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Grant
Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2012.2.4.3-1 | Award Amount: 6.38M | Year: 2012

Existing therapeutic devices for diabetic patients suffer from bulky size, inaccurate measurements and the difficulties of handling two body interfaces. Suboptimal control of blood glucose levels in type 1 or type 2 diabetes mellitus patients results in periods of hypo- and hyperglycaemia leading to severe and life-threatening complications. Exploiting a novel glucose sensor technology, SPIDIMAN aims to improve glycaemic management for better quality of life and healthier aging. The consortium will develop a new coating technology to apply a glucose-sensitive fluorescent dye onto a standard insulin catheter and incorporate this integrated glucose sensor into a single-port artificial pancreas system. Advanced optical continuous glucose monitoring technology (smart tattoos) with improved sensor accuracy, faster response times, wider dynamic range and higher signal stability will advance diabetes management by reducing hypo- and hyperglycaemic episodes. Within SPIDIMAN, research-intensive European SMEs will develop an innovative artificial pancreas approach, and experienced participants will perform clinical validation in a European network of specialised diabetes centres. SPIDIMAN will thus pave the way for a single-port device that integrates improved glucose measurement and more accurate insulin delivery to provide better glycaemic management in patients with insulin-dependent diabetes. The new device is expected to be particularly suitable for patients in childhood and adolescence, who will form a special focus of the project.


Grant
Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2012.2.4.3-1 | Award Amount: 5.49M | Year: 2012

The aim of PCDIAB is to build and evaluate a bihormonal (insulin and glucagon) artificial pancreas (AP) with automated closed loop glycaemic control for insulin treated patients with diabetes. This will be a breakthrough in diabetes management. We will miniaturize our current prototype consisting of well-established continuous glucose monitors, an insulin pump and a glucagonpump. The housing will be redesigned with dedicated miniature motors and the software will be embedded. The algorithm will be improved and a continuous glucose sensor (CGM) per-formance alert will be developed. In parallel, glucagon pharmacology will be investigated and a stable liquid glu-cagon analogue will be developed. Furthermore, administration of insulin and glucagon together with continuous glucose monitoring at the same subcutaneous site will be investigated, to enable even further miniaturization in the future. Deliverables include description of system integration of the bihormonal AP system and of an online detection of continuous glucose monitor performance. In a multinational controlled trial the bihormonal AP will be compared with standard intensive insulin therapy in daily life. Impact of the project includes simplified diabetes care, improved quality of life for patients with diabetes, dimin-ished occurrence of diabetes related complications and diminished health costs in the long run. Also, the project will strengthen competitiveness of European industry across a complete value chain involving large, mid-sized and small companies, enabling Europe to lead progress in AP systems. Finally, the project will put European research and clinical organizations in leading positions with an increased number of high-skilled jobs in the medical device industry. Dissemination and exploitation comprises a website, a conference, patents and scientific publications. The bihormonal closed loop system and the glucagon analogue can be developed into a product and brought to the market.


Grant
Agency: Cordis | Branch: FP7 | Program: BSG-SME | Phase: SME-1 | Award Amount: 713.80K | Year: 2008

Blood glucose monitoring is important in the care of diabetes mellitus and is presently accomplished via a finger-stick in which a lancet is used to prick the finger and withdraw a small amount of blood for testing. The problem with the existing finger-stick-devices is that blood sampling is painful, it increases the risk for infections and the test is discontinuous. A method for measuring the status of a diabetes patient continuously is preferred, especially at night when the risk of undetected hypoglycaemia is present. Systems for continuous (non-invasive) blood glucose monitoring show promising results for measuring high blood glucose values (hyperglycaemia). However, these systems are not reliable when it comes to measuring low blood glucose values (hypoglycaemia). This is due to the fact that a small variation in the blood glucose concentration in the hypo-region has a great impact on the status of the patient. In this project volatile components emanated from the skin are used to determine the state of diabetes patient; one of these components is acetone. An apparatus to clinically test the relation between the amount of acetone and the state of hypoglycaemia (and the concentration of blood glucose) has to be developed. Clinical tests (clamp tests) will be performed in an (academic)hospital. Furthermore, research has to be performed into the combination of several techniques (e.g. impedance spectroscopy) with skin gas measurements to obtain an overall picture of the status of a diabetes patient. Measurements of acetone permeation through the skin and the use of membranes to protect the sensor and/or to enhance the signal are needed. Sensors need to be developed to miniaturise the system. The ultimate goal is to develop a sensing system capable of measuring the condition of a diabetes patient satisfactory and in addition is able to steer the function of, among others an insulin pump.


Grant
Agency: Cordis | Branch: FP7 | Program: BSG-SME | Phase: SME-1 | Award Amount: 1.19M | Year: 2010

Europe faces a diabetes epidemic. More than 55 million people in Europe are currently diagnosed with diabetes and with an estimated 20% increase by 2030, the disease is certain to stay one of the most challenging health problems this century. Especially as diabetes no longer is a disease exclusively for adults, but affects children, young people and adults of all ages. Despite the high prevalence of diabetes, the choice of anti-diabetic drugs is still limited and two thirds of patients with diabetes do not achieve the recommended glycaemic target levels. For each new anti-diabetic drug, it is essential to investigate the metabolic effect over time. The glucose clamp technique is regarded as the gold standard to evaluate the effectiveness of new anti-diabetic drugs. There are however only a few centers with limited research capacities that have experience in using the clamp technique, because automated clamp devices are no longer commercially available and the existing techniques are confounded by a number of limitations. Increased clamp capacities are urgently needed for the development of new, more efficacious anti-diabetic drugs. Through the integration of newly emerging technologies proposed in part by the 4 participating SME organisations and with the outsourced research capacity of 3 of Europes leading RTD performers, the EU-CLAMP project aims to develop a new generation automated clamp device that will overcome the limitations of the existing devices by incorporating microdialysis technique for reliable continuous glucose monitoring without blood loss. The EU-CLAMP project will facilitate clamp testing in a more efficient and cost effective manner. In addition to the significant contribution that will be made to development of improved treatment options for diabetes, the project will provide a platform from which the competitiveness of the participating SMEs can be improved offering alignment to the needs of their long term business strategies.


Grant
Agency: Cordis | Branch: FP7 | Program: CP | Phase: ICT-2009.5.1 | Award Amount: 13.64M | Year: 2010

The objective of AP@home is to build and evaluate an artificial pancreas (AP) with automated closed loop glycaemic control for insulin treated patients with diabetes. AP systems require algorithms using blood glucose levels obtained via glucose monitoring for controlling subcutaneous insulin administration. First, well established subcutaneous continuous glucose sensors and insulin pumps will be combined to improve and verify the functionality of enhanced closed-loop algorithms. We will advance algorithm quality, improve sensors by bringing their accuracy below the desired 5% error level and add a remote hypoglycaemia alarm. Second, in parallel, two AP systems will be developed by combining an insulin pump and a sensor into a single device, using only one access point through the skin (single-port). Thereby the need to puncture the skin twice, once for the glucose sensor and once for the insulin infusion, can be avoided (two-port). If proven successful in computer simulations we will evaluate the best selected single-port system under clinical conditions.\nDeliverables include: description of more precise glucose sensing methods; description of system integration of the two-port and both single-port AP systems; validation of prototypes in the clinic and at home. In a multinational controlled trial AP performance will be compared with standard intensive insulin therapy in daily life.\nImpact of the project includes strengthened competitiveness of European industry across a complete value chain involving large, mid-sized and small companies, enabling Europe to lead progress in AP systems. Also, the project will put European research and clinical organizations in leading positions with an increased number of high-skilled jobs in the medical device industry. Finally, diabetes care will be simplified, quality of life of patients with diabetes will be improved and diabetes related complications and health costs will diminish in the long run.

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