在现实环境中，Control-IQ技术对1型糖尿病青少年患者报告的结局指标和血糖控制产生积极影响。
Control-IQ Technology Positively Impacts Patient Reported Outcome Measures and Glycemic Control in Youth with Type 1 Diabetes in a Real-World Setting.
作者信息
Zuijdwijk Caroline, Courtney Jennilea, Mitsakakis Nicholas, Hayawi Lamia, Sutherland Stephanie, Newhook Dennis, Ahmet Alexandra, Goldbloom Ellen B, Khatchadourian Karine, Lawrence Sarah
机构信息
Division of Endocrinology and Metabolism, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.
CHEO Research Institute, Ottawa, Ontario, Canada.
出版信息
Pediatr Diabetes. 2023 Apr 12;2023:5106107. doi: 10.1155/2023/5106107. eCollection 2023.
OBJECTIVE
To determine the impact of the t:slim X2 insulin pump with Control-IQ technology on the quality of life and glycemic control in youth with type 1 diabetes (T1D) and their parents in a real-world setting. . We conducted a single-center, prospective study on pediatric patients (6-18 years old) with T1D using a Tandem t:slim X2 pump and initiating Control-IQ technology as part of routine care. Youth (≥8 years) and parents completed validated patient-reported outcome measures (PROMs) at baseline and the end of the study (16 weeks). Glycemic control measures were recorded at baseline and every 4 weeks until the end of the study.
RESULTS
Fifty-nine youth participated; the median (IQR) age was 13.8 (11.1, 15.7) years, and T1D duration was 6.3 (3.1, 8.4) years. INSPIRE scores (evaluating expectations (baseline) and impact (post) of Control-IQ technology) were favorable, unchanged at the end of the study for youth, and lower for parents ( = 0.04). Other PROM scores improved by the end of the study with mean (95% CI) differences for youth and parents, respectively, as follows: Diabetes Impact and Device Satisfaction (DIDS) Scale Diabetes Impact -1.08 (-1.51, -0.64) ( < 0.001) and -1.41 (-1.96, -0.87) ( < 0.001); DIDS Scale Device Satisfaction +0.43 (0.11, 0.74) ( = 0.01) and +0.58 (0.31, 0.85) ( < 0.001); Hypoglycemia Fear Survey -4.41 (-7.65, -1.17) ( = 0.01) and -7.64 (-11.66, -3.62) ( < 0.001); and WHO-5 Well-Being Index +5.10 (-1.40, 11.6) ( = 0.12) and +9.60 (3.40, 15.8) ( = 0.003). The mean time in range increased from 52.6% at baseline to 62.6% ( < 0.001) at 4 weeks, sustained to 16 weeks.
CONCLUSIONS
Initiation of Control-IQ technology in a real-world setting significantly reduced the impact of diabetes on daily life while simultaneously improving glycemic control. . This trial is registered with ClinicalTrials.gov Identifier NCT04838561 (https://www.clinicaltrials.gov/ct2/show/NCT04838561?term=Control-IQ&cond=Type+1+Diabetes&cntry=CA&draw=2&rank=1).
目的
在真实世界环境中，确定采用Control-IQ技术的t:slim X2胰岛素泵对1型糖尿病（T1D）青少年及其父母生活质量和血糖控制的影响。我们对使用Tandem t:slim X2泵并开始采用Control-IQ技术作为常规护理一部分的T1D儿科患者（6至18岁）进行了一项单中心前瞻性研究。青少年（≥8岁）和父母在基线和研究结束时（16周）完成了经过验证的患者报告结局指标（PROMs）。在基线以及每4周直至研究结束时记录血糖控制指标。
结果
59名青少年参与；年龄中位数（IQR）为13.8（11.1，15.7）岁，T1D病程为6.3（3.1，8.4）年。INSPIRE评分（评估Control-IQ技术的期望（基线）和影响（后期））良好，青少年在研究结束时无变化，而父母的评分较低（P = 0.04）。到研究结束时，其他PROM评分有所改善，青少年和父母的平均（95%CI）差异分别如下：糖尿病影响与设备满意度（DIDS）量表糖尿病影响 -1.08（-1.51，-0.64）（P < 0.001）和 -1.41（-1.96，-0.87）（P < 0.001）；DIDS量表设备满意度 +0.43（0.11，0.74）（P = 0.01）和 +0.58（0.31，0.85）（P < 0.001）；低血糖恐惧调查 -4.41（-7.65，-1.17）（P = 0.01）和 -7.64（-11.66，-3.62）（P < 0.001）；以及世界卫生组织-5幸福指数 +5.10（-1.40，11.6）（P = 0.12）和 +9.60（3.40，15.8）（P = 0.003）。血糖达标平均时间从基线时的52.6%增加到4周时的62.6%（P < 0.001），并持续到16周。
结论
在真实世界环境中启动Control-IQ技术可显著降低糖尿病对日常生活的影响，同时改善血糖控制。本试验已在ClinicalTrials.gov注册，标识符为NCT04838561（https://www.clinicaltrials.gov/ct2/show/NCT04838561?term=Control-IQ&cond=Type+1+Diabetes&cntry=CA&draw=2&rank=1）。
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