1 Barbara Davis Center for Childhood Diabetes, Aurora, Colorado.
2 Edmond and Lily Safra Children's Hospital, Sheba Medical Center, Tel Aviv, Israel.
Diabetes Technol Ther. 2019 Jan;21(1):11-19. doi: 10.1089/dia.2018.0264. Epub 2018 Dec 26.
To evaluate the safety of in-home use of the MiniMed™ 670G system with SmartGuard™ technology in children with type 1 diabetes (T1D).
Participants (N = 105, ages 7-13 years, mean age 10.8 ± 1.8 years) were enrolled at nine centers (eight in the United States and one in Israel) and completed a 2-week baseline run-in phase in Manual Mode followed by a 3-month study phase with Auto Mode enabled. Sensor glucose (SG), glycated hemoglobin (HbA), percentage of SG values across glucose ranges, and SG variability, during the run-in and study phases were compared. Participants underwent frequent sample testing with i-STAT venous reference measurement during a hotel period (6 days/5 nights) to evaluate the system's continuous glucose monitoring performance.
Auto Mode was used a median of 81% of the time. From baseline to end of study, overall SG dropped by 6.9 ± 17.2 mg/dL (P < 0.001), HbA decreased from 7.9% ± 0.8% to 7.5% ± 0.6% (P < 0.001), percentage of time in target glucose range (70-180 mg/dL) increased from 56.2% ± 11.4% to 65.0% ± 7.7% (P < 0.001), and the SG coefficient of variation decreased from 39.6% ± 5.4% to 38.5% ± 3.8% (P = 0.009). The percentage of SG values within target glucose range was 68.2% ± 9.1% and that of i-STAT reference values was 65.6% ± 17.7%. The percentage of values within 20%/20 of the i-STAT reference was 85.2%. There were no episodes of severe hypoglycemia or diabetic ketoacidosis during the study phase.
In-home use of MiniMed 670G system Auto Mode for 3 months by children with T1D, similar to MiniMed 670G system use by adolescents and adults with T1D, was safe and associated with reduced HbA levels and increased time in target glucose range, compared with baseline.
评估 1 型糖尿病（T1D）患儿使用带 SmartGuard™ 技术的 MiniMed™ 670G 系统居家使用的安全性。
共纳入 9 个中心的 105 名参与者（年龄 7-13 岁，平均年龄 10.8±1.8 岁），他们完成了 2 周的手动模式基础期，随后在启用自动模式的情况下进行了 3 个月的研究期。比较基础期和研究期期间传感器血糖（SG）、糖化血红蛋白（HbA）、不同血糖范围内 SG 值的百分比以及 SG 变异性。在酒店期（6 天 5 夜）期间，参与者接受了频繁的 i-STAT 静脉参考测量样本检测，以评估系统的连续血糖监测性能。
自动模式的使用中位数为 81%。从基线到研究结束，总体 SG 下降了 6.9±17.2mg/dL（P<0.001），HbA 从 7.9%±0.8%下降至 7.5%±0.6%（P<0.001），目标血糖范围内的时间百分比（70-180mg/dL）从 56.2%±11.4%增加至 65.0%±7.7%（P<0.001），SG 变异系数从 39.6%±5.4%下降至 38.5%±3.8%（P=0.009）。SG 值在目标血糖范围内的百分比为 68.2%±9.1%，i-STAT 参考值为 65.6%±17.7%。与 i-STAT 参考值相差 20%/20 的百分比为 85.2%。在研究期间，没有发生严重低血糖或糖尿病酮症酸中毒的情况。
与青少年和成年 T1D 患者使用 MiniMed 670G 系统相似，1 型糖尿病患儿居家使用 3 个月 MiniMed 670G 系统自动模式是安全的，与基线相比，HbA 水平降低，目标血糖范围内的时间增加。
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