Laboratory and Benchtop Performance of a Mealtime Insulin-Delivery System.

Autor:	Dreon DM; 1 Calibra Medical, a Johnson & Johnson Company, Wayne, PA, USA., Hannon TM; 1 Calibra Medical, a Johnson & Johnson Company, Wayne, PA, USA., Cross B; 1 Calibra Medical, a Johnson & Johnson Company, Wayne, PA, USA., Carter BJ; 1 Calibra Medical, a Johnson & Johnson Company, Wayne, PA, USA., Mercer NS; 1 Calibra Medical, a Johnson & Johnson Company, Wayne, PA, USA., Nguyen JH; 1 Calibra Medical, a Johnson & Johnson Company, Wayne, PA, USA., Tran A; 1 Calibra Medical, a Johnson & Johnson Company, Wayne, PA, USA., Melendez PA; 1 Calibra Medical, a Johnson & Johnson Company, Wayne, PA, USA., Morales N; 2 LifeScan, LLC, a Johnson & Johnson Company, Wayne, PA, USA., Nelson JE; 1 Calibra Medical, a Johnson & Johnson Company, Wayne, PA, USA., Tan MH; 3 Division of Metabolism, Endocrinology and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
Jazyk:	angličtina
Zdroj:	Journal of diabetes science and technology [J Diabetes Sci Technol] 2018 Jul; Vol. 12 (4), pp. 817-827. Date of Electronic Publication: 2018 Feb 28.
DOI:	10.1177/1932296818760633
Abstrakt:	Background: A basal bolus insulin regimen requires multiple daily insulin injections, which might discourage patient adherence. As a potential solution, a mealtime insulin-delivery system-a 3-day wearable bolus-only patch-was designed to manually administer mealtime insulin discreetly by actuating buttons through clothing, without the need for multiple needle sticks. Method: Extensive functional testing of the patch included dose accuracy (from initial fill of the device to empty), pressure-vacuum leak testing, last-dose lockout and occlusion detection (safety alert features that lock the dosing buttons when no insulin is delivered), assessments of insulin drug stability, toxicological risk (including chemical testing), and system biocompatibility. Results: Dosing accuracy was 2 units ±10% (with U-100 insulin) over a range of environmental conditions, with ≥95% reliability and confidence. The fluid seal performance and the safety alert features performed with ≥95% reliability and ≥95% confidence. The system met acceptable standards for insulin (U-100 lispro and aspart) stability for its intended 3-day use, in addition to the operational requirements. The toxicological risk assessment and demonstrated biocompatibility suggested that the patch is safe for human use. Conclusions: Benchtop performance showed that the bolus-only patch is a safe, accurate, and reliable device for mealtime insulin delivery.
Databáze:	MEDLINE
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