127例。rtCGM组124名和isCGM组122名参与者分别完成了这项研究。6个月后，rtCGM组的血糖正常范围的时间比为59.6%，显著高于isCGM组的51.9%；平均HbA1c为7.1%，显著低于isCGM组的7.4%；<3.0 mmol/L的时间占0.47%，显著低于isCGM组的0.84%；低血糖恐惧调查第二版焦虑量表得分为15.4分，显著低于isCGM组的18.0分。rtCGM组中严重低血糖率显著低于isCGM组。isCGM患者更常观察到皮肤反应，rtCGM患者更常报告传感器插入后出血。
研究结果表明，对于未经选择的成人1型糖尿病人群，从isCGM转换到rtCGM，6个月后控糖效果显著改善。
附：英文原文
Title: Comparing real-time and intermittently scanned continuous glucose monitoring in adults with type 1 diabetes (ALERTT1): a 6-month, prospective, multicentre, randomised controlled trial
Author: Margaretha M Visser, Sara Charleer, Steffen Fieuws, Christophe De Block, Robert Hilbrands, Liesbeth Van Huffel, Toon Maes, Gerd Vanhaverbeke, Eveline Dirinck, Nele Myngheer, Chris Vercammen, Frank Nobels, Bart Keymeulen, Chantal Mathieu, Pieter Gillard
Issue&Volume: 2021-06-02
Abstract:
Background
People with type 1 diabetes can continuously monitor their glucose levels on demand (intermittently scanned continuous glucose monitoring [isCGM]), or in real time (real-time continuous glucose monitoring [rtCGM]). However, it is unclear whether switching from isCGM to rtCGM with alert functionality offers additional benefits. Therefore, we did a trial comparing rtCGM and isCGM in adults with type 1 diabetes (ALERTT1).
Methods
We did a prospective, double-arm, parallel-group, multicentre, randomised controlled trial in six hospitals in Belgium. Adults with type 1 diabetes who previously used isCGM were randomly assigned (1:1) to rtCGM (intervention) or isCGM (control). Randomisation was done centrally using minimisation dependent on study centre, age, gender, glycated haemoglobin (HbA1c), time in range (sensor glucose 3·9–10·0 mmol/L), insulin administration method, and hypoglycaemia awareness. Participants, investigators, and study teams were not masked to group allocation. Primary endpoint was mean between-group difference in time in range after 6 months assessed in the intention-to-treat sample. This trial is registered with ClinicalTrials.gov, NCT03772600.
Findings
Between Jan 29 and Jul 30, 2019, 269 participants were recruited, of whom 254 were randomly assigned to rtCGM (n=127) or isCGM (n=127); 124 and 122 participants completed the study, respectively. After 6 months, time in range was higher with rtCGM than with isCGM (59·6% vs 51·9%; mean difference 6·85 percentage points [95% CI 4·36–9·34]; p<0·0001). After 6 months HbA1c was lower (7·1% vs 7·4%; p<0·0001), as was time <3·0 mmol/L (0·47% vs 0·84%; p=0·0070), and Hypoglycaemia Fear Survey version II worry subscale score (15·4 vs 18·0; p=0·0071). Fewer participants on rtCGM experienced severe hypoglycaemia (n=3 vs n=13; p=0·0082). Skin reaction was more frequently observed with isCGM and bleeding after sensor insertion was more frequently reported by rtCGM users.
Interpretation
In an unselected adult type 1 diabetes population, switching from isCGM to rtCGM significantly improved time in range after 6 months of treatment, implying that clinicians should consider rtCGM instead of isCGM to improve the health and quality of life of people with type 1 diabetes.
DOI: 10.1016/S0140-6736(21)00789-3
Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00789-3/fulltext
LANCET：《柳叶刀》，创刊于1823年。隶属于爱思唯尔出版社，最新IF：202.731
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本期文章：《柳叶刀》：Online/在线发表
