Date: 2014-05-22
Type of information: Initiation of the trial
phase:
Announcement: initiation of the trial
Company: Universitat Politècnica de València, the Instituto de Investigación Sanitaria (INCLIVA) of the Hospital Clínico Universitario de Valencia (Spain), Hospital Clínic de Barcelona (Spain) Polytechnic School of the Universitat de Girona (Spain)
Product: artificial pancreas
Action mechanism:
Disease: diabetes
Therapeutic area: Metabolic diseases
Country: Spain
Trial details:
Latest
news: * On May 22, 2014, the Universitat Politècnica de València, the Instituto de Investigación Sanitaria (INCLIVA) of the Hospital Clínico Universitario de Valencia, the Hospital Clínic de Barcelona and the Polytechnic School of the Universitat de Girona (UdG) have started a clinical trial being pioneered in Spain, in order to study the efficiency of an artificial pancreas. The artificial pancreas is a device based on a control mathematical algorithm that calculates the optimal dose of insulin according to the needs of any patient at any time. It consists of providing the insulin pumps used by type 1 diabetes mellitus patients with an additional system (control algorithm) able to indicate the exact quantity of insulin needed by a patient at any time. The trial is lead by Dr. F. Javier Ampudia-Blasco, from the Endocrinology Department of the Hospital Clínico Universitario (Department Head: Dr. Juan Ascaso), in collaboration with the Dr. Paolo Rossetti, at the Hospital Fransesc de Borja in Gandía and researcher at the INCLIVA. Two engineers are also taking part as the main co-researchers, Jorge Bondia, from the Instituto Universitario de Automática e Informática Industrial of the UPV, and Josep Vehí, from the UdG, as well as Dr. Ignacio Conget, Dr. Marga Giménez and Dr. Carmen Quirós, from the Hospital Clínic de Barcelona. This trial is conducting a research project that dates back to 2004, when researchers at the Instituto Universitario de Automática e Informática Industrial of the UPV (Jorge Bondia) and at the Institute of Informatics and Applications of the Universitat de Girona (Josep Vehí) decided to search for solutions to one of the biggest problems for diabetes patients; determining the quantity of insulin necessary at any given time. This trial intends to test the efficiency of an automatic controller with an original design for the adjustment of glucose levels after meals. The controller interprets the glucose results provided by a glucose sensor and decides, every 15 minutes, the quantity of insulin that must be administered automatically. 20 patients with type 1 diabetes are to take part in the study with an ISCI treatment: ten from the Hospital Clínico Universitario de Valencia and ten from the Hospital Clinic de Barcelona. The first study was done last week with one patient at the Clínico de Valencia.
