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Device Insertion Versus Material: Drivers of Inflammation in Diabetes Device Interfaces.

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Minimizing insertion trauma and choosing biocompatible materials are key to improving automated insulin delivery (AID) systems. This research highlights how material choice and insertion technique impact inflammatory responses and device wear time.

Keywords:
automated insulin delivery (AID)biomaterialcontinuous glucose monitoring (CGM) sensorforeign body responseinsulin infusion set (IIS)

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Area of Science:

  • Biomaterials Science
  • Immunology
  • Medical Device Engineering

Background:

  • Automated insulin delivery (AID) systems are hindered by short insulin infusion set (IIS) wear times (2-3 days), contrasting with longer continuous glucose monitoring (CGM) sensor lifespans (14 days).
  • Infusion set failure compromises AID reliability and patient adherence.
  • Understanding the inflammatory responses to IIS implantation is crucial for improving AID system performance.

Purpose of the Study:

  • To investigate the roles of insertion trauma and biomaterial composition in acute inflammatory responses to insulin infusion sets.
  • To compare the biocompatibility of different infusion set materials and CGM sensors.
  • To identify strategies for prolonging the wear time of devices used in AID systems.

Main Methods:

  • Evaluated three commercial CGM sensors and two Teflon-based IIS catheters in swine and mouse models.
  • Assessed neutrophil extracellular trap (NET) formation in swine tissue one day post-implantation.
  • Analyzed immune cell infiltration and cytokine expression in murine air pouch models at 1 and 3 days post-implantation.

Main Results:

  • Neutrophil extracellular traps (NETs) were present at all insertion sites, indicating insertion trauma as the primary trigger for early NET formation.
  • Teflon catheters induced a prolonged inflammatory response, including increased macrophages, mast cells, and TNF-α and KC/GRO levels.
  • Polyurethane-based sensors demonstrated minimal immune activation, suggesting superior biocompatibility compared to Teflon.

Conclusions:

  • Minimizing insertion trauma is critical for reducing acute inflammatory responses.
  • Selecting biocompatible materials, such as polyurethane, can enhance device-tissue integration and prolong wear time.
  • Optimizing material selection and insertion techniques can significantly improve AID system reliability and patient outcomes.