■在1型糖尿病和低血糖(IAH)意识受损的高危人群中,混合闭环(HCL)系统的益处尚未得到充分探索。
■埃德蒙顿HYPO评分≥1047的成年人随机接受26周HCL(MiniMed™670G)与标准治疗(每日多次注射或胰岛素泵),不进行连续血糖监测(CGM)(对照)。主要结果是随机化后23至26周的CGM时间范围百分比(TIR;70-180mg/dL)。主要次要终点包括随机化后26周的反调节激素变化幅度和对低血糖的自主神经症状反应。事后分析评估了在随机化后26周时比较HCL与对照组的血糖风险指数(GRI)。
■9名参与者(中位数[四分位距(IQR)]年龄51[41,59]岁;44%男性;入组HYPO评分1183[1058,1308];Clarke评分6[6,6];n=5[HCL];n=4[对照])完成了研究。使用HCL的时间范围高于对照(70%[68,74%]vs48%[44,50%],P=.014)。时间<70mg/dL没有差异(HCL3.8%[2.7,3.9]vs对照6.5%[4.3,8.6],P=.14)尽管低血糖发作持续时间较短(30vs50分钟,P<.001)与HCL。HCL患者血糖风险指数低于对照组(38.1[30.0,39.2]vs70.8[58.5,72.4],P=.014)。使用HCL6个月后,多巴胺增加(24.0[12.3,27.6]vs-18.5[-36.5,-4.8],P=.014),和生长激素(6.3[4.6,16.8]vs0.5[-0.8,3.0],P=.050)观察到对低血糖的反应。
■在严重IAH的高危成人中使用HCL6个月可增加血糖TIR并改善GRI而不增加低血糖,并部分恢复了反监管反应。
■ACTRN12617000520336。
UNASSIGNED: Benefits of hybrid closed-loop (HCL) systems in a high-risk group with type 1 diabetes and impaired awareness of hypoglycemia (IAH) have not been well-explored.
UNASSIGNED: Adults with Edmonton HYPO scores ≥1047 were randomized to 26-weeks HCL (MiniMed™ 670G) vs standard therapy (multiple daily injections or insulin pump) without continuous glucose monitoring (CGM) (control). Primary outcome was percentage CGM time-in-range (TIR; 70-180 mg/dL) at 23 to 26 weeks post-randomization. Major secondary endpoints included magnitude of change in counter-regulatory hormones and autonomic symptom responses to hypoglycemia at 26-weeks post-randomization. A post hoc analysis evaluated glycemia risk index (GRI) comparing HCL with control groups at 26 weeks post-randomization.
UNASSIGNED: Nine participants (median [interquartile range (IQR)] age 51 [41, 59] years; 44% male; enrolment HYPO score 1183 [1058, 1308]; Clarke score 6 [6, 6]; n = 5 [HCL]; n = 4 [control]) completed the study. Time-in-range was higher using HCL vs control (70% [68, 74%] vs 48% [44, 50%], P = .014). Time <70 mg/dL did not differ (HCL 3.8% [2.7, 3.9] vs control 6.5% [4.3, 8.6], P = .14) although hypoglycemia episode duration was shorter (30 vs 50 minutes, P < .001) with HCL. Glycemia risk index was lower with HCL vs control (38.1 [30.0, 39.2] vs 70.8 [58.5, 72.4], P = .014). Following 6 months of HCL use, greater dopamine (24.0 [12.3, 27.6] vs -18.5 [-36.5, -4.8], P = .014), and growth hormone (6.3 [4.6, 16.8] vs 0.5 [-0.8, 3.0], P = .050) responses to hypoglycemia were observed.
UNASSIGNED: Six months of HCL use in high-risk adults with severe IAH increased glucose TIR and improved GRI without increased hypoglycemia, and partially restored counter-regulatory responses.
UNASSIGNED: ACTRN12617000520336.