Clinical Trials Study
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Aug 6, 2022; 10(22): 7794-7807
Published online Aug 6, 2022. doi: 10.12998/wjcc.v10.i22.7794
Performance of Dexcom G5 and FreeStyle Libre sensors tested simultaneously in people with type 1 or 2 diabetes and advanced chronic kidney disease
Arndís Finna Ólafsdóttir, Mervi Andelin, Aso Saeed, Sheyda Sofizadeh, Hussein Hamoodi, Per-Anders Jansson, Marcus Lind
Arndís Finna Ólafsdóttir, Mervi Andelin, Sheyda Sofizadeh, Marcus Lind, Department of Medicine, NU-Hospital Group, Uddevalla, Sweden
Arndís Finna Ólafsdóttir, Marcus Lind, Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Göteborg, Sweden
Aso Saeed, Department of Nephrology, Gothenburg University, Sahlgrenska Academy, Institute Internal Medicine, Göteborg, Sweden
Hussein Hamoodi, Statistiska Konsultgruppen, Göteborg, Sweden
Per-Anders Jansson, Wallenberg Laboratory, Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Göteborg, Sweden
Author contributions: Ólafsdóttir AF, Andelin M, and Lind M contributed to the design of this study; Ólafsdóttir AF drafted the manuscript; All authors contributed to the analysis and interpretation of the data, revised the manuscript, and gave final approval of the version to be published.
Institutional review board statement: The protocol was approved by the regional ethical review board of Gothenburg.
Clinical trial registration statement: The trial is registered on clinicaltrial.gov NCT, No. 03378271.
Conflict-of-interest statement: AFO has done consultancy work for Nordic Infucare. SS has done consultancy work for Novo Nordisk, Bayer, Sanofi, and Boehringer Ingelheim ML has received research grants from Ely Lilly and Novonordisk outside the submitted work and personal fees from Astra Zeneca, Boehringer Ingelheim, DexCom, Eli Lilly, MSD and Novonordisk, all outside the current work. AM, AS, HH, and PAJ have no conflict of interest to report.
Data sharing statement: All data are available from the corresponding author (AFO) upon a reasonable request.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Arndís Finna Ólafsdóttir, RN, Nurse, Department of Medicine, NU-Hospital Group, Fjällvägen 9, Uddevalla, Sweden. finna.olafsdottir@vgregion.se
Received: January 27, 2022
Peer-review started: January 27, 2022
First decision: March 11, 2022
Revised: April 4, 2022
Accepted: June 3, 2022
Article in press: June 3, 2022
Published online: August 6, 2022
Processing time: 175 Days and 16.9 Hours
Abstract
BACKGROUND

Advanced chronic kidney disease (CKD) is a common complication for people with type 1 and 2 diabetes and can often lead to glucose instability. Continuous glucose monitoring (CGM) helps users monitor and stabilize their glucose levels. To date, CGM and intermittent scanning CGM are only approved for people with diabetes but not for those with advanced CKD.

AIM

To compare the performance of Dexcom G5 and FreeStyle Libre sensors in adults with type 1 or 2 diabetes and advanced CKD.

METHODS

This was a non-randomized clinical trial that took place in two outpatient clinics in western Sweden. All patients with type 1 or 2 diabetes and an estimated glomerular filtration rate (eGFR) of < 30 mL/min per 1.73 m2 were invited to participate. Forty patients (full analysis set = 33) carried the Dexcom G5 sensor for 7 d and FreeStyle Libre sensor for 14 d simultaneously. For referencing capillary blood glucose (SMBG) was measured with a high accuracy glucose meter (HemoCue®) during the study period. At the end of the study, all patients were asked to answer a questionnaire on their experience using the sensors.

RESULTS

The mean age was 64.1 (range 41-77) years, hemoglobin A1c was 7.0% [standard deviation (SD) 3.2], and diabetes duration was 28.5 (SD 14.7) years. A total of 27.5% of the study population was on hemodialysis and 22.5% on peritoneal dialysis. The mean absolute relative difference for Dexcom G5 vs SMBG was significantly lower than that for FreeStyle Libre vs SMBG [15.2% (SD 12.2) vs 20.9% (SD 8.6)], with a mean difference of 5.72 [95% confidence interval (CI): 2.11-9.32; P = 0.0036]. The mean absolute difference was also significantly lower for Dexcom G5 than for FreeStyle Libre, 1.21 mmol/L (SD 0.78) and 1.76 mmol/L (SD 0.78), with a mean diffrenec of 0.55 (95%CI: 0.27-0.83; P = 0.0004).The mean difference (MD) was -0.107 mmol/L and -1.10 mmol/L (P = 0.0002), respectively. In all, 66% of FreeStyle Libre values were in the no risk zone on the surveillance error grid compared to 82% of Dexcom G5 values.

CONCLUSION

Dexcom G5 produces more accurate sensor values than FreeStyle Libre in people with diabetes and advanced CKD and is likely safe to be used by those with advanced CKD.

Keywords: Type 1 diabetes, Type 2 diabetes, Chronic kidney disease, Continuous glucose monitoring, Accuracy, Mean absolute relative difference

Core Tip: This study bridges a needed gap within the diabetes device area for people with diabetes and advanced chronic kidney disease and was done in a home setting for analyses as close to real life as possible. The study found that Dexcom G5 showed greater accuracy both in relation to the mean absolute relative difference and on a surveillance error grid, but participants rated their user experience for FreeStyle Libre higher but rated no difference in feeling safe.