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国际糖尿病闭环试验中基线糖化血红蛋白亚组的血糖结局。

Glycemic Outcomes in Baseline Hemoglobin A1C Subgroups in the International Diabetes Closed-Loop Trial.

机构信息

Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Center for Academic Medicine, Stanford University School of Medicine, Stanford, California, USA.

Jaeb Center for Health Research, Tampa, Florida, USA.

出版信息

Diabetes Technol Ther. 2022 Aug;24(8):588-591. doi: 10.1089/dia.2021.0524. Epub 2022 Feb 8.

Abstract

Using a closed-loop system significantly improves time in range (TIR) 70-180 mg/dL in patients with type 1 diabetes (T1D). In a 6-month RCT, 112 subjects were randomly assigned to closed-loop control (Tandem Control-IQ) after obtaining 2 weeks of baseline Continuous glucose monitoring (CGM) data from sensor-augmented pump therapy. We compared glycemic outcomes from baseline to end of study among subgroups classified by baseline HbA1c levels. All HbA1c subgroups showed an improvement in TIR due to reduction of both hyperglycemia and hypoglycemia. Those with HbA1c <6.5% improved mostly by reducing nocturnal hypoglycemia due to the automated basal insulin adjustments. Those with HbA1c ≥8.5% improved mostly by reducing daytime and nocturnal hyperglycemia due to both automated basal insulin adjustments and correction boluses during the day. There does not appear to be any reason to exclude individuals with T1D from automated insulin delivery based on their HbA1c. Clinical Trial Identifier: NCT03563313.

摘要

闭环系统可显著提高 1 型糖尿病(T1D)患者的血糖控制达标时间(TIR),即在 70-180mg/dL 范围内的时间。在一项为期 6 个月的 RCT 中,112 名受试者在接受 2 周传感器增强型泵治疗的连续血糖监测(CGM)数据后,被随机分配到闭环控制(Tandem Control-IQ)组。我们比较了按基线糖化血红蛋白(HbA1c)水平分类的亚组从基线到研究结束时的血糖结果。所有 HbA1c 亚组的 TIR 均因减少高血糖和低血糖而有所改善。HbA1c<6.5%的患者主要通过自动调整基础胰岛素来减少夜间低血糖来改善血糖控制。HbA1c≥8.5%的患者则主要通过自动调整基础胰岛素和白天校正推注来减少白天和夜间的高血糖来改善血糖控制。HbA1c 水平似乎不能成为将 T1D 患者排除在自动化胰岛素输注之外的理由。临床试验标识符:NCT03563313。

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