Clinical Evaluation of a Novel Insulin Immunosensor
Authors' conclusion
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.
Study context
- Population
- Adults with T1D after preprandial insulin injectioncompleted the study
- Participants
- 9 adults
- Comparison
- Insulin immunosensor vs laboratory insulin enzyme-linked immunosorbant assay (ELISA)
- Outcome
- Accuracy of the insulin immunosensor: concordance of change from baseline in insulin levels with ELISA
Methodological detailsfirst clinical evaluation, preliminary feasibility evaluation
- First clinical evaluation
- Preliminary feasibility evaluation
Performance
As reported in the abstract
Concordant paired immunosensor-reference values
| Test or model | Value | Concordant paired values vs ELISA |
|---|---|---|
| Immunosensor | 70% | 70% |
Immunosensor
Value70%
Concordant paired values vs ELISA70%
Original publication
Clinical Evaluation of a Novel Insulin Immunosensor. J Diabetes Sci Technol. Published 4 February 2022. doi:10.
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