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Randomized Controlled Trial
. 2022 Jan;45(1):115-124.
doi: 10.1007/s40618-021-01624-2. Epub 2021 Jul 1.

Implantable and transcutaneous continuous glucose monitoring system: a randomized cross over trial comparing accuracy, efficacy and acceptance

F Boscari  1 , M Vettoretti  2 , F Cavallin  3 , A M L Amato  1 , A Uliana  1 , V Vallone  1 , A Avogaro  1 , A Facchinetti  2 , D Bruttomesso  4
Affiliations
Randomized Controlled Trial

Implantable and transcutaneous continuous glucose monitoring system: a randomized cross over trial comparing accuracy, efficacy and acceptance

F Boscari et al. J Endocrinol Invest. 2022 Jan.

Abstract

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.

Keywords: Continuous glucose monitoring; Glycemic control; Implantable and transcutaneous sensors; Sensors acceptance; Sensors accuracy; Type 1 diabetes.

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Conflict of interest statement

DB, FB has received lecture fees from Abbott and Roche. Other authors declare no conflict of interest in connection with the submitted material.

Figures

Fig. 1
Fig. 1
Participant’s opinion about sensors
See this image and copyright information in PMC

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