A clinical trial, pioneered in Spain, studies the efficiency of an artificial pancreas
The Instituto ai2 of 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) are developing a clinical trial being pioneered in Spain, in order to study the efficiency of an artificial pancreas, one of the latest advances in diabetes technology.
The artificial pancreas is a device that automates insulin delivery from real-time measurements of glucose by means of a mathematical control algorithm. The artificial pancreas aims at achieving glycaemic objectives for any patient at any time by interconnecting current insulin pumps and continuous glucose monitors, already in use by type 1 diabetes patients.
Research on diabetes technology 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.
Currently, according to Jorge Bondia, “the patient undergoes an intensive insulin therapy, either with multiple daily injections or with continuous infusion with insulin pumps. The intensive insulin therapy can be very effective, but it causes an increase in hypoglycaemic episodes if insulin doses are overestimated. Severe hypoglycemia can lead to diabetic comma and even death”. Glycaemia monitoring is a basic element in the treatment and control of diabetic patients.
According to Dr. Ampudia-Blasco, from the Endocrinology Department of the Hospital Clínico Universitario, “Type 1 diabetes mellitus is a chronic disease which requires the administration of insulin for life. Today, for those patients who do not achieve an optimum glycaemc control with the administration of multiple insulin injections, the use of insulin pumps or systems of continuous subcutaneous infusion of insulin (CSII) can be an alternative. The research done for the last few years has proven that, besides these CSII systems, the joint use of an insulin pump and a continuous glucose monitoring system (CGM) can be useful for selected patients in order to improve the control of the glycaemia levels”.
However, the existing systems do not automatically make decisions, and they always require that the patient interprets the glucose number and decides what to do at any given time with respect to the dose of insulin they have to administer.
Recently, with the aim of improving the control of this disease, the T1DM patient conditions and their quality of life, different initiatives to automate the glucose monitoring and the insulin dosage have started. The closed-loop system, commonly known as artificial pancreas (AP), is a system that incorporates a smart control algorithm (controller), that interprets the results about the glucose provided every few minutes by a glucose sensor and decides the quantity of insulin which must be automatically administered at any time. Along this time, research on mathematical modelling of diabetes pathophysiology, glucose prediction under variability, insulin pump therapy optimization, calibration algorithms for continuous glucose monitors and algorithms for the artificial pancreas has been conducted.
In this context, one of the main problems these PA systems have to face is the control of the glucose numbers after meals, as they must avoid an excessive infusion of insulin, which can cause hypoglycaemia. Besides this, the PA must regulate the infusion of insulin during the night, where different prototypes have already proven its efficiency.
This trial intends to test the efficiency of an automatic controller with an original design for the adjustment of glucose levels after meals focusing on the analysis of how much variability the closed-loop system is able to compensate as compared to traditional insulin pump therapy. 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. “By controlling the glucose levels in the blood in a such effective way, we could reduce the health problems related to persistent hypoglycaemia,” says the Dr. Ampudia-Blasco.
20 patients with type 1 diabetes are taking part in the study with an CSII treatment: ten from the Hospital Clínico Universitario de Valencia and ten from the Hospital Clinic de Barcelona.
According to the Dr. Juan F. Ascaso, Head of the Endocrinology and Nutrition Department of the Hospital Clínico Universitario de Valencia, “the artificial pancreas should give the patients autonomy and safety, allowing them to live with the disease without obsession. Besides that, it must avoid the complications caused when glucose levels fall. It consists of an approach to custom-designed treatments for each patient which reduce the problems caused by the treatments and costs“.
According to the General Manager of the INCLIVA, Dr. Rafael Carmena, “this research brings a message of hope to the diabetic patients. The development of an artificial pancreas systems can improve, in the near future, the control of type 1 diabetes, the patients’ conditions and their quality of life. When they have been perfected, they will remove the necessity of manually injecting insulin and they will guarantee the administration of exact doses every time”.
Diabetes is increasing the burden of disease all over the world, particularly in developing countries. Causes are complex, but they are mostly related to a quick increase in weight, obesity and physical inactivity. The WHO expects diabetes to become the seventh leading cause of death worldwide in 2030 and calculates that the deaths from diabetes will increase by more than 50% in the next 10 years. Today, in the world, there are more than 347 million people with diabetes, among which approximately 10% suffer from type 1 diabetes..
This 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 Gandia 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. The study is part of the project CLOSEDLOOP4MEAL, funded by the Spanish Ministry of Economy and Competitiveness, and coordinated by Dr. Jorge Bondia.
Contact: Jorge Bondia
Further information about the project: http://www.insulaid2.org
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