Jaeb Center for Health Research Foundation, Inc., Tampa, Florida, USA.
Diabetes Technol Ther. 2022 Jun;24(6):396-402. doi: 10.1089/dia.2021.0548. Epub 2022 Feb 23.
Although insulin pump infusion set failures are common, studies assessing the failure rate are limited. Data were analyzed from two clinical trials, in which 263 participants aged 6-72 years used 22,741 infusion sets. The frequency of removal due to prolonged hyperglycemia (continuous glucose monitor measuring >300 mg/dL immediately before removal and >250 mg/dL continuously for at least 2 h before removal with at least 90 min >300 mg/dL out of the prior 120 min) was determined. Differences in failure rates among age groups and infusion set types were evaluated. Among 22,741 infusion sets, 748 (3.3%) were removed before 72 h in association with prolonged hyperglycemia. The percentage replaced within 48 h and within 24 h with prolonged hyperglycemia were 1.8% and 1.0%, respectively. Mean duration of continuous time >250 mg/dL before removal was 5.1 ± 3.7 h. Using a less restrictive definition of failure related to hyperglycemia, 1688 (7.4%) sets were removed before 72 h with a glucose level >300 mg/dL at the time of removal. The frequency of insulin set failure with prolonged hyperglycemia was lower in adults ≥18 years old (1.9%) than in those 14-17 years old (5.8%, < 0.001) or 6-13 years old (4.4%, = 0.002). The 90° Teflon sets had the highest frequency of prolonged hyperglycemia failure within 72 h (4.0%) compared with the angled Teflon set frequency (1.3%, = 0.01) or the steel set frequency (1.9%, = 0.006). Based on the data from these 22,741 infusion sets, infusion set changes associated with prolonged hyperglycemia occur on average about four times a year, with the frequency being higher in youth than adults. The frequency also appears to be higher with straight Teflon sets compared with angled Teflon sets and steel sets. Clinical Trials Registration Number: NCT03563313.
尽管胰岛素泵输注套件故障很常见，但评估其故障率的研究有限。 对两项临床试验的数据进行了分析，其中 263 名年龄在 6-72 岁的参与者使用了 22741 个输注套件。 确定了因持续高血糖（连续血糖监测仪在移除前立即测量>300mg/dL，并且在移除前至少 2 小时持续测量>250mg/dL，至少 90 分钟>300mg/dL 超过 120 分钟）而移除的频率。 评估了不同年龄组和输注套件类型之间的故障发生率差异。 在 22741 个输注套件中，有 748 个（3.3%）在 72 小时内因持续高血糖而提前移除。在 48 小时内和在与持续高血糖相关的 24 小时内更换的比例分别为 1.8%和 1.0%。 在移除前，持续时间超过 250mg/dL 的平均值为 5.1±3.7 小时。 使用与高血糖相关的更宽松的故障定义，在 72 小时内，有 1688 个（7.4%）套件因移除时血糖水平>300mg/dL 而被移除。在成人（1.9%）中，因持续高血糖而导致胰岛素套件故障的频率低于 14-17 岁（5.8%，<0.001）或 6-13 岁（4.4%，=0.002）。 在 72 小时内，90°特氟隆套件与延长高血糖失败的频率最高（4.0%）相比，角度特氟隆套件的频率为 1.3%（=0.01）或钢套件的频率为 1.9%（=0.006）。 根据这 22741 个输注套件的数据，与持续高血糖相关的输注套件更换平均每年约发生四次，在年轻人中的频率高于成年人。 与角度特氟隆套件和钢套件相比，特氟隆直套件的频率似乎也更高。 临床试验注册号：NCT03563313。
