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A pilot study in humans of microneedle sensor arrays for continuous glucose monitoring

Sanjiv Sharma Orcid Logo, Ahmed El-Laboudi, Monika Reddy, Narvada Jugnee, Sujan Sivasubramaniyam, Mohamed El Sharkawy, Pantelis Georgiou, Desmond Johnston, Nick Oliver, Anthony E. G. Cass

Analytical Methods, Volume: 10, Issue: 18, Pages: 2088 - 2095

Swansea University Author: Sanjiv Sharma Orcid Logo

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DOI (Published version): 10.1039/C8AY00264A

Abstract

Although subcutaneously implanted continuous glucose monitoring (CGM) devices have been shown to support diabetes self-management, their uptake remains low due to a combination of high manufacturing cost and limited accuracy and precision arising from their invasiveness. To address these points, min...

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Published in: Analytical Methods
ISSN: 1759-9660 1759-9679
Published: 2018
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URI: https://cronfa.swan.ac.uk/Record/cronfa39114
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spelling 2023-02-08T17:30:05.2580690 v2 39114 2018-03-21 A pilot study in humans of microneedle sensor arrays for continuous glucose monitoring b6b7506358522f607b171ec9c94757b7 0000-0003-3828-737X Sanjiv Sharma Sanjiv Sharma true false 2018-03-21 MEDE Although subcutaneously implanted continuous glucose monitoring (CGM) devices have been shown to support diabetes self-management, their uptake remains low due to a combination of high manufacturing cost and limited accuracy and precision arising from their invasiveness. To address these points, minimally invasive, a solid microneedle array-based sensor for continuous glucose monitoring is reported here. These intradermal solid microneedle CGM sensors are designed for low cost manufacturing. The tolerability and performance of these devices is demonstrated through clinical studies, both in healthy volunteers and participants with type 1 diabetes (T1D). The geometry of these solid microneedles allows them to penetrate dermal tissue without the need for an applicator. The outer surface of these solid microneedles are modified as glucose biosensors. The microneedles sit in the interstitial fluid of the skin compartment and monitor real-time changes in glucose concentration. Optical coherence tomography measurements revealed no major axial movement of the microneedles in the tissue. No significant adverse events were observed and low pain scores were reported when compared to catheter insertion, deeming it safe for clinical studies in T1D. These amperometric sensors also yielded currents that tracked venous blood glucose concentrations, showing a clinically acceptable correlation. Studies in people with T1D gave a mean absolute relative difference (MARD) of 9% (with respect to venous blood glucose) with over 94% of the data points in the A and B zones of the Clarke error grid. These findings provide baseline data for further device development and a larger clinical efficacy and acceptability study of this microneedle intradermal glucose sensor in T1D. Journal Article Analytical Methods 10 18 2088 2095 1759-9660 1759-9679 31 12 2018 2018-12-31 10.1039/C8AY00264A COLLEGE NANME Biomedical Engineering COLLEGE CODE MEDE Swansea University 2023-02-08T17:30:05.2580690 2018-03-21T10:23:47.2872190 Faculty of Science and Engineering School of Engineering and Applied Sciences - Biomedical Engineering Sanjiv Sharma 0000-0003-3828-737X 1 Ahmed El-Laboudi 2 Monika Reddy 3 Narvada Jugnee 4 Sujan Sivasubramaniyam 5 Mohamed El Sharkawy 6 Pantelis Georgiou 7 Desmond Johnston 8 Nick Oliver 9 Anthony E. G. Cass 10 0039114-21032018105201.pdf sharma2018.pdf 2018-03-21T10:52:01.1970000 Output 2854922 application/pdf Accepted Manuscript true 2019-03-21T00:00:00.0000000 true eng
title A pilot study in humans of microneedle sensor arrays for continuous glucose monitoring
spellingShingle A pilot study in humans of microneedle sensor arrays for continuous glucose monitoring
Sanjiv Sharma
title_short A pilot study in humans of microneedle sensor arrays for continuous glucose monitoring
title_full A pilot study in humans of microneedle sensor arrays for continuous glucose monitoring
title_fullStr A pilot study in humans of microneedle sensor arrays for continuous glucose monitoring
title_full_unstemmed A pilot study in humans of microneedle sensor arrays for continuous glucose monitoring
title_sort A pilot study in humans of microneedle sensor arrays for continuous glucose monitoring
author_id_str_mv b6b7506358522f607b171ec9c94757b7
author_id_fullname_str_mv b6b7506358522f607b171ec9c94757b7_***_Sanjiv Sharma
author Sanjiv Sharma
author2 Sanjiv Sharma
Ahmed El-Laboudi
Monika Reddy
Narvada Jugnee
Sujan Sivasubramaniyam
Mohamed El Sharkawy
Pantelis Georgiou
Desmond Johnston
Nick Oliver
Anthony E. G. Cass
format Journal article
container_title Analytical Methods
container_volume 10
container_issue 18
container_start_page 2088
publishDate 2018
institution Swansea University
issn 1759-9660
1759-9679
doi_str_mv 10.1039/C8AY00264A
college_str Faculty of Science and Engineering
hierarchytype
hierarchy_top_id facultyofscienceandengineering
hierarchy_top_title Faculty of Science and Engineering
hierarchy_parent_id facultyofscienceandengineering
hierarchy_parent_title Faculty of Science and Engineering
department_str School of Engineering and Applied Sciences - Biomedical Engineering{{{_:::_}}}Faculty of Science and Engineering{{{_:::_}}}School of Engineering and Applied Sciences - Biomedical Engineering
document_store_str 1
active_str 0
description Although subcutaneously implanted continuous glucose monitoring (CGM) devices have been shown to support diabetes self-management, their uptake remains low due to a combination of high manufacturing cost and limited accuracy and precision arising from their invasiveness. To address these points, minimally invasive, a solid microneedle array-based sensor for continuous glucose monitoring is reported here. These intradermal solid microneedle CGM sensors are designed for low cost manufacturing. The tolerability and performance of these devices is demonstrated through clinical studies, both in healthy volunteers and participants with type 1 diabetes (T1D). The geometry of these solid microneedles allows them to penetrate dermal tissue without the need for an applicator. The outer surface of these solid microneedles are modified as glucose biosensors. The microneedles sit in the interstitial fluid of the skin compartment and monitor real-time changes in glucose concentration. Optical coherence tomography measurements revealed no major axial movement of the microneedles in the tissue. No significant adverse events were observed and low pain scores were reported when compared to catheter insertion, deeming it safe for clinical studies in T1D. These amperometric sensors also yielded currents that tracked venous blood glucose concentrations, showing a clinically acceptable correlation. Studies in people with T1D gave a mean absolute relative difference (MARD) of 9% (with respect to venous blood glucose) with over 94% of the data points in the A and B zones of the Clarke error grid. These findings provide baseline data for further device development and a larger clinical efficacy and acceptability study of this microneedle intradermal glucose sensor in T1D.
published_date 2018-12-31T03:49:38Z
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