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Performance of the Eversense versus the Free Style Libre Flash glucose monitor during exercise and normal daily activities in subjects with type 1 diabetes mellitus
  1. Marion Fokkert1,
  2. Peter R van Dijk2,3,
  3. Mireille A Edens4,
  4. Alberto Díez Hernández5,
  5. Robbert Slingerland1,
  6. Rijk Gans2,
  7. Elías Delgado Álvarez6,7,
  8. Henk Bilo3
  1. 1Department of Clinical Chemistry, Isala, Zwolle, NA, The Netherlands
  2. 2Internal Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands
  3. 3Diabetes Research Center, Isala, Zwolle, NA, The Netherlands
  4. 4Department Innovation and Science, Isala, Zwolle, NA, The Netherlands
  5. 5Sección de Endocrinología, Hospital del Bierzo, Ponferrada, Castilla y León, Spain
  6. 6Sección de Diabetes, Universidad de Oviedo, Oviedo, Asturias, Spain
  7. 7Sección de Diabetes, Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain
  1. Correspondence to Dr Peter R van Dijk; p.r.van.dijk{at}umcg.nl

Abstract

Introduction Accurate blood glucose measurements are important in persons with diabetes during normal daily activities (NDA), even more so during exercise. We aimed to investigate the performance of fluorescence sensor-based and glucose oxidase-based interstitial glucose measurement during (intensive) exercise and NDA.

Research design and methods Prospective, observational study in 23 persons with type 1 diabetes when mountain biking for 6 days, followed by 6 days of NDA. Readings of the Eversense (fluorescence-based continuous glucose monitoring (CGM); subcutaneously implanted) and of the Free Style Libre (FSL; glucose oxidase-based flash glucose monitoring (FGM); transcutaneously placed) were compared with capillary glucose levels (Free Style Libre Precision NeoPro strip (FSLCstrip)).

Results Mean average differences (MAD) and mean average relative differences (MARD) were significantly different when comparing exercise with NDA (reference FSLCstrip); Eversense MAD 25±19 vs 17±6 mg/dL (p<0.001); MARD 17±6 vs 13%±6% (p<0.01) and FSL MAD 32±17 vs 18±8 mg/dL (p<0.01); MARD 20±7 vs 12%±5% (p<0.001).

When analyzing the data according to the Integrated Continuous Glucose Monitoring Approvals (class II–510(K) guidelines), the overall performance of interstitial glucose readings within 20% of the FSLCstrip during exercise compared with NDA was 69% vs 81% for the Eversense and 59% vs 83% for the FSL, respectively. Within 15% of the FSLCstrip was 59% vs 70% for the Eversense and 46% vs 71% for the FSL.

Conclusions During exercise, both fluorescence and glucose oxidase-based interstitial glucose measurements (using Eversense and FSL sensors) were less accurate compared with measurements during NDA. Even when acknowledging the beneficial effects of CGM or FGM, users should be aware of the risk of diminished accuracy of interstitial glucose readings during (intensive) exercise.

  • blood glucose monitoring
  • exercise
  • continous blood glucose monitor(s)
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Footnotes

  • EDÁ and HB contributed equally.

  • Contributors MF wrote protocol, did the practical examination, researched data, wrote manuscript, contributed to discussion. PRvD researched data, contributed to discussion, reviewed/edited manuscript. MAE, RS and RG contributed to discussion, reviewed/edited the manuscript. ADH and EDÁ did the practical examination, contributed to discussion, reviewed/edited manuscript. HB co-wrote protocol, contributed to discussion, reviewed/edited manuscript.

  • Funding This study was an investigator initiated study. Funding was made available by de Bas van de Goor foundation and Eversense materials were made available by Roche. MF and HB are the guarantors for the presented work.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval This study was approved by the Medical Ethical committees in Spain (Hospital Universitario Central de Asturias; 163/18) and The Netherlands (Isala Hospital; NL66388.075.18/180603) and registered in the Dutch trial register (www.trialregister.nl number NL7133). All participants gave written informed consent prior to the start of the study.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available on reasonable request. Nine hundred seventy data sets are available from Eversense and FSL with FSLCstrip comparison in the exercise week, and, subsequently, 896 data sets available for the normal daily activity week 1 year after publication.