Department of Health Science, University Magna Graecia, Catanzaro, Italy.
Department of Clinical and Experimental Medicine, University Magna Graecia, Catanzaro, Italy.
Diabetes Obes Metab. 2020 Jul;22(7):1056-1061. doi: 10.1111/dom.13993. Epub 2020 Feb 27.
This real-world study evaluated the changes in glycated haemoglobin (HbA1c) and continuous glucose monitoring (CGM) metrics associated with use of the implantable 180-day Eversense CGM System (Eversense) in patients with type 1 diabetes.
This was a prospective, multicentre, observational study among adult participants aged ≥18 years with type 1 diabetes across seven diabetes-care centres in Italy who had Eversense inserted for the first time. HbA1c was measured at baseline and at 180 days. Changes in time in range [TIR (glucose 70-180 mg/dL)], time above range [TAR (glucose >180 mg/dL)], time below range [TBR (glucose <70 mg/dL)] and glycaemic variability were also assessed. Data were also analysed by previous CGM use and by mode of insulin delivery.
One-hundred patients were enrolled (mean age 36 ± 12 years, mean baseline HbA1c 7.4 ± 0.92% [57 ± 10 mmol/mol]). Fifty-six per cent of patients were users of the continuous subcutaneous insulin infusion pump and 45% were previous users of CGM. HbA1c significantly decreased in patients after 180 days of sensor wear (-0.43% ± 0.69%, 5 ± 8 mmol/mol, P < 0.0001). As expected, CGM-naïve patients achieved the greatest reduction in HbA1c (-0.74% ± 0.48%, 8 ± 5 mmol/mol). TIR significantly increased and TAR and mean daily sensor glucose significantly decreased while TBR did not change after 180 days of sensor wear.
Real-world clinical use of the Eversense CGM System for 180 days was associated with significant improvements in HbA1c and CGM metrics among adults with type 1 diabetes. The study is registered on clinicaltrials.gov (NCT04160156).
本真实世界研究评估了在 1 型糖尿病患者中使用可植入 180 天 Eversense 连续血糖监测(CGM)系统(Eversense)后,糖化血红蛋白(HbA1c)和连续血糖监测(CGM)指标的变化。
这是一项在意大利 7 家糖尿病护理中心进行的前瞻性、多中心、观察性研究,纳入了年龄≥18 岁、首次植入 Eversense 的成年 1 型糖尿病患者。在基线和 180 天时测量 HbA1c。还评估了时间在范围内(TIR(血糖 70-180mg/dL))、时间在范围之上(TAR(血糖>180mg/dL))、时间在范围之下(TBR(血糖<70mg/dL))和血糖变异性的变化。还根据先前的 CGM 使用情况和胰岛素输送方式分析了数据。
共纳入 100 例患者(平均年龄 36±12 岁,平均基线 HbA1c 7.4±0.92%[57±10mmol/mol])。56%的患者使用连续皮下胰岛素输注泵,45%的患者为 CGM 使用者。在 180 天传感器佩戴后,患者的 HbA1c 显著降低(-0.43%±0.69%,5±8mmol/mol,P<0.0001)。正如预期的那样,CGM 初治患者 HbA1c 降低最大(-0.74%±0.48%,8±5mmol/mol)。在 180 天传感器佩戴后,TIR 显著增加,TAR 和平均每日传感器血糖显著降低,而 TBR 无变化。
在 180 天内,真实世界中使用 Eversense CGM 系统与 1 型糖尿病成人患者的 HbA1c 和 CGM 指标的显著改善相关。该研究在 clinicaltrials.gov(NCT04160156)上注册。