Department of Medicine, Karolinska University Hospital Huddinge, Karolinska Institute, Stockholm, Sweden.
Department of Molecular and Clinical Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Diabetologia. 2021 Jul;64(7):1595-1603. doi: 10.1007/s00125-021-05437-z. Epub 2021 Mar 27.
AIMS/HYPOTHESIS: The aim of this work was to evaluate changes in glycaemic control (HbA) and rates of severe hypoglycaemia over a 2 year period after initiation of flash glucose monitoring (FM) in type 1 diabetes.
Using data from the Swedish National Diabetes Registry, 14,372 adults with type 1 diabetes with a new registration of FM during 2016-2017 and with continued FM for two consecutive years thereafter, and 7691 control individuals using conventional self-monitoring of blood glucose (SMBG) during the same observation period, were included in a cohort study. Propensity sores and inverse probability of treatment weighting (IPTW) were used to balance FM users with SMBG users. Changes in HbA and events of severe hypoglycaemia were compared.
After the start of FM, the difference in IPTW change in HbA was slightly greater in FM users compared with the control group during the follow-up period, with an estimated mean absolute difference of -1.2 mmol/mol (-0.11%) (95% CI -1.64 [-0.15], -0.75 [-0.07]; p < 0.0001) after 15-24 months. The change in HbA was greatest in those with baseline HbA ≥70 mmol/mol (8.5%), with the estimated mean absolute difference being -2.5 mmol/mol (-0.23%) (95% CI -3.84 [-0.35], -1.18 [-0.11]; p = 0.0002) 15-24 months post index. The change was also significant in the subgroups with initial HbA ≤52 mmol/mol (6.9%) and 53-69 mmol/mol (7.0-8.5%). Risk of severe hypoglycaemic episodes was reduced by 21% for FM users compared with control individuals using SMBG (OR 0.79 [95% CI 0.69, 0.91]; p = 0.0014)].
CONCLUSIONS/INTERPRETATION: In this large cohort, the use of FM was associated with a small and sustained improvement in HbA, most evident in those with higher baseline HbA levels. In addition, FM users experienced lower rates of severe hypoglycaemic events compared with control individuals using SMBG for self-management of glucose control.
目的/假设:本研究旨在评估在 1 型糖尿病患者开始使用瞬态血糖监测(FM)后 2 年内,血糖控制(HbA)和严重低血糖发生率的变化。
使用来自瑞典国家糖尿病登记处的数据,纳入了 14372 名在 2016-2017 年期间新登记 FM 且在随后的两年内连续使用 FM 的成年 1 型糖尿病患者,以及 7691 名在同期使用常规自我监测血糖(SMBG)的对照个体,进行了一项队列研究。采用倾向评分和逆概率处理加权(IPTW)来平衡 FM 用户和 SMBG 用户。比较了 HbA 的变化和严重低血糖事件。
在开始使用 FM 后,在随访期间,与对照组相比,FM 用户的 IPTW 变化中 HbA 的差异略大,估计平均绝对差异为-1.2mmol/mol(-0.11%)(95%CI-1.64[-0.15],-0.75[-0.07];p<0.0001)。在基线 HbA≥70mmol/mol(8.5%)的患者中,HbA 的变化最大,估计平均绝对差异为-2.5mmol/mol(-0.23%)(95%CI-3.84[-0.35],-1.18[-0.11];p=0.0002)。在初始 HbA≤52mmol/mol(6.9%)和 53-69mmol/mol(7.0-8.5%)的亚组中,变化也有统计学意义。与使用 SMBG 的对照组相比,FM 用户发生严重低血糖事件的风险降低了 21%(OR0.79[95%CI0.69,0.91];p=0.0014)。
结论/解释:在这项大型队列研究中,使用 FM 与 HbA 的小幅且持续改善相关,在基线 HbA 水平较高的患者中最为明显。此外,与使用 SMBG 自我管理血糖控制的对照组相比,FM 用户严重低血糖事件的发生率较低。