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Gewählte Publikation:

Krasser, M.
Assessment of Infusion Set Survival of a Novel Insulin Infusion Catheter in Type 1 Diabetes by glucose clamp technique (a Pilot Study)
Humanmedizin; [ Diplomarbeit ] Graz Medical University; 2019. pp. 62 [OPEN ACCESS]
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Autor*innen der Med Uni Graz:
Betreuer*innen:
Mader Julia
Samonigg Judith
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Abstract:
Objective To evaluate the efficacy and safety of the new coated subcutaneous infusion set with Lantern Technology over seven days of wear and to determine whether the novel cannula design facilitates consistent insulin flow over extended wear time. Method 16 type 1 diabetes patients (age 44.2±15.4 years, BMI 24.5±2.3 kg/m2, A1C 55±8 mmol/mol, diabetes duration 20±9 years) underwent a 7-day continuous subcutaneous insulin infusion (CSII) treatment combined with flash glucose monitoring (FGM). The patients participated in three 8h euglycemic clamp experiments (study days 1, 4, and 7) and spent the days between the experiments (study days 3, 4, 5, and 6) at home routinely managing diabetes with CSII and FGM. Result The catheter survival rate was 100%. There was no incidence of severe hypoglycemia or ketoacidosis during the study period. The percentage of time within the target range (70-180mg/dL) was similar over 24h (d2: 60.8 ± 15.0 vs. d3: 66.5 ± 18.7 vs. d5: 55.8 ± 21.2 vs. d6: 53.5 ± 25.2%; mean ± SE). Time to reach 50% of the maximum glucose infusion rate (GIR) was comparable between clamps (geo. mean 31.5±1.6 [20.0-49.49] vs. 29.3±1.3 [22.3-38.6] vs. 27.3±1.3 [20.4-36.7] min; p=0.51). The log-transformed AUCGIR (area under the curve of GIR) did not significantly differ for the first 2h of the clamp (geo. mean 343.7 [228.6-516.7] vs. 421.3 [271.4-654.1] vs. 350.6 [200.3-613.6] mg/kg; p=0.14). Time to GIRMAX was reduced with increasing wear time (median 137.50 [72.5-147.5] vs. 50.0 [40.0-80.0] vs. 45.0 [35.0-62.5] min; p<0.002). However, there was a reduction in AUCGIR over 8h over time (geo. mean 874.2 [620.0-1232.7] vs. 744.5 [451.4-1228.0] vs. 509.2 [257.2-1008.2]mg/kg; p<0.05). Conclusion The coated infusion set with Lantern Technology could be safely used during extended wear. There was a shift of GIRMAX profile towards faster onset and reduced insulin action over time. The findings need to be confirmed in a larger scale trial under routine conditions. The study was funded by ConvaTec.

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