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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.

DOI:10.1186/s12933-025-02747-z
PMID:40369552
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12079838/
Abstract

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.

摘要

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

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e68a/12079838/d7e238547e6b/12933_2025_2747_Fig3_HTML.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e68a/12079838/f12bd53b663b/12933_2025_2747_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e68a/12079838/d7e238547e6b/12933_2025_2747_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e68a/12079838/db5b38251527/12933_2025_2747_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e68a/12079838/f12bd53b663b/12933_2025_2747_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e68a/12079838/d7e238547e6b/12933_2025_2747_Fig3_HTML.jpg

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