Vol 8, No 6 (2019)
Other materials agreed with the Editors
Published online: 2020-01-23

open access

Page views 1352
Article views/downloads 1132
Get Citation

Connect on Social Media

Connect on Social Media

Experts opinion: implantable continuous glucose monitoring system — innovation in the management of diabetes

Agnieszka Szadkowska1, Dorota Zozulińska-Ziółkiewicz2, Mieczysław Walczak3, Katarzyna Cyganek4, Bogumił Wolnik5, Andrzej Gawrecki2, Małgorzata Myśliwiec6
Clin Diabetol 2019;8(6):318-328.

Abstract

Continuous glucose monitoring (CGM) systems have revolutionized the treatment and monitoring of diabetes. These devices are recommended for diabetic patients treated with insulin, especially with recurring episodes of hypoglycemia or large circadian variation of glucose levels. CGM allows more effective adjustment of insulin doses to blood glucose trends, resulting in better metabolic control: more time spend in glucose target range, lower time spend in hypoglycemic range, lower glucose variability and improved quality of life of patients and their family members. Real time CGM provides patients not only with continuous information on glucose levels but also alerts for hypo- or hyperglycemic events.

Traditional transcutaneous CGM have some limitations, which can be resolved by the system with an implantable sensor. The Eversense CGM is the only long-term implantable rtCGM. The subcutaneous implantation procedure has proved to be simple and uncomplicated. This CGM system can be recommended in particular for patients who, due to their profession and sports discipline, cannot or do not want to use traditional transcutaneous sensors. Further groups are patients with skin complications associated with the use of traditional sensors, people who perceive frequent sensor replacement as a burden or would benefit from on-body vibration alerts. The studies showed that the patients were satisfied with Eversense, and the majority used it several times after the study ended. The main reason for resigning from the next implantation was cost of the device.

Article available in PDF format

View PDF Download PDF file

References

  1. Cho NH, Shaw JE, Karuranga S, et al. IDF Diabetes Atlas: Global estimates of diabetes prevalence for 2017 and projections for 2045. Diabetes Res Clin Pract. 2018; 138: 271–281.
  2. Papatheodorou K, Banach M, Bekiari E, et al. Complications of Diabetes 2017. J Diabetes Res. 2018; 2018: 3086167.
  3. Sherwani SI, Khan HA, Ekhzaimy A, et al. Significance of HbA1c Test in Diagnosis and Prognosis of Diabetic Patients. Biomark Insights. 2016; 11: 95–104.
  4. Araszkiewicz A, Bandurska-Stankiewicz E, Budzyński A, et al. 2019 Guidelines on the management of diabetic patients. A position of Diabetes Poland. Clinical Diabetology. 2019; 8(1): 1–95.
  5. Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Interventions and Complications (EDIC) Study Research Group. Mortality in Type 1 Diabetes in the DCCT/EDIC Versus the General Population. Diabetes Care. 2016; 39(8): 1378–1383.
  6. Škrha J, Šoupal J, Škrha J, et al. Glucose variability, HbA1c and microvascular complications. Rev Endocr Metab Disord. 2016; 17(1): 103–110.
  7. Shafiee G, Mohajeri-Tehrani M, Pajouhi M, et al. The importance of hypoglycemia in diabetic patients. J Diabetes Metab Disord. 2012; 11(1): 17.
  8. Kalra S, Mukherjee JJ, Venkataraman S, et al. Hypoglycemia: The neglected complication. Indian J Endocrinol Metab. 2013; 17(5): 819–834.
  9. Yun JS, Park YM, Han K, et al. Severe hypoglycemia and cardiovascular or all-cause mortality in patients with type 2 diabetes. Diabetes Metab J. 2016; 40(3): 202–210.
  10. Czupryniak L, Barkai L, Bolgarska S, et al. Self-monitoring of blood glucose in diabetes: from evidence to clinical reality in Central and Eastern Europe — recommendations from the international Central-Eastern European expert group. Diabetes Technol Ther. 2014; 16(7): 460–475.
  11. Klonoff DC, Ahn D, Drincic A. Continuous glucose monitoring: A review of the technology and clinical use. Diabetes Res Clin Pract. 2017; 133: 178–192.
  12. Klimek M, Tulwin T. Continuous glucose monitoring: review of promising technologies. MATEC Web of Conferences. 2019; 252: 02012.
  13. Edelman SV, Argento NB, Pettus J, et al. Clinical implications of real-time and intermittently scanned continuous glucose monitoring. Diabetes Care. 2018; 41(11): 2265–2274.
  14. Heinemann L, Freckmann G. CGM versus FGM; or, continuous glucose monitoring is not flash glucose monitoring. J Diabetes Sci Technol. 2015; 9(5): 947–950.
  15. Mancini G, Berioli MG, Santi E, et al. Flash glucose monitoring: a review of the literature with a special focus on type 1 diabetes. Nutrients. 2018; 10(8).
  16. Jafri R, Balliro C, El-Khatib F, et al. et al.. A Three-Way Accuracy Comparison of the Dexcom G5, Abbott Freestyle Libre Pro, and SenseonicsEversense CGM Devices in an Outpatient Study of Subjects with Type 1 Diabetes. Diabetes Jul. 2018; 67(Suppl 1): 14–OR.
  17. Petrie JR, Peters AL, Bergenstal RM, et al. Improving the clinical value and utility of CGM systems: issues and recommendations : A joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group. Diabetologia. 2017; 60(12): 2319–2328.
  18. Szypowska A, Ramotowska A, Dzygalo K, et al. Beneficial effect of real-time continuous glucose monitoring system on glycemic control in type 1 diabetic patients: systematic review and meta-analysis of randomized trials. Eur J Endocrinol. 2012; 166(4): 567–574.
  19. Rodbard D. Continuous glucose monitoring: a review of successes, challenges, and opportunities. Diabetes Technol Ther. 2016; 18 Suppl 2: S3–SS13.
  20. Deiss D, Szadkowska A, Gordon D, et al. Clinical Practice Recommendations on the Routine Use of Eversense, the First Long-Term Implantable Continuous Glucose Monitoring System. Diabetes Technol Ther. 2019; 21(5): 254–264.
  21. Battelino T, Danne T, Bergenstal RM, et al. Clinical targets for continuous glucose monitoring data interpretation: recommendations from the international consensus on time in range. Diabetes Care. 2019; 42(8): 1593–1603.
  22. https://www.eversensediabetes.com/.
  23. Kropff J, Choudhary P, Neupane S, et al. Accuracy and Longevity of an Implantable Continuous Glucose Sensor in the PRECISE Study: A 180-Day, Prospective, Multicenter, Pivotal Trial. Diabetes Care. 2017; 40(1): 63–68.
  24. Barnard KD, Kropff J, Choudhary P, et al. Acceptability of implantable continuous glucose monitoring sensor. J Diabetes Sci Technol. 2018; 12(3): 634–638.
  25. Christiansen MP, Klaff LJ, Brazg R, et al. A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II. Diabetes Technol Ther. 2018; 20(3): 197–206.
  26. Aronson R, Abitbol A, Tweden KS. First assessment of the performance of an implantable continuous glucose monitoring system through 180 days in a primarily adolescent population with type 1 diabetes. Diabetes Obes Metab. 2019; 21(7): 1689–1694.
  27. Study of patients' opinion on Eversense system which allows continuous glucose monitoring (CGM). Biostat, final report, Warsaw, 08.2018 (data not published).
  28. Heinemann L, DeVries JH. Reimbursement for continuous glucose monitoring. Diabetes Technol Ther. 2016; 18 Suppl 2: S248–S252.
  29. Graham C. Continuous glucose monitoring and global reimbursement: an update. Diabetes Technol Ther. 2017; 19(S3): S60–S66.
  30. Regulation of the Minister of Health from January 18, 2018. Dz.U. 2018 poz. 281.
  31. Regulation of the Minister of Health from September 26, 2019. Dz.U. 2019 poz. 1899.