Children's Diabetes Centre, Telethon Kids Institute, The University of Western Australia, Perth, Western Australia, Australia.
Department of Endocrinology and Diabetes, Perth Children's Hospital, Perth, Western Australia, Australia.
Diabetes Technol Ther. 2021 Jul;23(7):482-490. doi: 10.1089/dia.2020.0593.
This study evaluated the efficacy of using a hybrid closed loop (HCL) system in restoring hypoglycemia awareness in individuals with impaired awareness of hypoglycemia (IAH). Participants with IAH (Gold score ≥4) were recruited into a randomized crossover pilot study. They participated in two 8-week periods using a HCL system (Medtronic 670G™) (intervention) and standard insulin pump therapy (control). Hyperinsulinemic hypoglycemic clamp studies were undertaken at baseline and at the end of each study period for the evaluation of the counter-regulatory hormonal and symptomatic responses to hypoglycemia. Seventeen participants (mean age [standard deviation] 35.8 years [11.2 years]) were included in the study. Peak epinephrine levels (median, interquartile range [IQR]) in response to hypoglycemia were similar postintervention and control periods; 234.7 pmol/L (109.2; 938.9) versus 188.3 pmol/L (133.7; 402.9), = 0.233. However, both peak adrenergic and neuroglycopenic symptom scores were higher after intervention; 5.0 (4.5; 9.0) versus 4.0 (4.0; 5.5), = 0.009, and 8.5 (6.0; 15.0) versus 6.5 (6.0; 7.0) = 0.014, respectively. Self-reported hypoglycemia awareness improved: median (IQR) Gold score was 4.0 (3.0; 5.5) versus 5.5 (4.5; 6.0); intervention versus control, = 0.033. Time spent <3.9 and <3.0 mmol/L was lower in the intervention group than in control, = 0.002. Other patient-reported outcomes (hypoglycemia fear and diabetes treatment satisfaction) did not change. A short-term use of a HCL system failed to demonstrate an improvement in counter-regulatory hormonal responses. However, higher hypoglycemia symptom scores during controlled hypoglycemia, better self-reported hypoglycemia awareness, and less time spent in hypoglycemia suggest the potential benefits of a HCL system in people with IAH. anzctr.org.au Identifier: ACTRN12616000909426.
这项研究评估了使用混合闭环（HCL）系统恢复低血糖意识受损（IAH）个体低血糖意识的疗效。 招募了 IAH（Gold 评分≥4）的参与者参加一项随机交叉试点研究。他们在两个 8 周的时间内使用 HCL 系统（美敦力 670G™）（干预组）和标准胰岛素泵治疗（对照组）。在基线和每个研究期结束时进行高胰岛素低血糖钳夹研究，以评估低血糖时的代偿性激素和症状反应。 17 名参与者（平均年龄[标准差]35.8 岁[11.2 岁]）纳入研究。低血糖后干预和对照期间肾上腺素峰值水平（中位数，四分位距 [IQR]）相似；234.7pmol/L（109.2；938.9）与 188.3pmol/L（133.7；402.9）， = 0.233。然而，干预后肾上腺素和神经低血糖症状评分均升高；5.0（4.5；9.0）与 4.0（4.0；5.5）， = 0.009，和 8.5（6.0；15.0）与 6.5（6.0；7.0）， = 0.014，分别。自我报告的低血糖意识改善：Gold 评分中位数（IQR）为 4.0（3.0；5.5）与 5.5（4.5；6.0）；干预与对照， = 0.033。干预组<3.9 和 <3.0mmol/L 的时间少于对照组， = 0.002。其他患者报告的结果（低血糖恐惧和糖尿病治疗满意度）没有改变。 HCL 系统的短期使用未能改善代偿性激素反应。然而，在受控低血糖期间更高的低血糖症状评分、更好的自我报告低血糖意识和更少的低血糖时间表明 HCL 系统在 IAH 患者中的潜在益处。 anzctr.org.au 标识符：ACTRN12616000909426。
