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Detailed Analysis of Insulin Absorption Variability and the Tissue Response to Continuous Subcutaneous Insulin Infusion Catheter Implantation in Swine.

Detailed Analysis of Insulin Absorption Variability and the Tissue Response to Continuous Subcutaneous Insulin Infusion Catheter Implantation in Swine.
Author Information (click to view)

Hauzenberger JR, Hipszer BR, Loeum C, McCue PA, DeStefano M, Torjman MC, Kaner MT, Dinesen AR, Chervoneva I, Pieber TR, Joseph JI,


Hauzenberger JR, Hipszer BR, Loeum C, McCue PA, DeStefano M, Torjman MC, Kaner MT, Dinesen AR, Chervoneva I, Pieber TR, Joseph JI, (click to view)

Hauzenberger JR, Hipszer BR, Loeum C, McCue PA, DeStefano M, Torjman MC, Kaner MT, Dinesen AR, Chervoneva I, Pieber TR, Joseph JI,

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Diabetes technology & therapeutics 2017 10 05() doi 10.1089/dia.2017.0175
Abstract
BACKGROUND
Worldwide, ∼1 million people manage their type 1 diabetes with an insulin pump and a continuous subcutaneous insulin infusion (CSII) catheter. Patients routinely insert a new catheter every 2-3 days due to increasing variability of insulin absorption over time. Catheter insertion and maintenance damage capillaries, lymphatics, cells, and connective tissue leading to an acute inflammatory response.

METHODS
We compared an investigational CSII catheter (IC) and a commercial CSII catheter (CC) regarding insulin absorption pharmacokinetics (PK) and tissue inflammation. The two different catheter designs were implanted into the subcutaneous tissue of six swine for 5 days. Insulin boluses were given on days 1, 3, and 5 of wear-time to assess PK. Tissue around catheters was excised and stained to visualize inflammation and morphological changes of adjacent tissue.

RESULTS
Insulin absorption was better when infused through a CC with highest Cmax and fastest tmax values on day 5 of catheter wear-time. Both catheter types produced high intra- and intersubject day-to-day insulin absorption variability. The IC caused significantly more tissue disruption and lead to irregular changes in tissue morphology. Both catheter types were surrounded by a layer of inflammatory tissue that varied in composition, thickness, and density over time. A catheter that was manually inserted by pushing a sharp tip through the skin caused more trauma and variability than a 90° Teflon cannula with automated insertion.

CONCLUSIONS
Insulin absorption variability could be attributed to the layer of inflammatory tissue, which may function as a mechanical barrier to insulin flow into adjacent vascular tissue. The impact of the acute inflammatory tissue response on insulin absorption has to be considered in future catheter designs. A catheter that was manually inserted by pushing a sharp tip through the skin caused more trauma and variability than a 90° Teflon cannula with automated insertion.

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