1 型糖尿病成人间歇性扫描连续血糖监测：FLASH-UK 研究的亚组分析。
Intermittently scanned continuous glucose monitoring in adults with type 1 diabetes: A subgroup analysis from the FLASH-UK study.
机构信息
Manchester Diabetes Centre, Manchester Royal Infirmary, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.
Division of Diabetes, Endocrinology and Gastroenterology, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.
出版信息
Diabet Med. 2024 Mar;41(3):e15249. doi: 10.1111/dme.15249. Epub 2023 Nov 5.
AIMS
The FLASH-UK trial showed lower HbA1c with intermittently scanned continuous glucose monitoring (isCGM), as compared with self monitoring of blood glucose (SMBG), in adults with type 1 diabetes and HbA1c ≥58 mmol/mol (≥7.5%). Here, we present results from the pre-specified subgroup analysis for the 24-week HbA1c (primary outcome) and selected sensor-based secondary outcomes.
METHODS
This was a multi-centre, parallel-design, randomised controlled trial. The difference in treatment effect between subgroups (baseline HbA1c [≤75 vs. >75 mmol/mol] [≤9.0 vs >9.0%], treatment modality [pump vs injections], prior participation in structured education, age, educational level, impaired awareness of hypoglycaemia, deprivation index quintile sex, ethnic group and Patient Health Questionnaire-9 [PHQ-9] detected depression category) were evaluated.
RESULTS
One hundred fifty-six participants (females 44%, mean [SD] baseline HbA1c 71 [9] mmol/mol 8.6 [0.8%], age 44 [15]) were randomly assigned, in a 1:1 ratio to isCGM (n = 78) or SMBG (n = 78). The mean (SD) baseline HbA1c (%) was 8.7 (0.9) in the isCGM group and 8.5 (0.8) in the SMBG group, lowering to 7.9 (0.8) versus 8.3 (0.9), respectively, at 24 weeks (adjusted mean difference -0.5, 95% confidence interval [CI] -0.7 to -0.3; p < 0.001]. For HbA1c, there was no impact of treatment modality, prior participation in structured education, deprivation index quintile, sex or baseline depression category. The between-group difference in HbA1c was larger for younger people (a reduction of 2.7 [95% CI 0.3-5.0; p = 0.028] mmol/mol for every additional 15 years of age). Those with HbA1c 76-97 mmol/mol (>9.0%-11.0%) had a marginally non-significant higher reduction in HbA1c of 8.4 mmol/mol (3.3-13.5) compared to 3.1 (0.3-6.0) in those with HbA1c 58-75 mmol/mol (p = 0.08). For 'Time in range' (% 3.9-10 mmol/L), the difference was larger for those with at least a bachelor's degree. For 'Time below range' (% <3.9 mmol/L), the difference was larger for those using injections, older people and those with less than bachelor's degree.
CONCLUSIONS
Intermittently scanned continuous glucose monitoring is generally effective across a range of baseline characteristics.
目的
FLASH-UK 试验表明，与自我血糖监测（SMBG）相比，1 型糖尿病患者的 HbA1c≥58mmol/mol（≥7.5%）时，间歇性扫描连续血糖监测（isCGM）可降低 HbA1c。在这里，我们报告了针对 24 周 HbA1c（主要结局）和选定基于传感器的次要结局的预先指定亚组分析的结果。
方法
这是一项多中心、平行设计、随机对照试验。在亚组（基线 HbA1c[≤75 与>75mmol/mol][≤9.0 与>9.0%]、治疗方式[泵与注射]、先前参加结构化教育、年龄、教育水平、低血糖意识受损、剥夺指数五分位数性别、种族和患者健康问卷-9[PHQ-9]检测到的抑郁类别）之间，评估了治疗效果的差异。
结果
156 名参与者（女性 44%，平均[标准差]基线 HbA1c71[9]mmol/mol 8.6[0.8%]，年龄 44[15]）以 1:1 的比例随机分配至 isCGM（n=78）或 SMBG（n=78）组。isCGM 组的平均（标准差）基线 HbA1c（%）为 8.7（0.9），SMBG 组为 8.5（0.8），24 周时分别降至 7.9（0.8）和 8.3（0.9）（调整后的平均差值-0.5，95%置信区间[CI]-0.7 至-0.3；p<0.001）。对于 HbA1c，治疗方式、先前参加结构化教育、剥夺指数五分位数、性别或基线抑郁类别均无影响。年轻人的组间 HbA1c 差异更大（每增加 15 岁，HbA1c 降低 2.7[95%CI 0.3-5.0；p=0.028]mmol/mol）。HbA1c 为 76-97mmol/mol（9.0%-11.0%）的患者与 HbA1c 为 58-75mmol/mol（3.1[0.3-6.0]mmol/mol）的患者相比，HbA1c 降低幅度略无统计学意义，为 8.4mmol/mol（3.3-13.5）（p=0.08）。对于“时间在范围内”（%3.9-10mmol/L），具有学士学位及以上学历者差异更大。对于“时间在范围以下”（%<3.9mmol/L），使用注射剂、年龄较大和学历较低者差异更大。
结论
间歇性扫描连续血糖监测在一系列基线特征中普遍有效。
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