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 (HbA_1c), 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 HbA_1c 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.

Funding

Dexcom.

中文翻译：

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比较成人 1 型糖尿病的实时和间歇扫描连续血糖监测 (ALERTT1)：一项为期 6 个月的前瞻性、多中心、随机对照试验

背景

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]）或实时监测（实时连续血糖监测 [rtCGM]）。但是，尚不清楚从 isCGM 切换到具有警报功能的 rtCGM 是否会带来额外的好处。因此，我们进行了一项比较 rtCGM 和 isCGM 在成人 1 型糖尿病 (ALERTT1) 中的试验。

方法

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 型糖尿病成人被随机分配（1:1）至 rtCGM（干预）或 isCGM（对照）。根据研究中心、年龄、性别、糖化血红蛋白 (HbA _1c )、范围内的时间（传感器葡萄糖 3·9-10·0 mmol/L）、胰岛素给药方法和低血糖意识，使用最小化集中进行随机化。参与者、研究人员和研究团队没有被掩盖到分组分配中。主要终点是在意向治疗样本中评估的 6 个月后范围内的平均组间差异。该试验已在 ClinicalTrials.gov 注册，NCT03772600。

发现

在 2019 年 1 月 29 日至 7 月 30 日期间，招募了 269 名参与者，其中 254 人被随机分配到 rtCGM（n=127）或 isCGM（n=127）；分别有 124 名和 122 名参与者完成了这项研究。6 个月后，rtCGM 的范围内时间高于 isCGM（59·6% vs 51·9%；平均差 6·85 个百分点 [95% CI 4·36–9·34]；p<0·0001 ）。6 个月后，HbA _1c较低（7·1% vs 7·4%；p<0·0001），时间 <3·0 mmol/L（0·47% vs 0·84%；p=0· 0070）和低血糖恐惧调查第二版担心子量表得分（15·4 vs 18·0；p=0·0071）。更少的 rtCGM 参与者出现严重低血糖（n=3 vsn=13；p=0·0082)。使用 isCGM 时更频繁地观察到皮肤反应，而 rtCGM 用户更频繁地报告传感器插入后出血。

解释

在未选择的成人 1 型糖尿病人群中，在治疗 6 个月后，从 isCGM 转换为 rtCGM 显着改善了范围内的时间，这意味着临床医生应考虑使用 rtCGM 而不是 isCGM 来改善 1 型糖尿病患者的健康和生活质量。

资金

德克斯康。