A clinical trial to test a new model of an "artificial pancreas" is being pioneered in Spain

May 23, 2014, Asociacion RUVID
A clinical trial to test a new model of an “artificial pancreas” is being pioneered in Spain
Clinical trial of “artificial pancreas.” Credit UPV

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 of healthcare technology 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 according to the needs of any patient at any time. It consists of providing the insulin pumps used by 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 emerges from 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.

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 is very effective, but it causes an increase in hypoglycaemic episodes. Another problem is that very low insulin levels can lead to a diabetic coma." Glycaemia monitoring is a basic element in the treatment and control of diabetic patients.

According to Dr. Ampudia-Blasco, "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 glycaemia control with the administration of multiple insulin injections, the use of insulin pumps or systems of continuous subcutaneous infusion of insulin (ISCI, in Spanish) can be an alternative. The research done for the last few years has proven that, besides these ISCI systems, the joint use of an and a continuous glucose monitoring system (MCG, in Spanish), 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 DT1 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 (PA, in Spanish), is a system that incorporates a smart control algorithm (controller), that interprets the results about the glucose provided by a glucose sensor and decides the quantity of insulin which must be automatically administered at any time.

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 equipment has already proven its efficiency.

This trial intends to test the efficiency of an automatic controller with an original design for the adjustment of 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. "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 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.

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 diabetic patients. The development of an system can improve, in the near future, the control of type 1 diabetes, the patients' conditions, and their quality of life. When the technology has been perfected, it will remove the necessity of manually injecting insulin and guarantee the administration of exact doses every time."

About Diabetes

Chronic hypoglycaemia, even in absence of symptoms, implies damage to multiple tissues, especially in the small retinal vessels, kidneys and peripheral nerves. That is why diabetes is one of the main causes of blindness, amputation and terminal kidney disease in developed societies.

In addition, diabetes implies an important risk of heart disease (ECV, in Spanish), as much for itself as for its relation to other risk factors, such as high blood pressure or dyslipidemia.

In the world, there are more than 347 million people with diabetes. In the Comunitat Valenciana, 14% of the population is affected.

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.

Two big types of diabetes exist. Type 1 diabetes, in which the body does not produce insulin, and type 2 , the most common, in which the body does not efficiently use the insulin.

Type 1 is a chronic disease that consists of selective destruction of the cells responsible for insulin production. After an asymptomatic period, when the pancreas cell destruction is complete and the clinical diagnosis is done, the disease requires insulin administration for life.

Explore further: New method improves ability to continuously measure glucose in diabetic patients

Related Stories

New method improves ability to continuously measure glucose in diabetic patients

May 8, 2013
Researchers at the Universitat Politècnica de València and the Universitat de Girona have developed a new method for continuous glucose monitoring in patients with type 1 diabetes. It is based on a new calibration algorithm ...

Intensive insulin provides survival

May 13, 2014
Long-term follow-up of the DIGAMI 1 trial – a landmark study of type 2 diabetes in Sweden – shows that intensive insulin treatment prolonged life by more than 2 years in patients with diabetes after a heart attack, compared ...

Model predicts blood glucose levels 30 minutes later

March 25, 2014
A mathematical model created by Penn State researchers can predict with more than 90 percent accuracy the blood glucose levels of individuals with type 1 diabetes up to 30 minutes in advance of imminent changes in their levels—plenty ...

Dual-hormone artificial pancreas is a step closer for patients with Type 1 diabetes

January 28, 2013
For patients with type 1 diabetes, a dual-hormone artificial pancreas system (also known as a closed-loop delivery system) improved the control of glucose levels and reduced the risk of hypoglycemia compared with conventional ...

Overnight home use of artificial pancreas 'feasible and beneficial'

April 23, 2014
(Medical Xpress)—Children with type 1 diabetes have been able to use pioneering artificial pancreas technology, developed at the University of Cambridge, for the first time overnight at home without the supervision of researchers.

Blood sugar testing with no sharps

March 13, 2014
Measuring blood sugar when you have diabetes usually involves pricking your finger and using a glucose monitor for the test. While this approach can give people with diabetes vital information about whether they need to take ...

Recommended for you

Genetic discovery may help better identify children at risk for type 1 diabetes

January 17, 2018
Six novel chromosomal regions identified by scientists leading a large, prospective study of children at risk for type 1 diabetes will enable the discovery of more genes that cause the disease and more targets for treating ...

Thirty-year study shows women who breastfeed for six months or more reduce their diabetes risk

January 16, 2018
In a long-term national study, breastfeeding for six months or longer cuts the risk of developing type 2 diabetes nearly in half for women throughout their childbearing years, according to new Kaiser Permanente research published ...

Women who have gestational diabetes in pregnancy are at higher risk of future health issues

January 16, 2018
Women who have gestational diabetes mellitus (GDM) during pregnancy have a higher than usual risk of developing type 2 diabetes, hypertension, and ischemic heart disease in the future, according to new research led by the ...

Diabetes gene found that causes low and high blood sugar levels in the same family

January 15, 2018
A study of families with rare blood sugar conditions has revealed a new gene thought to be critical in the regulation of insulin, the key hormone in diabetes.

Discovery could lead to new therapies for diabetics

January 12, 2018
New research by MDI Biological Laboratory scientist Sandra Rieger, Ph.D., and her team has demonstrated that an enzyme she had previously identified as playing a role in peripheral neuropathy induced by cancer chemotherapy ...

Enzyme shown to regulate inflammation and metabolism in fat tissue

January 11, 2018
The human body has two primary kinds of fat—white fat, which stores excess calories and is associated with obesity, and brown fat, which burns calories in order to produce heat and has garnered interest as a potential means ...


Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.