Kadiyala Nithya, Lakshman Rama, Allen Janet, Ware Julia, Boughton Charlotte K, Wilinska Malgorzata E, Thankamony Ajay, Hartnell Sara, Thabit Hood, Willemsen Ruben H, Shah Pratik, Hovorka Roman
Wellcome-MRC Institute of Metabolic Science-Metabolic Research Laboratories, University of Cambridge, Cambridge, United Kingdom.
Department of Paediatrics, University of Cambridge, Cambridge, United Kingdom.
Diabetes Technol Ther. 2025 Sep;27(9):719-727. doi: 10.1089/dia.2025.0062. Epub 2025 May 30.
Adolescents with type 1 diabetes (T1D) can struggle to reach recommended HbA1c targets more than other age groups. The safety and efficacy of fully closed-loop (FCL) insulin delivery, which does not require mealtime bolusing, have not been assessed in this cohort. We evaluated the use of FCL with faster insulin aspart (Fiasp) in adolescents with T1D whose HbA1c was above recommended targets. This two-center, randomized, crossover study included 24 adolescents (13-19 years) using insulin pump therapy with above-target HbA1c (mean age 16.2 years, median HbA1c 74 mmol/mol [8.9%]). Participants underwent two 8-week periods of unrestricted living, comparing FCL (CamAPS HX) with Fiasp, with standard nonautomated insulin pump therapy with continuous glucose monitoring (CGM), in random order. In an intention-to-treat analysis, the percentage of time glucose was in target range (primary endpoint 3.9-10.0 mmol/L) was higher during FCL than during pump with CGM use (mean ± standard deviation [SD]) 45.2% ± 7.2% vs. 32.3% ± 12.8%, mean difference 12.9 percentage points, 95% confidence interval [CI] 8.5 to 17.3, < 0.001). Time spent in hyperglycemia >13.9 mmol/L and mean glucose were lower with FCL compared with pump with CGM (median time >13.9 mmol/L 28.7% vs. 39.6%, difference -7.3 percentage points, 95% CI -11.1 to -3.5, < 0.001; mean glucose 11.1 mmol/L vs. 12.7 mmol/L, difference -1.2 mmol/L, 95% CI -1.8 to -0.5, < 0.001). Proportion of time with glucose <3.9 mmol/L was similar between interventions (median: FCL 2.78% vs. pump with CGM 2.97%, difference -0.34 percentage points, 95% CI -1.03 to 0.35, = 0.322). There was no difference in HbA1c after FCL compared with pump with CGM (median: 71 mmol/mol (8.6%) vs. 74 mmol/mol (8.9%), = 0.227). There was no difference in total daily insulin dose ( = 0.276). No severe hypoglycemia or ketoacidosis occurred. FCL insulin delivery with CamAPS HX improved glucose outcomes compared with insulin pump therapy with CGM in adolescents with T1D and HbA1c above target.
与其他年龄组相比，1型糖尿病（T1D）青少年更难达到推荐的糖化血红蛋白（HbA1c）目标。全闭环（FCL）胰岛素给药不需要餐时大剂量注射胰岛素，其安全性和有效性尚未在该队列中进行评估。我们评估了在HbA1c高于推荐目标的T1D青少年中使用FCL联合超速效门冬胰岛素（Fiasp）的情况。这项双中心、随机、交叉研究纳入了24名青少年（13 - 19岁），他们使用胰岛素泵治疗且HbA1c高于目标值（平均年龄16.2岁，HbA1c中位数为74 mmol/mol [8.9%]）。参与者经历了两个为期8周的无限制生活阶段，将FCL（CamAPS HX）与Fiasp进行比较，并与采用持续葡萄糖监测（CGM）的标准非自动化胰岛素泵治疗进行随机排序比较。在意向性分析中，FCL期间血糖处于目标范围（主要终点为3.9 - 10.0 mmol/L）的时间百分比高于使用CGM的胰岛素泵治疗期间（均值±标准差[SD]）分别为45.2% ± 7.2% 与32.3% ± 12.8%，平均差值为12.9个百分点，95%置信区间[CI]为8.5至17.3，P < 0.001）。与使用CGM的胰岛素泵相比，FCL期间处于高血糖（>13.9 mmol/L）的时间和平均血糖水平更低（>13.9 mmol/L的中位时间分别为28.7% 与39.6%，差值为 -7.3个百分点，95% CI为 -11.1至 -3.5，P < 0.001；平均血糖分别为11.1 mmol/L与12.7 mmol/L，差值为 -1.2 mmol/L，95% CI为 -1.8至 -0.5，P < 0.001）。血糖<3.9 mmol/L的时间比例在两种干预措施之间相似（中位数：FCL为2.78%，使用CGM的胰岛素泵为2.97%，差值为 -0.34个百分点，95% CI为 -1.03至0.35，P = 0.322）。与使用CGM的胰岛素泵相比，FCL后HbA1c没有差异（中位数：分别为71 mmol/mol（8.6%）与74 mmol/mol（8.9%），P = 0.227）。每日胰岛素总剂量没有差异（P = 0.276）。未发生严重低血糖或酮症酸中毒。与使用CGM的胰岛素泵治疗相比，在HbA1c高于目标值的T1D青少年中，采用CamAPS HX的FCL胰岛素给药改善了血糖结局。
