Abstract
AimTo compare accuracy, efficacy and acceptance of implantable and transcutaneous continuous glucose monitoring (CGM) systems.MethodsIn 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).Results16 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.ConclusionsCGM features may affect glycemic control and device acceptance.
Highlights
Continuous glucose monitoring (CGM) improves glycemic control in subjects with type 1 diabetes (T1D), decreasing HbA1c and reducing hypoglycemic events [1,2,3].The ability of CGM systems to transmit data to the cloud, so that it can be stored, shared and remotely viewed by the patient and the healthcare provider, makes CGM suitable for virtual consultations
When accuracy was evaluated in different glucose ranges, Eversense implantable sensor (EVS) was more accurate than Dexcom G5 transcutaneous sensor (DG5) in the euglycemic range, while there was no difference in the hypo- and hyper-glycemic ranges (Table 2)
Both sensors had mean absolute relative difference (MARD) values higher than previously reported [17, 19]. This is not unexpected since previous studies were done in controlled clinical settings and using as reference venous glucose values rather than values obtained by Self-monitoring of blood glucose (SMBG)
Summary
The ability of CGM systems to transmit data to the cloud, so that it can be stored, shared and remotely viewed by the patient and the healthcare provider, makes CGM suitable for virtual consultations. CGM is still used less than expected, especially by adolescents [8]. Misuse may be connected with problems with reimbursement, physical discomfort, problems with sensor insertion and holding on the skin, concerns about the accuracy of data, interference with sports and daily activities, skin reactions [9]. To foster the use of CGM, devices with increased accuracy and portability have been produced, together with sensors more easy to apply. Some CGM have been approved for non-adjunctive use [10, 11]
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