Assessment of Infusion Set Survival of the Newly Developed Lantern Catheter in Type 1 Diabetes by Glucose CLA Technique

Abstract

The catheter-tissue interface is the bottle neck of insulin pump therapy (CSII). Currently infusion sets shall be changed every 2-3 days to avoid lipohypertrophy, fluctuations in insulin absorption and occlusion. Patients would prefer an extended wear time if stable insulin absorption could be achieved. The novel catheter featuring Lantern Technology shall allow more stable insulin delivery via slots in the shaft of the soft cannula even if kinking or clotting occurs. The aim of the present study was to investigate clinical performance of the coated Lantern catheter in 16 patients with type 1 diabetes using CSII over a period of up to 7 days. A combined design comprising inpatient (euglycemic clamps on days 1, 4 and 7) and outpatient phases (insulin pump therapy over 7 days) is chosen to allow assessment of performance and survival time of the Lantern catheter. 16 c-peptide negative patients (age 44.2 ± 15.4 years, BMI 24.5 ± 2.3 kg/m2, HbA1c 55 ± 8 mmol/mol, diabetes duration 20 ± 9 years) completed the 7-day study period. Geometric means of maximum glucose infusion rates (GIR) were similar for days 1, 4 and 7 (6.1 ± 1.5, 7.2 ± 1.3, 5.8 ± 1.4; p=0.14). Time to reach 50% of the maximum GIR were similar over time (31.5 ± 1.6 minutes vs. 29.3 ± 1.3 minutes vs. 27.3 ± 1.3 minutes for days 1, 4 and 7 respectively; p=0.51). Area under the log-transformed GIR curve did not significantly differ for the first 2 hours between days (343.7 ± 1.5 vs. 421.3 ± 1.6 vs. 350.6 ± 1.8; p=0.14; days 1, 4 and 7, respectively); however, there was a trend towards reduced area under the GIR curve over 8 hours over time (874.2 ± 1.4 vs. 744.5 ± 1.7 vs. 509.2 ± 2.0; days 1, 4 and 7, respectively; p<0.05). During outpatient care no severe hypoglycemic event or ketoacidosis occurred. The novel Lantern catheter could be safely used over an extended wear-time of 7 days. There was a trend towards reduced insulin action over time. The findings need to be confirmed in a larger scale trial under routine conditions. Disclosure A. Ajsic: None. M.C. Krasser: None. R. Juliussen: Employee; Self; ConvaTec Inc. P.K. Schøndorff: Employee; Spouse/Partner; ConvaTec Inc.. M. Heschel: None. T. Pöttler: None. D. Schwarzenbacher: None. T. Augustin: None. T.R. Pieber: Consultant; Self; Arecor, AstraZeneca, Eli Lilly and Company, Novo Nordisk A/S, Sanofi. Employee; Self; CBmed. Research Support; Self; Novo Nordisk A/S, AstraZeneca. G. Treiber: None. J.K. Mader: Speaker's Bureau; Self; Roche Diabetes Care Health and Digital Solutions, Novo Nordisk A/S. Advisory Panel; Self; Eli Lilly and Company. Consultant; Self; Becton, Dickinson and Company. Speaker's Bureau; Self; Sanofi. Research Support; Self; ConvaTec Inc., Menarini Group. Speaker's Bureau; Self; Medtronic. Research Support; Self; Novo Nordisk A/S, Sanofi.