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

F Boscari, M Vettoretti, F Cavallin, A M L Amato, A Uliana, V Vallone, A Avogaro, A Facchinetti, D Bruttomesso
Author Information
  1. F Boscari: Department of Medicine, University of Padova, Via Giustiniani 2, 35128, Padova, Italy.
  2. M Vettoretti: Department of Information Engineering (DEI), University of Padova, Padova, Italy.
  3. F Cavallin: Independent Statistician, Solagna, Italy.
  4. A M L Amato: Department of Medicine, University of Padova, Via Giustiniani 2, 35128, Padova, Italy.
  5. A Uliana: Department of Medicine, University of Padova, Via Giustiniani 2, 35128, Padova, Italy.
  6. V Vallone: Department of Medicine, University of Padova, Via Giustiniani 2, 35128, Padova, Italy.
  7. A Avogaro: Department of Medicine, University of Padova, Via Giustiniani 2, 35128, Padova, Italy.
  8. A Facchinetti: Department of Information Engineering (DEI), University of Padova, Padova, Italy.
  9. D Bruttomesso: Department of Medicine, University of Padova, Via Giustiniani 2, 35128, Padova, Italy. daniela.bruttomesso@unipd.it. ORCID

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

References

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MeSH Term

Adult
Blood Glucose Self-Monitoring
Cross-Over Studies
Diabetes Mellitus, Type 1
Female
Glycated Hemoglobin
Glycemic Control
Humans
Implants, Experimental
Insulin
Insulin Infusion Systems
Italy
Male
Middle Aged
Patient Acceptance of Health Care
Reproducibility of Results
Sensitivity and Specificity
Treatment Outcome

Chemicals

Glycated Hemoglobin A
Insulin
hemoglobin A1c protein, human

Word Cloud

Created with Highcharts 10.0.0EVStimeaccuracyacceptancetranscutaneousglucoseefficacymonitoringCGMvsHbA1crangeimplantablecontinuousrandomizedtrial12 weekssensorDG5evaluatedMARDSMBGusepsychologicaloutcomesDiabetesSatisfactionSurvey13spentdatacontrolImplantableSensorsAIM:comparesystemsMETHODS:crossovercomparedEversenseDexcomG5termsMeanAbsoluteRelativeDifferencecapillaryadverseeventsTreatmentQuestionnaireDTSQGlucoseMonitoringGMSSHypoglycemiaFearHFS2DistressScaleDDSRESULTS:16subjectsmales488 ± 101 years558 ± 79 mmol/molmean ± SDcompletedstudyused[percentage957 ± 36%935 ± 43%p = 002]better122 ± 115%1 ± 147%p< 0001differencesfoundusingincreasedhyperglycemiadecreasedconfirmedanalysisretrofittedbasedvaluesreducedperceiveddistresswithoutsignificantchangesCONCLUSIONS:featuresmayaffectglycemicdevicesystem:crosscomparingContinuousGlycemicsensorsType1diabetes

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