Objectives: Patients with classical type 1 diabetes mellitus (T1DM) require lifelong dependence on exogenous insulin therapy due to pancreatic beta-cell destruction and absolute insulin deficiency. T1DM accounts for about 90% of children with diabetes in China, with a rapid increase in incidence and a younger-age trend. Epidemiological studies have shown that the overall glycated haemoglobin (HbA1c) and compliance rate are low in Chinese children with T1DM. Optimal glucose control is the key for diabetes treatment, and maintaining blood glucose within the target range can prevent or delay chronic vascular complications in patients with T1DM. Therefore, this study aims to investigate the glycemic control of children with T1DM from Hunan and Henan Province with flash glucose monitoring system (FGMS), and to explore factors associated with glycemic variability.
Methods: A total of 215 children with T1DM under 14 years old were enrolled continuously in 16 hospitals from August 2017 to August 2020. All subjects wore a FGMS device to collect glucose data. Correlation of HbA1c, duration of diabetes, or glucose scan rates with glycemic variability was analyzed. Glucose variability was compared according to the duration of diabetes, HbA1c, glucose scan rates and insulin schema.
Results: HbA1c and duration of diabetes were positively correlated with mean blood glucose, standard deviation of glucose, mean amplitude of glucose excursions (MAGE), and coefficient of variation (CV) of glucose (all P<0.01). The glucose scan rates during FGMS wearing was significantly positively correlated with time in range (TIR) (P=0.001) and negatively correlated with MAGE and mean duration of hypoglycemia (all P<0.01). Children with duration ≤1 year had lower time below range (TBR) and MAGE when compared with those with duration >1 year (all P<0.05). TIR and TBR in patients with HbA1c ≤7.5% were higher (TIR: 65% vs 45%, TBR: 5% vs 4%, P<0.05), MAGE was lower (7.0 mmol/L vs 9.4 mmol/L, P<0.001) than those in HbA1c >7.5% group. Compared to the multiple daily insulin injections group, TIR was higher (60% vs 52%, P=0.006), MAGE was lower (P=0.006) in the continuous subcutaneous insulin infusion group. HbA1c was lower in the high scan rates (≥14 times/d) group (7.4% vs 8.0%, P=0.046), TIR was significantly higher (58% vs 47%, P<0.001), and MAGE was lower (P<0.001) than those in the low scan rate (<14 times/d) group.
Conclusions: The overall glycemic control of T1DM patients under 14 years old in Hunan and Henan Province is under a high risk of hypoglycemia and great glycemic variability. Shorter duration of diabetes, targeted HbA1c, higher glucose scan rates, and CSII are associated with less glycemic variability.
目的: 经典1型糖尿病(type 1 diabetes mellitus，T1DM)患者由于胰岛β细胞破坏、胰岛素绝对缺乏，需终身依赖外源性胰岛素治疗。中国糖尿病患儿中T1DM约占90%，发病率快速增加且低龄化严重。流行病学研究显示中国患儿平均糖化血红蛋白(glycated haemoglobin，HbA1c)整体偏高、达标率低。良好的血糖管理是糖尿病治疗的重点，维持血糖在目标范围内可阻止或延缓T1DM患者慢性血管并发症。本研究旨在利用扫描式葡萄糖监测系统(flash glucose monitoring system，FGMS)了解湖南省和河南省T1DM患儿的血糖控制情况，分析该群体血糖波动的影响因素。方法: 选择2017年8月至2020年8月于两省16所医院内分泌科就诊的T1DM患儿215例，年龄≤14岁，均佩戴FGMS采集血糖数据，分析HbA1c、病程和葡萄糖扫描频率与血糖波动的相关性；根据患儿病程、HbA1c、葡萄糖扫描频率及胰岛素注射方式等因素进行分组比较。结果: HbA1c、病程与平均血糖、血糖标准差、平均血糖波动幅度(mean amplitude of glucose excursions，MAGE)、血糖变异系数(coefficient of variation，CV)呈正相关(均P<0.01)；佩戴FGMS期间葡萄糖扫描频率与目标范围内时间百分比(time in range，TIR)呈明显正相关(P=0.001)，与MAGE和平均低血糖持续时间呈负相关(P<0.01)。病程≤1年组低于目标范围内时间百分比(time below range，TBR)、MAGE均低于病程>1年组(分别4% vs 5%和7.1 mmol/L vs 8.3 mmol/L，均P<0.05)。HbA1c≤7.5%组TIR和TBR高于HbA1c>7.5%组(TIR：65% vs 45%，TBR：5% vs 4%，均P<0.05)，MAGE小于HbA1c>7.5%组(7.0 mmol/L vs 9.4 mmol/L，P<0.01)。持续皮下胰岛素输注组TIR高于每日多次胰岛素注射组(60% vs 52%，P=0.006)，MAGE小于每日多次胰岛素注射组(7.3 mmol/L vs 8.3 mmol/L，P=0.006)。扫描频率≥14次/d组HbA1c低于扫描频率<14次/d组(7.4% vs 8.0%，P=0.046)，TIR高于扫描频率<14次/d组(58% vs 47%，P<0.001)，MAGE小于扫描频率<14次/d组 (7.6 mmol/L vs 8.9 mmol/L，P=0.004)。结论: 两省T1DM患儿整体血糖控制欠佳，血糖波动幅度大，低血糖发生率高。病程较短、HbA1c控制达标、葡萄糖扫描频率高及采用持续皮下胰岛素输注的T1DM患儿血糖波动较小。.
Keywords: flash glucose monitoring system; glycemic variability; type 1 diabetes mellitus.