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山西白求恩医院/山西医学科学院内分泌科,太原 030032
张晨霞,Email:zhangchenxia@sxbqeh.com.cn,研究方向:糖尿病肾病与胰岛素治疗。
刘师伟,Email:lswspring6@aliyun.com。
收稿:2025-08-19,
修回:2025-11-22,
录用:2025-12-11,
纸质出版:2026-10-27
移动端阅览
张晨霞, 刘师伟. 基于动态血糖监测的肾功能分层胰岛素算法在糖尿病肾病患者中的安全性与疗效研究[J/OL]. 重庆医科大学学报, 2026,1-6.
Zhang Chenxia,Liu Shiwei.Safety and efficacy of a renal function-stratified insulin algorithm based on continuous glucose monitoring in patients with diabetic kidney disease[J].Journal of Chongqing Medical University,
张晨霞, 刘师伟. 基于动态血糖监测的肾功能分层胰岛素算法在糖尿病肾病患者中的安全性与疗效研究[J/OL]. 重庆医科大学学报, 2026,1-6. DOI:
Zhang Chenxia,Liu Shiwei.Safety and efficacy of a renal function-stratified insulin algorithm based on continuous glucose monitoring in patients with diabetic kidney disease[J].Journal of Chongqing Medical University, DOI:10.13406/j.cnki.cyxb..
目的
2
探讨基于持续血糖监测(continuous glucose monitoring,CGM)的肾功能分层胰岛素算法在糖尿病肾病(diabetic kidney disease,DKD)患者中的安全性与疗效。
方法
2
纳入2022年1月至2023年12月山西白求恩医院、山西医科大学第一医院、山西医科大学第二医院、太原市中心医院、运城市中心医院的DKD患者[估算肾小球滤过率(estimated glomerular filtration rate,eGFR),15~60 mL/(min·1.73 m
2
)],按1∶1比例随机分为算法干预组(
n
=78)与对照组(
n
=78)。干预组采用基于CGM的数据和肾功能(G3a/G3b/G4)分层的胰岛素剂量调整算法,对照组采用标准胰岛素治疗方案。主要结局为严重低血糖事件发生率(
<
3.0 mmol/L),次要结局包括血糖达标时间[(time in range,TIR),3.9~10.0 mmol/L]和eGFR年下降速率。
结果
2
共156例患者完成24周随访。与对照组相比,干预组严重低血糖发生率明显降低(0.35次/人年 vs. 1.12次/人年,IRR=0.31,
Z
=4.320,
P
<
0.001),TIR提高[(68.3±7.5)% vs.(62.1±8.2)%,
t
=3.150,
P
=0.002],eGFR年下降速率减缓[0.7 mL/(min·1.73 m
2
),
t
=2.050,
P
=0.04)]。分层分析显示,该疗效在G3b期患者中表现更为明显(交互作用
P
=0.021)。
结论
2
基于CGM的肾功能分层胰岛素算法能有效降低DKD患者低血糖风险,改善血糖控制,并可能延缓肾功能减退,尤适用于中重度肾功能减退(G3b期)人群。
Objective
2
To investigate the safety and efficacy of a renal function-stratified insulin algorithm based on continuous glucose monitoring(CGM) in patients with diabetic kidney disease(DKD).
Methods
2
This multicenter was conducted among the DKD patients with an estimated glomerular filtration rate eGFR of 15-60 mL/min/1.73 m
2
who were treated in Shanxi Bethune Hospital,The First Hospital of Shanxi Medical University,the Second Hospital of Shanxi Medical University,Taiyuan Central Hospital,Yuncheng Central Hospital from January 2022 to December 2023,and at a ratio of 1∶1,the patients were randomly divided into algorithm intervention group and control group,with 78 patients in each group. The patients in the algorithm intervention group
received a renal function(G3a/G3b/G4)-stratified insulin dosing algorithm based on CGM data,while those in the control group received standard insulin therapy. The primary outcome was the incidence rate of severe hypoglycemia(
<
3.0 mmol/L),and the secondary outcomes included time in range(TIR,3.9-10.0 mmol/L) and annual rate of eGFR decline.
Results
2
All 156 patients completed the 24-week follow-up. Compared with the control group,the algorithm intervention group had a significantly lower incidence rate of severe hypoglycemia (0.35 vs. 1.12 events per person-year,IRR=0.31,
Z
=4.320,
P
<
0.001),a significantly higher TIR[(68.3±7.5)% vs. (62.1±8.2)%,
t
=3.150,
P
=0.002],and a significantly lower annual rate of eGFR decline (0.7 mL/min/1.73 m
2
,
t
=2.050,
P
=0.043). The stratified analysis showed enhanced benefits in the patients with stage G3b renal function(
P
interaction
=0.021).
Conclusion
2
The renal function-stratified insulin algorithm based on CGM can effectively reduce the risk of hypoglycemia,improve glycemic control,and delay renal function deterioration in DKD patients,especially in those with moderate-to-severe renal impairment(stage G3b).
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