Background:The estimation of available active insulin remains a limitation of automated insulin delivery systems. Currently, insulin pumps calculate active insulin using mathematical decay curves, while quantitative measurements of insulin would explicitly provide person-specific PK insulin dynamics to assess remaining active insulin more accurately, permitting more effective glucose control. Methods:We performed the first clinical evaluation of an insulin immunosensor chip, providing near real-time measurements of insulin levels. In this study, we sought to determine the accuracy of the novel insulin sensor and assess its therapeutic risk and benefit by presenting a new tool developed to indicate the potential therapeutic consequences arising from inaccurate insulin measurements. Results:Nine adult participants with type-1 diabetes completed the study. The change from baseline in immunosensor-measured insulin levels was compared with values obtained by standard enzyme-linked immunosorbant assay (ELISA) after preprandial injection of insulin. The point-of-care quantification of insulin levels revealed similar temporal trends as those from the laboratory insulin ELISA. The results showed that 70% of the paired immunosensor-reference values were concordant, which suggests that the patient could take action safely based on insulin concentration obtained by the novel sensor. Conclusions:This proposed technology and preliminary feasibility evaluation show encouraging results for near real-time evaluation of insulin levels, with the potential to improve diabetes management. Real-time measurements of insulin provide person-specific insulin dynamics that could be used to make more informed decisions regarding insulin dosing, thus helping to prevent hypoglycemia and improve diabetes outcomes.

Clinical Evaluation of a Novel Insulin Immunosensor / Aiello, Eleonora M.; Pinsker, Jordan E.; Vargas, Eva; Teymourian, Hazhir; Tehrani, Farshad; Church, Mei Mei; Laffel, Lori M.; Doyle, Francis J.; Patti, Mary-Elizabeth; Wang, Joseph; Dassau, Eyal. - In: JOURNAL OF DIABETES SCIENCE AND TECHNOLOGY. - ISSN 1932-2968. - 17:4(2023), pp. 1038-1048. [10.1177/19322968221074406]

Clinical Evaluation of a Novel Insulin Immunosensor

Aiello, Eleonora M.
Primo
;
2023-01-01

Abstract

Background:The estimation of available active insulin remains a limitation of automated insulin delivery systems. Currently, insulin pumps calculate active insulin using mathematical decay curves, while quantitative measurements of insulin would explicitly provide person-specific PK insulin dynamics to assess remaining active insulin more accurately, permitting more effective glucose control. Methods:We performed the first clinical evaluation of an insulin immunosensor chip, providing near real-time measurements of insulin levels. In this study, we sought to determine the accuracy of the novel insulin sensor and assess its therapeutic risk and benefit by presenting a new tool developed to indicate the potential therapeutic consequences arising from inaccurate insulin measurements. Results:Nine adult participants with type-1 diabetes completed the study. The change from baseline in immunosensor-measured insulin levels was compared with values obtained by standard enzyme-linked immunosorbant assay (ELISA) after preprandial injection of insulin. The point-of-care quantification of insulin levels revealed similar temporal trends as those from the laboratory insulin ELISA. The results showed that 70% of the paired immunosensor-reference values were concordant, which suggests that the patient could take action safely based on insulin concentration obtained by the novel sensor. Conclusions:This proposed technology and preliminary feasibility evaluation show encouraging results for near real-time evaluation of insulin levels, with the potential to improve diabetes management. Real-time measurements of insulin provide person-specific insulin dynamics that could be used to make more informed decisions regarding insulin dosing, thus helping to prevent hypoglycemia and improve diabetes outcomes.
2023
4
Aiello, Eleonora M.; Pinsker, Jordan E.; Vargas, Eva; Teymourian, Hazhir; Tehrani, Farshad; Church, Mei Mei; Laffel, Lori M.; Doyle, Francis J.; Patti...espandi
Clinical Evaluation of a Novel Insulin Immunosensor / Aiello, Eleonora M.; Pinsker, Jordan E.; Vargas, Eva; Teymourian, Hazhir; Tehrani, Farshad; Church, Mei Mei; Laffel, Lori M.; Doyle, Francis J.; Patti, Mary-Elizabeth; Wang, Joseph; Dassau, Eyal. - In: JOURNAL OF DIABETES SCIENCE AND TECHNOLOGY. - ISSN 1932-2968. - 17:4(2023), pp. 1038-1048. [10.1177/19322968221074406]
File in questo prodotto:
File Dimensione Formato  
aiello-et-al-2022-clinical-evaluation-of-a-novel-insulin-immunosensor.pdf

Solo gestori archivio

Tipologia: Versione editoriale (Publisher’s layout)
Licenza: Tutti i diritti riservati (All rights reserved)
Dimensione 1.78 MB
Formato Adobe PDF
1.78 MB Adobe PDF   Visualizza/Apri

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11572/402000
Citazioni
  • ???jsp.display-item.citation.pmc??? 1
  • Scopus 4
  • ???jsp.display-item.citation.isi??? 3
social impact