We compared the sensor performance of 3 commercially available GM systems. A total of 12 patients with type 1 diabetes were included in a single-centre, open-label study in which the sensor performance of the Abbott FreeStyle libre (Abbott), Dexcom G4 Platinum (Dexcom) and Medtronic MiniMed 640G (Medtronic) systems over 12 hours was compared during mimicked real-life conditions (meals, exercise, hypo-and hyperglycaemia). Sensor performance was determined by fulfilment of ISO 15197:2013 criteria, calculating mean absolute relative difference (MARD), and was also illustrated using Parkes error grid and Bland-Altman plots. Sensor performance during changes in metabolic variables (lactate, betahydroxybutyrate, glucagon, non-esterified-fatty-acids) was determined by Spearman's rank correlation coefficient testing. The systems fulfilled ISO 15197:2013 criteria by 73.2% (Abbott), 56.1% (Dexcom) and 52.0% (Medtronic). The MARDs AE standard deviation in the entire glycaemic range were 13.2% AE 10.9% (Abbott), 16.8% AE 12.3% (Dexcom) and 21.4% AE 17.6% (Medtronic), respectively. All sensors performed less accurately during hypoglycaemia and best during hyperglycaemia. We did not observe an influence of metabolic variables on sensor performance.
Skin permeability can be assessed by measuring the passive electrical properties of the skin, which enables correction of skin permeability variations. This allows reduction of experiment numbers in future pharmacokinetic and pharmacodynamic studies with human skin ex vivo and in vivo and leads to diminished study costs.
The aim of this study was to develop a single-port system that combines glucose monitoring and insulin infusion. In a preclinical proof-of-concept trial, the performance of the glucose measurement at the site of insulin infusion was assessed. Glucose levels were clamped from 40 to 250 mg/dL by intravenous glucose infusion and subcutaneous insulin infusion via the glucose sensor. Sensor-glucose values correlated well with reference blood-glucose values, despite infusion at the site of glucose measurement. The average median ARE value was 21.6 ± 5.7 % for sensors used for insulin infusion, 18.1 ± 5.8 % for sensors used for NaCl infusion and 19.2 ± 7.9 % for sensors without infusion. These preclinical in vivo results demonstrate that single-port glucose monitoring is feasible at the site of insulin infusion.
We present a novel single-port continuous glucose monitoring system that simultaneously performs continuous glucose monitoring in subcutaneous tissue and insulin infusion. The luminescence based glucose sensor is applied on commercial insulin infusion catheters and is read-out transcutaneously by an optical module attached to the skin. In-vitro and in-vivo evaluation results demonstrate a good proof of concept with median absolute relative error values in the range of 20%.
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