A New Feed Back For Monitoring Insulin Therapy? (First Experimental and Clinical Tests)

Abstract

The treatment of glucose metabolism disorders in critically ill or in diabetic patients remains sometimes arduous because the serum glucose concentration does not reflect in real time the tissues metabolic situation. We hypothesized that the difference Dt between core (Tc) and subcutaneous (Ts) temperatures of the body can reflect the tissues energy balance (which glucose metabolism ensures for 70%) and hence be used to monitor glucose metabolism. A device – ADD-CIT - was elaborated and patented. It includes a thin rectal catheter with two temperature captors at a distance of 4.5 cm, a temperature analyser, a computer which commands an insulin pump according to an algorithm linked with the recorded evolution of Dt values. The results of its first tests are presented here. The device technical liability was tested in thermostat according to standard methods. The feasibility of temperature registration was verified in animal experiments on rats. From 1998 till 2012, the device was tested in13 healthy volunteers and 58 diabetic patients type 1 with a more than 24 hours lasting blood glucose level above 11.1 mM/l (200 mg/dl) in spite of usual insulin therapy, 19 from them undergoing only Dt investigation with traditional treatment continuation. Ethic Committee agreements were obtained. Range of glycaemia normalization delays after the observation beginning, per cent of failure (glycaemia remaining above the hyperglycaemia threshold), hypoglycaemia and “yo-yo” episodes were analysed. Acceptable stability and reproducibility of the Dt measures were shown in thermostat, in animals and in healthy human volunteers. Compared with the traditional treatment, new feedback monitored insulin treatment has demonstrated: some acceleration of the glycaemia decrease during the first 3-4 hours, less treatment failures, yo-yo events, and deep hypoglycaemia episodes. In most cases, a 3-4 hour session significantly improved the patient condition. These first results suggest the validity of the new feedback for insulin therapy control.