基础胰岛素治疗的2型糖尿病患者血糖在目标范围内的时间与糖化血红蛋白的相关性：SWITCH PRO研究的事后分析
Correlation Between Time in Range and HbA1c in People with Type 2 Diabetes on Basal Insulin: Post Hoc Analysis of the SWITCH PRO Study.
作者信息
Goldenberg Ronald M, Aroda Vanita R, Billings Liana K, Donatsky Anders Meller, Frederiksen Marie, Klonoff David C, Kalyanam Balamurali, Bergenstal Richard M
机构信息
LMC Diabetes & Endocrinology, 5-1600 Steeles Ave. West, Concord, ON, L4K 4M2, Canada.
Brigham and Women's Hospital, and Harvard Medical School, Boston, MA, USA.
出版信息
Diabetes Ther. 2023 May;14(5):915-924. doi: 10.1007/s13300-023-01389-2. Epub 2023 Mar 11.
INTRODUCTION
Use of continuous glucose monitoring (CGM) in people with diabetes may provide a more complete picture of glycemic control than glycated hemoglobin (HbA1c) measurements, which do not capture day-to-day fluctuations in blood glucose levels. The randomized, crossover, phase IV SWITCH PRO study assessed time in range (TIR), derived from CGM, following treatment with insulin degludec or insulin glargine U100 in patients with type 2 diabetes at risk for hypoglycemia. This post hoc analysis evaluated the relationship between TIR and HbA1c, following treatment intensification during the SWITCH PRO study.
METHODS
Correlation between absolute values for TIR (assessed over 2-week intervals) and HbA1c, at baseline and at the end of maintenance period 1 (M1; week 18) or maintenance period 2 (M2; week 36), were assessed by linear regression and using the Spearman correlation coefficient (r). These methods were also used to assess correlation between change in TIR and change in HbA1c from baseline to the end of M1, both in the full cohort and in subgroups stratified by baseline median HbA1c (≥ 7.5% [≥ 58.5 mmol/mol] or < 7.5% [< 58.5 mmol/mol]).
RESULTS
A total of 419 participants were included in the analysis. A moderate inverse linear correlation was observed between TIR and HbA1c at baseline (r -0.54), becoming stronger following treatment intensification during maintenance periods M1 (weeks 17-18: r -0.59) and M2 (weeks 35-36: r -0.60). Changes in TIR and HbA1c from baseline to end of M1 were also linearly inversely correlated in the full cohort (r -0.40) and the subgroup with baseline HbA1c ≥ 7.5% (r -0.43). This was less apparent in the subgroup with baseline HbA1c < 7.5% (r -0.17) (p-interaction = 0.07).
CONCLUSION
Results from this post hoc analysis of data from SWITCH PRO, one of the first large interventional clinical studies to use TIR as the primary outcome, further support TIR as a valid clinical indicator of glycemic control.
TRIAL REGISTRATION
ClinicalTrials.gov identifier, NCT03687827.
引言
对于糖尿病患者，使用连续血糖监测（CGM）可能比糖化血红蛋白（HbA1c）测量更能全面反映血糖控制情况，因为HbA1c无法捕捉血糖水平的日常波动。随机、交叉、IV期SWITCH PRO研究评估了2型糖尿病低血糖风险患者在接受德谷胰岛素或甘精胰岛素U100治疗后，基于CGM得出的血糖在目标范围内时间（TIR）。这项事后分析评估了SWITCH PRO研究强化治疗后TIR与HbA1c之间的关系。
方法
通过线性回归和Spearman相关系数（r）评估基线、维持期1（M1；第18周）或维持期2（M2；第36周）结束时，TIR绝对值（每2周评估一次）与HbA1c之间的相关性。这些方法还用于评估全队列以及按基线HbA1c中位数分层的亚组（≥7.5%[≥58.5 mmol/mol]或<7.5%[<58.5 mmol/mol]）中，从基线到M1结束时TIR变化与HbA1c变化之间的相关性。
结果
共有419名参与者纳入分析。基线时TIR与HbA1c之间观察到中度负线性相关（r = -0.54），在维持期M1（第17 - 18周：r = -0.59）和M2（第35 - 36周：r = -0.60）强化治疗后相关性增强。全队列（r = -0.40）以及基线HbA1c≥7.5%的亚组（r = -0.43）中，从基线到M1结束时TIR和HbA1c的变化也呈负线性相关。在基线HbA1c<7.5%的亚组中这种相关性不太明显（r = -0.17）（p交互作用 = 0.07）。
结论
SWITCH PRO是最早将TIR作为主要结局的大型干预性临床研究之一，这项对SWITCH PRO数据的事后分析结果进一步支持TIR作为血糖控制的有效临床指标。
试验注册
ClinicalTrials.gov标识符，NCT0368782。
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