Department of Paediatric Endocrinology, Great Ormond Street Hospital for Children NHS Foundation Trust, London, United Kingdom.
University College London, Institute of Child Health, London, United Kingdom.
Front Endocrinol (Lausanne). 2023 Sep 26;14:1265076. doi: 10.3389/fendo.2023.1265076. eCollection 2023.
Continuous glucose monitoring (CGM) is the standard of care for glucose monitoring in children with diabetes, however there are limited data reporting their use in hyperinsulinaemic hypoglycaemia (HH). Here, we evaluate CGM accuracy and its impact on quality of life in children with HH.
Real-time CGM (Dexcom G5 and G6) was used in children with HH aged 0-16years. Data from self-monitoring capillary blood glucose (CBG) and CGM were collected over a period of up to 28days and analysed. Quality of life was assessed by the PedsQL4.0 general module and PedsQL2.0 family impact module, completed by children and their parents/carers before and after CGM insertion. Analysis of accuracy metrics included mean absolute relative difference (MARD) and proportion of CGM values within 15, 20, and 30% or 15, 20, and 30 mg/dL of reference glucose values >100 mg/dL or ≤100 mg/dL, respectively (% 15/15, % 20/20, % 30/30). Clinical reliability was assessed with Clarke error grid (CEG) analyses.
Prospective longitudinal study with data analysed from 40 children. The overall MARD between reference glucose and paired CGM values (n=4,928) was 13.0% (Dexcom G5 12.8%, Dexcom G6 13.1%). The proportion of readings meeting %15/15 and %20/20 were 77.3% and 86.4%, respectively, with CEG analysis demonstrating 97.4% of all values in zones A and B. Within the hypoglycaemia range (<70 mg/dL), the median ARD was 11.4% with a sensitivity and specificity of 64.2% and 91.3%, respectively. Overall PedsQL child report at baseline and endpoint were 57.6 (50.5 - 75.8) and 87.0 (82.9 - 91.2), and for parents were 60.3 (44.8 - 66.0) and 85.3 (83.7 - 91.3), respectively (both p<0.001).
Use of CGM for children with HH is feasible, with clinically acceptable accuracy, particularly in the hypoglycaemic range. Quality of life measures demonstrate significant improvement after CGM use. These data are important to explore use of CGM in disease indications, including neonatal and paediatric diabetes, cystic fibrosis and glycogen storage disorders.
连续血糖监测（CGM）是儿童糖尿病血糖监测的标准，但在高胰岛素血症性低血糖症（HH）中使用的相关数据有限。在此，我们评估了 CGM 的准确性及其对 HH 患儿生活质量的影响。
0-16 岁 HH 患儿使用实时 CGM（Dexcom G5 和 G6）。在长达 28 天的时间内收集自我监测毛细血管血糖（CBG）和 CGM 的数据，并进行分析。通过儿童及其父母/照顾者在使用 CGM 前后填写 PedsQL4.0 一般模块和 PedsQL2.0 家庭影响模块来评估生活质量。准确性指标的分析包括平均绝对相对差异（MARD）和 CGM 值分别在 15%、20%和 30%或 15%、20%和 30mg/dL 参考血糖值＞100mg/dL 或≤100mg/dL 范围内的比例（%15/15、%20/20、%30/30）。临床可靠性通过 Clarke 误差网格（CEG）分析进行评估。
前瞻性纵向研究，对 40 名儿童的数据进行了分析。参考血糖与配对 CGM 值之间的总体 MARD（n=4928）为 13.0%（Dexcom G5 为 12.8%，Dexcom G6 为 13.1%）。满足%15/15 和%20/20 的读数比例分别为 77.3%和 86.4%，CEG 分析显示所有值的 97.4%均在 A 和 B 区。在低血糖范围（＜70mg/dL）内，中位数 ARD 为 11.4%，敏感性和特异性分别为 64.2%和 91.3%。总体而言，儿童报告的 PedsQL 基线和终点分别为 57.6（50.5-75.8）和 87.0（82.9-91.2），父母的报告分别为 60.3（44.8-66.0）和 85.3（83.7-91.3）（均<0.001）。
CGM 用于 HH 患儿是可行的，具有临床可接受的准确性，特别是在低血糖范围内。生活质量测量表明使用 CGM 后有显著改善。这些数据对于探索 CGM 在疾病指征中的应用非常重要，包括新生儿和儿科糖尿病、囊性纤维化和糖原贮积症。
