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MICELAB takes part in clinical trial for testing artificial pancreas

20/05/2014

The MICELAB research group of the IIiA takes part in a clinical trial for testing an artificial pancreas. 20 patients suffering from Type-1 diabetes (DT1), 10 at Hospital Clínic de València and 10 at Hospital Clínic de Barcelona, will test its efficiency in the first clinical trial of this type in Spain.

Under the direction of Dr Josep Vehí, MICELAB has developed a new algorithm to calculate the optimal dose of insulin needed by patients. The algorithm has been designed to suit the individual needs of each patient. These needs change over time and they are especially relevant after the meals. MICELAB along with researchers from the Universitat Politècnica de València (UPV), have succeeded at endowing insulin pumps with the control algorithm they have developed. In this way the pump delivers the exact amount of insulin needed.

Josep Vehí, remarks this practical test "is a very relevant milestone". "We have developed a medical device that has been approved by the Spanish Agency for Medicines and Healthcare Products. We have completed a cycle: research, development and prototype validation. Our product may have a real application in the mid term: it could hit the market in four or five year's time."

The clinical trial is the result of a joint effort by the Universitat de Girona (UdG), UPV, the Institut d'Investigació Sanitària (INCLIVA) at Hospital Clínic Universitari de València and the Hospital Clínic de Barcelona. Its origins are found in 2004, when  researchers at UdG and UPV started a research project to tackle one of the biggest challenges diabetes sufferers face: how to decide the right amount of insulin needed at every time. According to Jorge Bondia, engineer at UPV "The patient undergoes massive therapy, either multiple daily injections or continuous infusion  by means of pumps. The latter is very efficient but it can lead to hypoglycaemic episodes. Moreover, very low levels of insulin can result in a diabetic coma."  Therefore, monitoring the level of glucose is essential for the proper treatment and control of patients suffering from diabetes.

As diabetes is a chronic illness, insulin must be continuously delivered throughout the patient's life. Current systems to deliver insulin are not intelligent. This means that diabetes sufferers must construe the level of glucose and decide every time the right dose of insulin to be delivered.

Josep Vehí asserts that controlling glycaemia at meal times "is not trivial".  Diabetes sufferers must use difficult formulas to find out the amount of insulin they need. "They must take into account multiple variables and they may feel uncomfortable about it". This is why the artificial pancreas main goal is to automate the monitoring of glucose and the delivery of the right dose of insulin. By achieving this goal,  the patient's illness is better controlled and her quality of life is also improved as she enjoys more autonomy and security.

Controlling the amounts of glucose after meals is one of the biggest challenges an artificial pancreas faces. Too much insulin might result in hypoglycaemias. The clinical trial will focus on this point. It will analyse the amounts of glucose for eight hours starting just after the meals. It will test how efficient the automatic controller is  at controlling the level of glucose. The controller reads the levels of glucose measured by a sensor and makes a decision on the insulin dose every 15 minutes.