Department. of Cardiovascular Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.
Diabetes Care Unit, Internal Medicine, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.
Endocrine. 2024 Apr;84(1):128-135. doi: 10.1007/s12020-023-03651-w. Epub 2024 Jan 10.
Both hyperglycaemia and large glycaemic variability are associated with worse outcomes in patients with Type 2 diabetes mellitus (T2DM), possibly causing sympatho-vagal imbalance and endothelial dysfunction. Continuous subcutaneous insulin injection (CSII) improves glycemic control compared to multiple daily insulin injections (MDI). We aimed to assess whether CSII may improve cardiac autonomic and vascular dilation function compared to MDI.
We enrolled T2DM patients without cardiovascular disease with poor glycaemic control, despite optimized MDI therapy. Patients were randomized to continue MDI (with multiple daily peripheral glucose measurements) or CSII; insulin dose was adjusted to achieve optimal target ranges of blood glucose levels. Patients were studied at baseline and after 6 months by: 1) flow-mediated dilation (FMD) and nitrate-mediated dilation (NMD) of the brachial artery; 2) heart rate variability (HRV) by 24-hour ECG Holter monitoring (HM). 7-day continuous glucose monitoring (CGM) was performed in 9 and 8 patients of Group 1 and 2, respectively.
Overall, 21 patients were enrolled, 12 randomized to CSII (Group 1) and 9 to MDI (Group 2). The daily dose of insulin and Hb1AC did not differ significantly between the 2 groups, both at baseline and at follow-up. Glucose variability showed some significant improvement at follow-up in the whole population, but no differences were observed between the 2 groups. Both FMD and NMD, as well as HRV parameters, showed no significant differences between the 2 groups at 6-month follow-up.
In this randomized small study we show that, in T2DM patients, CSII achieves a similar medium-term glycemic control compared to MDI, without any adverse effect on the cardiovascular system.
高血糖和较大的血糖变异性与 2 型糖尿病(T2DM)患者的不良结局相关,可能导致交感神经-迷走神经失衡和内皮功能障碍。与多次皮下胰岛素注射(MDI)相比,持续皮下胰岛素注射(CSII)可改善血糖控制。我们旨在评估 CSII 是否可改善与 MDI 相比的心脏自主神经和血管扩张功能。
我们纳入了血糖控制不佳但无心血管疾病的 T2DM 患者,尽管接受了优化的 MDI 治疗。患者被随机分为继续 MDI(接受多次外周血糖测量)或 CSII;胰岛素剂量调整以达到最佳血糖目标范围。患者在基线和 6 个月时通过以下方式进行研究:1)肱动脉血流介导的扩张(FMD)和硝酸盐介导的扩张(NMD);2)通过 24 小时心电图 Holter 监测(HM)进行心率变异性(HRV)。第 1 组和第 2 组中分别有 9 名和 8 名患者进行了 7 天连续血糖监测(CGM)。
总体而言,共纳入 21 名患者,12 名随机分配至 CSII(第 1 组),9 名分配至 MDI(第 2 组)。两组在基线和随访时,胰岛素的日剂量和 Hb1AC 均无显著差异。在整个研究人群中,血糖变异性在随访时均有一定程度的改善,但两组间无差异。在 6 个月随访时,两组的 FMD、NMD 以及 HRV 参数均无显著差异。
在这项随机小型研究中,我们表明,在 T2DM 患者中,CSII 与 MDI 相比可实现相似的中期血糖控制,而对心血管系统没有任何不良影响。