Impact of Infusion Set Materials and Designs on the Subcutaneous Response in People With Diabetes: A Rapid Review of the Literature.

Abstract

Insulin infusion sets (IISs) are an integral and intricate part of continuous subcutaneous insulin infusion for subjects with type 1 diabetes, infusing insulin from pump to the subcutaneous space. Insulin infusion sets interface with the skin surface, the dermis, and the subcutaneous space and may be the cause of infusion failure due to biological events or mechanical problems. Novel IISs with extended wear time and anti-inflammatory properties to mitigate these issues are described in the literature although material-tissue interactions are poorly understood. This rapid review focuses on the impact of IIS materials and designs on the subcutaneous response in people with diabetes and includes literature identified in PubMed, Embase, and Cochrane databases. Twenty-one studies were identified for qualitative synthesis that encompassed a limited and heterogenic body of evidence including 10 clinical reports, six reviews, one case report, two abstracts, and two communications. Two clinical reports were randomized crossover studies. Reports on materials mostly compared steel versus polytetrafluoroethylene (Teflon) cannulas and suggested no substantial difference in tissue response to these materials. Reports on designs focused mostly on the angle of cannula insertion. To drive and improve research on extended wear and nonimmunogenic IISs, future studies should focus on material-tissue interaction as dedicated outcome measures, quantified with punch biopsy and imaging techniques such as ultrasound, optical coherence tomography, and confocal reflectance microscopy. Original studies are required to further a field too young for a systematic meta-analysis.