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1型糖尿病患者慢性并发症与血糖严格控制时间及血糖达标时间的相关性:一项回顾性横断面真实世界研究

The association of chronic complications with time in tight range and time in range in people with type 1 diabetes: a retrospective cross-sectional real-world study.

作者信息

De Meulemeester Jolien, Charleer Sara, Visser Margaretha M, De Block Christophe, Mathieu Chantal, Gillard Pieter

机构信息

Department of Endocrinology, University Hospitals Leuven - KU Leuven, Leuven, Belgium.

Department of Endocrinology, Diabetology & Metabolism, University Hospital Antwerp - University of Antwerp, Edegem, Belgium.

出版信息

Diabetologia. 2024 Aug;67(8):1527-1535. doi: 10.1007/s00125-024-06171-y. Epub 2024 May 24.

Abstract

AIMS/HYPOTHESIS: The aim of this study was to evaluate the association of chronic complications with time in tight range (TITR: 3.9-7.8 mmol/l) and time in range (TIR: 3.9-10.0 mmol/l) in people with type 1 diabetes.

METHODS

The prevalence of microvascular complications (diabetic retinopathy, diabetic nephropathy and diabetic peripheral neuropathy [DPN]) and macrovascular complications according to sensor-measured TITR/TIR was analysed cross-sectionally in 808 adults with type 1 diabetes. Binary logistic regression was used to evaluate the association between TITR/TIR and the presence of complications without adjustment, with adjustment for HbA, and with adjustment for HbA and other confounding factors (sex, age, diabetes duration, BMI, BP, lipid profile, smoking, and use of statins and renin-angiotensin-aldosterone system inhibitors).

RESULTS

The mean TITR and TIR were 33.9 ± 12.8% and 52.5 ± 15.0%, respectively. Overall, 46.0% had any microvascular complication (34.5% diabetic retinopathy, 23.8% diabetic nephropathy, 16.0% DPN) and 16.3% suffered from any macrovascular complication. The prevalence of any microvascular complication, diabetic retinopathy, diabetic nephropathy and a cerebrovascular accident (CVA) decreased with increasing TITR/TIR quartiles (all p<0.05). Each 10% increase in TITR was associated with a lower incidence of any microvascular complication (OR 0.762; 95% CI 0.679, 0.855; p<0.001), diabetic retinopathy (OR 0.757; 95% CI 0.670, 0.856; p<0.001), background diabetic retinopathy (OR 0.760; 95% CI 0.655, 0.882; p<0.001), severe diabetic retinopathy (OR 0.854; 95% CI 0.731, 0.998; p=0.048), diabetic nephropathy (OR 0.799; 95% CI 0.699, 0.915; p<0.001), DPN (OR 0.837; 95% CI 0.717, 0.977; p=0.026) and CVA (OR 0.651; 95% CI 0.470, 0.902; p=0.010). The independent association of TITR with any microvascular complication (OR 0.867; 95% CI 0.762, 0.988; p=0.032), diabetic retinopathy (OR 0.837; 95% CI 0.731, 0.959; p=0.010), background diabetic retinopathy (OR 0.831; 95% CI 0.705, 0.979; p=0.027) and CVA (OR 0.619; 95% CI 0.426, 0.899; p=0.012) persisted after adjustment for HbA. Similar results were obtained when controlling for HbA and other confounding factors.

CONCLUSIONS/INTERPRETATION: TITR and TIR are inversely associated with the presence of microvascular complications and CVA in people with type 1 diabetes. Although this study was not designed to establish a causal relationship, this analysis adds validity to the use of TITR and TIR as key measures in glycaemic management.

TRIAL REGISTRATION

ClinicalTrials.gov NCT02601729 and NCT02898714.

摘要

目的/假设:本研究旨在评估1型糖尿病患者慢性并发症与严格血糖范围时间(TITR:3.9 - 7.8 mmol/l)及血糖正常范围时间(TIR:3.9 - 10.0 mmol/l)之间的关联。

方法

对808例成年1型糖尿病患者进行横断面分析,根据传感器测量的TITR/TIR分析微血管并发症(糖尿病视网膜病变、糖尿病肾病和糖尿病周围神经病变[DPN])及大血管并发症的患病率。采用二元逻辑回归评估TITR/TIR与并发症存在之间的关联,分别进行未调整、调整糖化血红蛋白(HbA)以及调整HbA和其他混杂因素(性别、年龄、糖尿病病程、体重指数、血压、血脂谱、吸烟以及他汀类药物和肾素 - 血管紧张素 - 醛固酮系统抑制剂的使用情况)的分析。

结果

平均TITR和TIR分别为33.9 ± 12.8%和52.5 ± 15.0%。总体而言,46.0%的患者有任何微血管并发症(34.5%为糖尿病视网膜病变,23.8%为糖尿病肾病,16.0%为DPN),16.3%的患者有任何大血管并发症。随着TITR/TIR四分位数增加,任何微血管并发症、糖尿病视网膜病变、糖尿病肾病和脑血管意外(CVA)的患病率均降低(所有p<0.05)。TITR每增加10%,与任何微血管并发症(比值比[OR] 0.762;95%置信区间[CI] 0.679, 0.855;p<0.001)、糖尿病视网膜病变(OR 0.757;95% CI 0.670, 0.856;p<0.001)、背景性糖尿病视网膜病变(OR 0.760;95% CI 0.655, 0.882;p<0.001)、重度糖尿病视网膜病变(OR 0.854;95% CI 0.731, 0.998;p = 0.048)、糖尿病肾病(OR 0.799;95% CI 0.699, 0.915;p<0.001)、DPN(OR 0.837;95% CI 0.717, 0.977;p = 0.026)和CVA(OR 0.651;95% CI 0.470, 0.902;p = 0.010)的发生率降低相关。调整HbA后,TITR与任何微血管并发症(OR 0.867;95% CI 0.762, 0.988;p = 0.032)、糖尿病视网膜病变(OR 0.837;95% CI 0.731, 0.959;p = 0.010)、背景性糖尿病视网膜病变(OR 0.831;95% CI 0.705, 0.979;p = 0.027)和CVA(OR 0.619;95% CI 0.426, 0.899;p = 0.012)的独立关联仍然存在。在控制HbA和其他混杂因素时也得到了类似结果。

结论/解读:TITR和TIR与1型糖尿病患者微血管并发症和CVA的存在呈负相关。尽管本研究并非旨在建立因果关系,但该分析为将TITR和TIR用作血糖管理的关键指标增添了有效性。

试验注册

ClinicalTrials.gov NCT02601729和NCT02898714。

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