基于持续葡萄糖监测的胰岛素滴定方案在2型糖尿病和糖尿病前期心脏手术后患者中的应用：一项随机对照试验。
Use of an insulin titration protocol based on continuous glucose monitoring in postoperative cardiac surgery patients with type 2 diabetes and prediabetes: a randomized controlled trial.
作者信息
Moon Sun-Joon, Kim Min-Su, Kim Yun Tae, Lee Ha-Eun, Lee Young-Woo, Lee Su-Ji, Chung Euy-Suk, Park Cheol-Young
机构信息
Division of Endocrinology and Metabolism, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul, 03181, Republic of Korea.
Thoracic and Cardiovascular Surgery, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul, 03181, Republic of Korea.
出版信息
Cardiovasc Diabetol. 2025 May 14;24(1):210. doi: 10.1186/s12933-025-02747-z.
BACKGROUND
Maintaining optimal glucose control is critical for postoperative care cardiac surgery patients. Continuous glucose monitoring (CGM) in this setting remains understudied. We evaluated the efficacy of CGM with a specialized titration protocol in cardiac surgery patients with type 2 diabetes (T2D) and prediabetes.
METHODS
In this randomized-controlled trial, 54 cardiac surgery patients were randomized one day post-surgery, with 27 CGM and 25 point-of-care (POC) patients completing the study. The CGM group used Dexcom G6 with a CGM-specialized titration protocol, while the POC group used standard monitoring with blinded CGM. The primary outcome was time-in-range (TIR) 100-180 mg/dL for 7 days post-surgery. Secondary outcomes included various glycemic metrics and surgical outcomes. Multiple comparison adjustments were performed using false-discovery-rate (FDR).
RESULTS
Thirty-one (59.6%) had diabetes and 21 (40.4%) had prediabetes. While TIR 100-180 mg/dL showed no difference (74.7% vs. 71.6%, FDR-adjusted p = 0.376), the CGM group demonstrated improvements in TIR 70-180 mg/dL (83.8% vs. 75.8%, FDR-adjusted p = 0.026), time-in-tight-range (TITR) 100-140 mg/dL (46.3% vs. 36.3%, FDR-adjusted p = 0.018), and TITR 70-140 mg/dL (55.3% vs. 40.5%, FDR-adjusted p = 0.003). Both groups maintained very low rates of time below range (< 70 mg/dL: 0.03% vs. 0.18%, FDR-adjusted p = 0.109). The CGM group showed lower postoperative atrial fibrillation (AF) (18.8% vs. 55.6%, FDR-adjusted p = 0.04999).
CONCLUSION
While the primary outcome was not achieved, CGM with a specialized titration protocol demonstrated safe glycemic control with improvements in TIR 70-180 mg/dL and TITRs in cardiac surgery patients with T2D and prediabetes. The observed reduction in postoperative AF warrants further investigation.
TRIAL REGISTRATION
ClinicalTrials.gov NCT06275971.
背景
维持最佳血糖控制对心脏手术患者的术后护理至关重要。在这种情况下，连续血糖监测（CGM）仍未得到充分研究。我们评估了采用专门滴定方案的CGM对2型糖尿病（T2D）和糖尿病前期心脏手术患者的疗效。
方法
在这项随机对照试验中，54名心脏手术患者在术后一天被随机分组，27名CGM组患者和25名即时检测（POC）组患者完成了研究。CGM组使用德康G6并采用专门针对CGM的滴定方案，而POC组使用标准监测并结合盲法CGM。主要结局是术后7天内血糖在100 - 180mg/dL范围内的时间（TIR）。次要结局包括各种血糖指标和手术结局。使用错误发现率（FDR）进行多重比较调整。
结果
31名（59.6%）患有糖尿病，21名（40.4%）患有糖尿病前期。虽然血糖在100 - 180mg/dL范围内的时间（TIR）没有差异（74.7%对71.6%，FDR调整后p = 0.376），但CGM组在血糖在70 - 180mg/dL范围内的时间（TIR）（83.8%对75.8%，FDR调整后p = 0.026）、血糖在100 - 140mg/dL的严格范围内的时间（TITR）（46.3%对36.3%，FDR调整后p = 0.018）以及血糖在70 - 140mg/dL的严格范围内的时间（TITR）（55.3%对40.5%，FDR调整后p = 0.003）方面有改善。两组血糖低于范围的时间（<70mg/dL）发生率都非常低（0.03%对0.18%，FDR调整后p = 0.109）。CGM组术后房颤（AF）发生率较低（18.8%对55.6%，FDR调整后p = 0.04999）。
结论
虽然未达到主要结局，但采用专门滴定方案的CGM在T2D和糖尿病前期心脏手术患者中显示出安全的血糖控制，血糖在70 - 180mg/dL范围内的时间（TIR）和严格范围内的时间（TITR）有所改善。观察到的术后房颤减少值得进一步研究。
试验注册
ClinicalTrials.gov NCT06275971
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