Skip to main navigation menu Skip to main content Skip to site footer
##common.pageHeaderLogo.altText##

Original article

Vol. 154 No. 3 (2024)

Impact on diabetes control and patient-reported outcomes of a newer implantable continuous glucose monitoring system (Eversense® CGM System): a single-centre retro- and prospective observational study

DOI
https://doi.org/10.57187/s.3366
Cite this as:
Swiss Med Wkly. 2024;154:3366
Published
20.03.2024

Summary

AIMS OF THE STUDY: The Eversense® CGM System is the first and only continuous glucose monitoring system (CGMS) that uses a fully subcutaneous implanted sensor. This study aimed to evaluate effectiveness, safety and patient-reported outcomes in patients using the Eversense® CGM System in a realistic clinical setting, assessed at a single Swiss diabetes centre (Luzerner Kantonsspital) with prolonged follow-up.

METHODS: This was a prospective and retrospective observational study that included patients with type 1 diabetes mellitus in whom at least one Eversense® glucose sensor was implanted between 2017 and 2022. The primary endpoint was the change in HbA1c levels from the baseline (before implantation of the sensor) to 6 ± 2 and 12 ± 2 months and the last follow-up (newest available value) after implantation. The secondary outcome measures were the number of premature sensor breakdowns, adverse events related to the implantation procedure (infection, bleeding, difficulties with implantation or explantation) and patient-related outcomes (assessed with a questionnaire).

RESULTS: A total of 33 patients participated in this study. The median follow-up time was 50 (IQR 22.3–58.5) months. In total, 178 sensor implantations were performed. Valid HbA1c results were available for 26 participants. Compared to the baseline values, HbA1c levels at 6 and 12 months and the last follow-up changed by –0.25%, –0.45 and –0.2 (p = 0.278, 0.308 and 0.296, respectively). We recorded 16 (9%) premature sensor breakdowns, all occurring between 2019 and 2020. Apart from one late-onset infection and four complicated sensor removals, no major complications were assessed. The results of the questionnaire showed a subjective improvement in hypoglycaemia rates, a better perception of hypoglycaemia and the impression of better diabetes management. Common issues with the device reported by the patients were technical errors (connection problems) and problems with the removal procedure.

CONCLUSIONS: The use of the Eversense® CGM System resulted in changes in HbA1c of between –0.2% and –0.45%. The rate of premature sensor breakdown was low. Major complications following sensor implantation or removal were absent, apart from one case of infection and four cases of complicated removal. Patient-reported outcomes with the Eversense® CGM System showed a subjective positive impact on hypoglycaemia rates, greater confidence in managing hypoglycaemia and diabetes in general, and easy handling of the transmitter and mobile app. Technical issues must be considered but are nowadays, with the use of the newest sensor generation, very rare.

References

  1. Lachin JM, Genuth S, Cleary P, Davis MD, Nathan DM; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group. Retinopathy and nephropathy in patients with type 1 diabetes four years after a trial of intensive therapy. N Engl J Med. 2000 Feb;342(6):381–9. 10.1056/NEJM200002103420603 DOI: https://doi.org/10.1056/NEJM200002103420603
  2. Nathan DM, Cleary PA, Backlund JY, Genuth SM, Lachin JM, Orchard TJ, et al.; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med. 2005 Dec;353(25):2643–53. 10.1056/NEJMoa052187
  3. Chehregosha H, Khamseh ME, Malek M, Hosseinpanah F, Ismail-Beigi F. A View Beyond HbA1c: Role of Continuous Glucose Monitoring. Diabetes Ther. 2019 Jun;10(3):853–63. 10.1007/s13300-019-0619-1 DOI: https://doi.org/10.1007/s13300-019-0619-1
  4. Beck RW, Riddlesworth TD, Ruedy K, Ahmann A, Haller S, Kruger D, et al.; DIAMOND Study Group. Continuous Glucose Monitoring Versus Usual Care in Patients With Type 2 Diabetes Receiving Multiple Daily Insulin Injections: A Randomized Trial. Ann Intern Med. 2017 Sep;167(6):365–74. 10.7326/M16-2855 DOI: https://doi.org/10.7326/M16-2855
  5. Lind M, Polonsky W, Hirsch IB, Heise T, Bolinder J, Dahlqvist S, et al. Continuous Glucose Monitoring vs Conventional Therapy for Glycemic Control in Adults With Type 1 Diabetes Treated With Multiple Daily Insulin Injections: The GOLD Randomized Clinical Trial. JAMA. 2017 Jan;317(4):379–87. 10.1001/jama.2016.19976 DOI: https://doi.org/10.1001/jama.2016.19976
  6. Beck RW, Riddlesworth T, Ruedy K, Ahmann A, Bergenstal R, Haller S, et al.; DIAMOND Study Group. Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized Clinical Trial. JAMA. 2017 Jan;317(4):371–8. 10.1001/jama.2016.19975 DOI: https://doi.org/10.1001/jama.2016.19975
  7. Benkhadra K, Alahdab F, Tamhane S, Wang Z, Prokop LJ, Hirsch IB, et al. Real-time continuous glucose monitoring in type 1 diabetes: a systematic review and individual patient data meta-analysis. Clin Endocrinol (Oxf). 2017 Mar;86(3):354–60. 10.1111/cen.13290 DOI: https://doi.org/10.1111/cen.13290
  8. Battelino T, Conget I, Olsen B, Schütz-Fuhrmann I, Hommel E, Hoogma R, et al.; SWITCH Study Group. The use and efficacy of continuous glucose monitoring in type 1 diabetes treated with insulin pump therapy: a randomised controlled trial. Diabetologia. 2012 Dec;55(12):3155–62. 10.1007/s00125-012-2708-9 DOI: https://doi.org/10.1007/s00125-012-2708-9
  9. Christiansen MP, Klaff LJ, Brazg R, Chang AR, Levy CJ, Lam D, et al. A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II. Diabetes Technol Ther. 2018 Mar;20(3):197–206. 10.1089/dia.2017.0142 DOI: https://doi.org/10.1089/dia.2017.0142
  10. Christiansen MP, Klaff LJ, Bailey TS, Brazg R, Carlson G, Tweden KS. A Prospective Multicenter Evaluation of the Accuracy and Safety of an Implanted Continuous Glucose Sensor: the PRECISION Study. Diabetes Technol Ther. 2019 May;21(5):231–7. 10.1089/dia.2019.0020 DOI: https://doi.org/10.1089/dia.2019.0020
  11. Kropff J, Choudhary P, Neupane S, Barnard K, Bain SC, Kapitza C, 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 Jan;40(1):63–8. 10.2337/dc16-1525 DOI: https://doi.org/10.2337/dc16-1525
  12. EV-XL-Broschure-HCP_Deutsch_20220207.pdf [Internet]. [cited 2022 Oct 19]. Available from: https://www.ascensia-diabetes.ch/siteassets/eversense/asset-library/EV-XL-Broschure-HCP_Deutsch_20220207.pdf
  13. LBL-1402-50-101_Rev_D_Eversense_User_Guide_mmol_DE-1.pdf [Internet]. [cited 2022 Oct 19]. Available from: https://global.eversensediabetes.com/wp-content/uploads/LBL-1402-50-101_Rev_D_Eversense_User_Guide_mmol_DE-1.pdf
  14. Danne T, Nimri R, Battelino T, Bergenstal RM, Close KL, DeVries JH, et al. International Consensus on Use of Continuous Glucose Monitoring. Diabetes Care. 2017 Dec;40(12):1631–40. 10.2337/dc17-1600 DOI: https://doi.org/10.2337/dc17-1600
  15. Dicembrini I, Cosentino C, Monami M, Mannucci E, Pala L. Effects of real-time continuous glucose monitoring in type 1 diabetes: a meta-analysis of randomized controlled trials. Acta Diabetol. 2021 Apr;58(4):401–10. 10.1007/s00592-020-01589-3 DOI: https://doi.org/10.1007/s00592-020-01589-3
  16. Teo E, Hassan N, Tam W, Koh S. Effectiveness of continuous glucose monitoring in maintaining glycaemic control among people with type 1 diabetes mellitus: a systematic review of randomised controlled trials and meta-analysis. Diabetologia. 2022 Apr;65(4):604–19. 10.1007/s00125-021-05648-4 DOI: https://doi.org/10.1007/s00125-021-05648-4
  17. Irace C, Cutruzzolà A, Nuzzi A, Assaloni R, Brunato B, Pitocco D, et al. Clinical use of a 180-day implantable glucose sensor improves glycated haemoglobin and time in range in patients with type 1 diabetes. Diabetes Obes Metab. 2020 Jul;22(7):1056–61. 10.1111/dom.13993 DOI: https://doi.org/10.1111/dom.13993
  18. Renard E, Riveline JP, Hanaire H, Guerci B; on behalf of the investigators of France Adoption Clinical Trial. Reduction of clinically important low glucose excursions with a long-term implantable continuous glucose monitoring system in adults with type 1 diabetes prone to hypoglycaemia: the France Adoption Randomized Clinical Trial. Diabetes Obes Metab. 2022 May;24(5):859–67. 10.1111/dom.14644 DOI: https://doi.org/10.1111/dom.14644
  19. Garg SK, Liljenquist D, Bode B, Christiansen MP, Bailey TS, Brazg RL, et al. Evaluation of Accuracy and Safety of the Next-Generation Up to 180-Day Long-Term Implantable Eversense Continuous Glucose Monitoring System: the PROMISE Study. Diabetes Technol Ther. 2022 Feb;24(2):84–92. 10.1089/dia.2021.0182 DOI: https://doi.org/10.1089/dia.2021.0182