Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.
Front Endocrinol (Lausanne). 2022 Apr 27;13:791439. doi: 10.3389/fendo.2022.791439. eCollection 2022.
To examine the glycaemic variability and safety of basal and premixed insulin by using continuous glucose monitoring (CGM) systems.
393 patients with type 2 diabetes mellitus (T2DM) treated with basal or premixed insulin for more than 3 months were enrolled. Patients were classified into a basal insulin group or premixed insulin group according to their insulin regimens. CGMs were used for 72 h with their previous hypoglycaemic regimen unchanged. The following glycaemic parameters were calculated for each 24 h using CGM data.
Despite similar HbA1c and fasting C-peptide concentrations, glycaemic variability (GV), including the mean amplitude of glycaemic excursion (MAGE), standard deviation (SD) and coefficient of variation (CV), and the time below range (TBR) were significantly lower in the basal insulin group than these in the premixed insulin group. Night-time hypoglycaemia was lower in the basal insulin group than that in the premixed insulin group (p<0.01). Among participants with haemoglobin A1c (HbA1c) < 7%, the GV and TBR were higher in the premixed insulin group than that in the basal insulin group.
Compared with basal insulin, the patients who use premixed insulin had higher GV, smaller TIR and an increased incidence of hypoglycaemia. For patients who use premixed insulin and with HbA1c < 7%, more attention needs to be given to hypoglycaemic events and asymptomatic hypoglycaemia.
ClinicalTrials.gov, identifier NCT03566472.
使用连续血糖监测(CGM)系统检查基础和预混胰岛素的血糖变异性和安全性。
纳入 393 例接受基础或预混胰岛素治疗超过 3 个月的 2 型糖尿病(T2DM)患者。根据胰岛素方案将患者分为基础胰岛素组或预混胰岛素组。CGM 应用 72 小时,不改变先前的低血糖方案。使用 CGM 数据计算每个 24 小时的以下血糖参数。
尽管糖化血红蛋白(HbA1c)和空腹 C 肽浓度相似,但基础胰岛素组的血糖变异性(GV),包括血糖波动幅度(MAGE)、标准差(SD)和变异系数(CV)以及血糖低于目标范围的时间(TBR)均明显低于预混胰岛素组。基础胰岛素组夜间低血糖发生率低于预混胰岛素组(p<0.01)。在 HbA1c<7%的参与者中,预混胰岛素组的 GV 和 TBR 高于基础胰岛素组。
与基础胰岛素相比,使用预混胰岛素的患者血糖变异性更高,TIR 更小,低血糖发生率增加。对于使用预混胰岛素且 HbA1c<7%的患者,需要更加注意低血糖事件和无症状性低血糖。
ClinicalTrials.gov,标识符 NCT03566472。