Modern insulin therapy aims to establish good glycemic control without relevant hypoglycaemia. Physiologic insulin secretion can best be mimicked by insulin pump therapy (CSII). The novel catheter featuring Lantern Technology is designed to ensure insulin flow if occlusion from bending, kinking or clogging occurs. The aim of the present study is to investigate clinical performance of the novel Lantern catheter with artificially clogged tip compared to standard infusion set.
This randomized, controlled, double-blind cross-over trial will enrol 20 adult patients with type 1 diabetes experienced in using CSII. The study comprises two 3-day home CSII treatment phases using: a) the artificially clogged Lantern catheter or b) standard infusion set. All participants will undergo both treatment phases. During home CSII treatment phases subjects will follow their regular lifestyle and diabetes management with CSII therapy. During home phase, continuous glucose monitoring (CGM), capillary glucose and ketone measurements will be performed regularly and data will be downloaded from the devices at the end of the study. Additionally, rescue carbs and rescue insulin doses administered via insulin pen will be recorded in a diary.
Infusion set performance of the novel Lantern catheter with artificially clogged tip will be assessed by CGM data, insulin requirements and adverse events such as occurrence of ketoacidosis, requirement of rescue carbohydrates or rescue insulin doses via pen.
It is expected that the Lantern catheter provides stable insulin delivery even if bending, kinking or clogging of cannula occurs as mimicked by artificially clogging the Lantern catheter.