Diabetes Research Institute, IRCCS San Raffaele Hospital and San Raffaele Vita Salute University, Milan, Italy.
ASL Toscana Nord Ovest (ATNO), SS Diabetologia Massa Carrara, Carrara, Italy.
Diabetes Res Clin Pract. 2022 Jan;183:109172. doi: 10.1016/j.diabres.2021.109172. Epub 2021 Dec 6.
This prospective, observational cohort study aimed to measure HbA1c change over 3-6 months in type 2 diabetes managed with basal-bolus insulin and FreeStyle Libre® Flash Glucose Monitoring System (FSL) use compared to self-monitored blood glucose (SMBG).
Sixteen Italian hospitals enrolled patients with type 2 diabetes (n = 322, [109 FSL, 213 SMBG users]) using basal-bolus insulin therapy for ≥ 1 year, HbA1c 8.0-12.0% (64-108 mmol/mol), new to FSL use (<3 months) or continuing with SMBG (controls). Eligible FSL and SMBG users were matched (1:2 ratio) for baseline HbA1c (within ± 0.5%, recorded ≤ 3 months previously), study site and baseline data collection date.
Overall, baseline HbA1c was 8.9 ± 0.8% (74 ± 9 mmol/mol), age 67.2 ± 10.0 years, BMI 30.5 ± 6.5 kg/m and insulin use duration 8.6 ± 6.6 years (mean ± SD), 56.2% were males. After 3-6 months, 234 complete cases (83 FSL, 151 SMBG users) demonstrated significantly reduced HbA1c for FSL use compared to SMBG (0.3% ± 0.12 [3 mmol/mol ± 1.3, (mean ± SE)], p = 0.0112). The difference remained statistically significant after adjusting for confounders.
HbA1c significantly improved in basal-bolus treated type 2 diabetes after flash glucose monitoring use for 3-6 months compared to SMBG.
本前瞻性观察队列研究旨在比较基础-餐时胰岛素治疗的 2 型糖尿病患者使用瞬感®血糖仪(FSL)和自我血糖监测(SMBG) 3-6 个月的糖化血红蛋白(HbA1c)变化。
16 家意大利医院纳入了使用基础-餐时胰岛素治疗≥1 年、HbA1c 8.0-12.0%(64-108mmol/mol)、新启用 FSL(<3 个月)或继续 SMBG 的 2 型糖尿病患者(n=322,FSL 组 109 例,SMBG 组 213 例)。符合条件的 FSL 和 SMBG 使用者根据基线 HbA1c(±0.5%内,记录于<3 个月前)、研究地点和基线数据收集日期进行 1:2 匹配。
总体而言,基线 HbA1c 为 8.9±0.8%(74±9mmol/mol),年龄 67.2±10.0 岁,BMI 30.5±6.5kg/m2,胰岛素使用时间 8.6±6.6 年(均值±标准差),56.2%为男性。3-6 个月后,234 例完整病例(FSL 组 83 例,SMBG 组 151 例)显示 FSL 组 HbA1c 显著低于 SMBG 组(0.3%±0.12[3mmol/mol±1.3],p=0.0112)。调整混杂因素后,差异仍具有统计学意义。
与 SMBG 相比,在基础-餐时胰岛素治疗的 2 型糖尿病患者使用瞬感®血糖仪监测血糖 3-6 个月后,HbA1c 显著改善。