Aim

To compare accuracy, efficacy and acceptance of implantable and transcutaneous continuous glucose monitoring (CGM) systems.

Methods

In a randomized crossover trial we compared 12 weeks with Eversense implantable sensor (EVS) and 12 weeks with Dexcom G5 transcutaneous sensor (DG5) in terms of accuracy, evaluated as Mean Absolute Relative Difference (MARD) vs capillary glucose (SMBG), time of CGM use, adverse events, efficacy (as HbA1c, time in range, time above and below range) and psychological outcomes evaluated with Diabetes Treatment Satisfaction Questionnaire (DTSQ), Glucose Monitoring Satisfaction Survey (GMSS), Hypoglycemia Fear Survey (HFS2), Diabetes Distress Scale (DDS).

Results

16 subjects (13 males, 48.8 ± 10.1 years, HbA1c 55.8 ± 7.9 mmol/mol, mean ± SD) completed the study. DG5 was used more than EVS [percentage of use 95.7 ± 3.6% vs 93.5 ± 4.3% (p = 0.02)]. MARD was better with EVS (12.2 ± 11.5% vs. 13.1 ± 14.7%, p< 0.001). No differences were found in HbA1c. While using EVS time spent in range increased and time spent in hyperglycemia decreased, but these data were not confirmed by analysis of retrofitted data based on SMBG values. EVS reduced perceived distress, without significant changes in other psychological outcomes.

Conclusions

CGM features may affect glycemic control and device acceptance.

中文翻译：

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植入式和经皮连续血糖监测系统：一项比较准确性、有效性和接受度的随机交叉试验

目的

比较植入式和经皮连续血糖监测 (CGM) 系统的准确性、有效性和接受度。

方法

在一项随机交叉试验中，我们比较了 12 周与 Eversense 植入式传感器 (EVS) 和 12 周与 Dexcom G5 经皮传感器 (DG5) 的准确性，评估为平均绝对相对差 (MARD) 与毛细血管葡萄糖 (SMBG)，时间使用糖尿病治疗满意度问卷 (DTSQ)、血糖监测满意度调查 (GMSS)、低血糖恐惧调查 (HFS2)、糖尿病评估 CGM 使用、不良事件、疗效（如 HbA1c、范围内时间、高于和低于范围的时间）和心理结果遇险量表 (DDS)。

结果

16 名受试者（13 名男性，48.8 ± 10.1 岁，HbA1c 55.8 ± 7.9 mmol/mol，平均值 ± SD）完成了研究。DG5 的使用超过 EVS [使用百分比 95.7 ± 3.6% vs 93.5 ± 4.3% ( p  = 0.02)]。EVS 的 MARD 效果更好（12.2 ± 11.5% 对 13.1 ± 14.7%，p < 0.001）。HbA1c 未发现差异。虽然使用 EVS 在范围内花费的时间增加，而在高血糖中花费的时间减少，但这些数据并未通过基于 SMBG 值的改进数据分析得到证实。EVS 减少了感知到的痛苦，而其他心理结果没有显着变化。

结论

CGM 功能可能会影响血糖控制和设备接受度。