Department of Endocrinology, University Hospitals Leuven-KU Leuven, Leuven, Belgium.
Interuniversity Institute for Biostatistics and Statistical Bioinformatics, KU Leuven and University of Hasselt, Leuven, Belgium.
Lancet. 2021 Jun 12;397(10291):2275-2283. doi: 10.1016/S0140-6736(21)00789-3. Epub 2021 Jun 2.
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).
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 (HbA), 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.
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 HbA 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.
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.
Dexcom.
1 型糖尿病患者可以按需（间歇性扫描连续血糖监测 [isCGM]）或实时（实时连续血糖监测 [rtCGM]）连续监测血糖水平。然而，目前尚不清楚从 isCGM 切换到具有警报功能的 rtCGM 是否会带来额外的益处。因此，我们进行了一项比较 1 型糖尿病成人患者使用 rtCGM 和 isCGM 的试验（ALERTT1）。
我们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。先前使用 isCGM 的 1 型糖尿病成人患者被随机分配（1:1）接受 rtCGM（干预）或 isCGM（对照）。中央随机化依赖于研究中心、年龄、性别、糖化血红蛋白（HbA）、达标时间（传感器葡萄糖 3.9-10.0mmol/L）、胰岛素给药方法和低血糖意识进行最小化。参与者、研究者和研究团队对分组分配不知情。主要终点是在意向治疗样本中评估的 6 个月时的两组之间时间在目标范围内的平均差异。该试验在 ClinicalTrials.gov 注册，NCT03772600。
2019 年 1 月 29 日至 7 月 30 日期间，共招募了 269 名参与者，其中 254 名被随机分配至 rtCGM（n=127）或 isCGM（n=127）；分别有 124 名和 122 名参与者完成了研究。6 个月后，rtCGM 的达标时间高于 isCGM（59.6% vs 51.9%；平均差异 6.85 个百分点[95%CI 4.36-9.34]；p<0.0001）。6 个月后 HbA 更低（7.1% vs 7.4%；p<0.0001），<3.0mmol/L 的时间也更低（0.47% vs 0.84%；p=0.0070），低血糖恐惧调查量表第二版担忧分量表评分也更低（15.4 分 vs 18.0 分；p=0.0071）。rtCGM 组发生严重低血糖的参与者较少（n=3 与 n=13；p=0.0082）。isCGM 组皮肤反应更常见，rtCGM 用户更常报告传感器插入后出血。
在未选择的 1 型糖尿病成年人群中，从 isCGM 切换到 rtCGM 可显著改善治疗 6 个月后的达标时间，这意味着临床医生应考虑使用 rtCGM 代替 isCGM，以改善 1 型糖尿病患者的健康和生活质量。
Dexcom。
