闭环葡萄糖控制与带持续血糖监测的胰岛素泵治疗在血糖控制不佳的 1 型糖尿病成人中的比较：一项单中心、随机、交叉研究。
Fully Closed-Loop Glucose Control Compared With Insulin Pump Therapy With Continuous Glucose Monitoring in Adults With Type 1 Diabetes and Suboptimal Glycemic Control: A Single-Center, Randomized, Crossover Study.
机构信息
Wellcome-MRC Institute of Metabolic Science, Addenbrooke's Hospital, Cambridge, U.K.
Cambridge University Hospitals NHS Foundation Trust, Wolfson Diabetes and Endocrine Clinic, Cambridge, U.K.
出版信息
Diabetes Care. 2023 Nov 1;46(11):1916-1922. doi: 10.2337/dc23-0728.
OBJECTIVE
We evaluated the safety and efficacy of fully closed-loop with ultrarapid insulin lispro in adults with type 1 diabetes and suboptimal glycemic control compared with insulin pump therapy with continuous glucose monitoring (CGM).
RESEARCH DESIGN AND METHODS
This single-center, randomized, crossover study enrolled 26 adults with type 1 diabetes using insulin pump therapy with suboptimal glycemic control (mean ± SD, age 41 ± 12 years, HbA1c 9.2 ± 1.1% [77 ± 12 mmol/mol]). Participants underwent two 8-week periods of unrestricted living to compare fully closed-loop with ultrarapid insulin lispro (CamAPS HX system) with insulin pump therapy with CGM in random order.
RESULTS
In an intention-to-treat analysis, the proportion of time glucose was in range (primary end point 3.9-10.0 mmol/L) was higher during closed-loop than during pump with CGM (mean ± SD 50.0 ± 9.6% vs. 36.2 ± 12.2%, mean difference 13.2 percentage points [95% CI 9.5, 16.9], P < 0.001). Time with glucose >10.0 mmol/L and mean glucose were lower during closed-loop than during pump with CGM (mean ± SD time >10.0 mmol/L: 49.0 ± 9.9 vs. 62.9 ± 12.6%, mean difference -13.3 percentage points [95% CI -17.2, -9.5], P < 0.001; mean ± SD glucose 10.7 ± 1.1 vs. 12.0 ± 1.6 mmol/L, mean difference -1.2 mmol/L [95% CI -1.8, -0.7], P < 0.001). The proportion of time with glucose <3.9 mmol/L was similar between periods (median [interquartile range (IQR)] closed-loop 0.88% [0.51-1.55] vs. pump with CGM 0.64% [0.28-1.10], P = 0.102). Total daily insulin requirements did not differ (median [IQR] closed-loop 51.9 units/day [35.7-91.2] vs. pump with CGM 50.7 units/day [34.0-70.0], P = 0.704). No severe hypoglycemia or ketoacidosis occurred.
CONCLUSIONS
Fully closed-loop insulin delivery with CamAPS HX improved glucose control compared with insulin pump therapy with CGM in adults with type 1 diabetes and suboptimal glycemic control.
目的
我们评估了与带连续血糖监测（CGM）的胰岛素泵治疗相比，在血糖控制不佳的 1 型糖尿病成人中使用完全闭环加用超速效赖脯胰岛素的安全性和疗效。
研究设计和方法
这项单中心、随机、交叉研究纳入了 26 名正在使用胰岛素泵治疗且血糖控制不佳（平均 ± 标准差，年龄 41 ± 12 岁，HbA1c9.2 ± 1.1%[77 ± 12mmol/mol]）的 1 型糖尿病成人患者。参与者进行了两个 8 周的无限制生活期，以随机顺序比较完全闭环加用超速效赖脯胰岛素（CamAPS HX 系统）与胰岛素泵加 CGM 治疗。
结果
意向治疗分析中，闭环时血糖处于目标范围（主要终点 3.9-10.0mmol/L）的时间比例高于泵加 CGM 时（平均 ± 标准差 50.0 ± 9.6% vs. 36.2 ± 12.2%，平均差值 13.2 个百分点[95%CI9.5,16.9]，P＜0.001）。闭环时血糖＞10.0mmol/L 的时间和平均血糖均低于泵加 CGM 时（平均 ± 标准差血糖＞10.0mmol/L：49.0 ± 9.9 vs. 62.9 ± 12.6%，平均差值-13.3 个百分点[95%CI-17.2,-9.5]，P＜0.001；平均 ± 标准差血糖 10.7 ± 1.1 vs. 12.0 ± 1.6mmol/L，平均差值-1.2mmol/L[95%CI-1.8,-0.7]，P＜0.001）。两个时期血糖＜3.9mmol/L 的时间比例相似（中位数[四分位间距（IQR）]闭环 0.88%[0.51-1.55] vs. 泵加 CGM 0.64%[0.28-1.10]，P=0.102）。每日总胰岛素需求无差异（中位数[IQR]闭环 51.9 单位/天[35.7-91.2] vs. 泵加 CGM 50.7 单位/天[34.0-70.0]，P=0.704）。无严重低血糖或酮症酸中毒发生。
结论
在血糖控制不佳的 1 型糖尿病成人中，与带 CGM 的胰岛素泵治疗相比，CamAPS HX 完全闭环胰岛素输送改善了血糖控制。
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