Children's Hospital, Paediatric Research Centre, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
Diabetes Obes Metab. 2024 Jun;26(6):2431-2438. doi: 10.1111/dom.15562. Epub 2024 Mar 21.
To investigate whether the positive effects on glycaemic outcomes of 3-month automated insulin delivery (AID) achieved in 2- to 6-year-old children endure over an extended duration and how AID treatment affects time in tight range (TITR), defined as 3.9-7.8 mmol/L.
We analysed 18 months of follow-up data from a non-randomized, prospective, single-arm clinical trial (n = 35) conducted between 2021 and 2023. The main outcome measures were changes in time in range (TIR), glycated haemoglobin (HbA1c), time above range (TAR), TITR, and mean sensor glucose (SG) value during follow-up visits (at 0, 6, 12 and 18 months). The MiniMed 780G AID system in SmartGuard Mode was used for 18 months. Parental diabetes distress was evaluated at 3 and 18 months with the validated Problem Areas in Diabetes-Parent, revised (PAID-PR) survey.
Between 0 and 6 months, TIR and TITR increased, and HbA1c, mean SG value and TAR decreased significantly (p < 0.001); the favourable effect persisted through 18 months of follow-up. Between 3 and 18 months, PAID-PR score declined significantly (0 months: mean score 37.5; 3 months: mean score 28.6 [p = 0.06]; 18 months: mean score 24.6 [p < 0.001]).
Treatment with AID significantly increased TITR and TIR in young children. The positive effect of AID on glycaemic control observed after 6 months persisted throughout the 18 months of follow-up. Similarly, parental diabetes distress remained reduced during 18 months follow-up. These findings are reassuring and suggest that AID treatment improves glycaemic control and reduces parental diabetes distress in young children over an extended 18-month follow-up.
研究在 2 至 6 岁儿童中，3 个月的自动胰岛素输注（AID）对血糖结果的积极影响是否能持续较长时间，以及 AID 治疗如何影响严格范围内的时间（TITR），定义为 3.9-7.8mmol/L。
我们分析了 2021 年至 2023 年期间进行的一项非随机、前瞻性、单臂临床试验的 18 个月随访数据（n=35）。主要观察指标是在随访期间（0、6、12 和 18 个月时）TIR、糖化血红蛋白（HbA1c）、范围外时间（TAR）、TITR 和平均传感器血糖（SG）值的变化。使用 MiniMed 780G AID 系统的 SmartGuard 模式进行 18 个月的治疗。使用经过验证的糖尿病父母问题领域-修订版（PAID-PR）量表在 3 个月和 18 个月时评估父母的糖尿病困扰。
在 0 至 6 个月期间，TIR 和 TITR 增加，HbA1c、平均 SG 值和 TAR 显著降低（p<0.001）；这种有利影响在 18 个月的随访中持续存在。在 3 至 18 个月期间，PAID-PR 评分显著下降（0 个月：平均评分 37.5；3 个月：平均评分 28.6[p=0.06]；18 个月：平均评分 24.6[p<0.001]）。
AID 治疗显著增加了幼儿的 TITR 和 TIR。在 6 个月后观察到的 AID 对血糖控制的积极影响在 18 个月的随访中持续存在。同样，在 18 个月的随访期间，父母的糖尿病困扰仍然减少。这些发现令人安心，表明 AID 治疗可改善幼儿的血糖控制，并在延长的 18 个月随访期间减轻父母的糖尿病困扰。
