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FP7

SPIDIMAN Report Summary

Project ID: 305343
Funded under: FP7-HEALTH
Country: Austria

Periodic Report Summary 3 - SPIDIMAN (Single-Port Insulin Infusion for Improved Diabetes Management)

Project Context and Objectives:
Existing therapeutic devices for diabetic patients suffer from bulky size, inaccurate measurements and difficult handling of two body interfaces. Suboptimal control of blood glucose levels in patients with type 1 or type 2 diabetes mellitus results in periods of hypo- and hyperglycemia leading to severe and life-threatening complications. Exploiting a novel glucose sensor technology, SPIDIMAN aims to improve glycemic 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 test an innovative artificial pancreas approach, and experienced partners 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 glycemic 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 specific focus of the project.

Project Results:
The 3rd period of the SPIDIMAN project was dedicated to clinical evaluation SPIDIMAN single-port system.

Sensor:
As the SPIDIMAN 01 clinical trial demonstrated that the transcutaneous read out of the SPIDIMAN sensor applied on infusion sets with 90° insertion does not deliver sufficient signal intensities and thus signal/noise ratios the SPIDIMAN concept was changed to use infusion sets for slanted insertion instead of 90 insertion. Clinical evaluation of the new concept was performed in December 2015. In this trial an adverse event happened due to insufficient adhesion of the diffusion barrier layer on the sensor. The diffusion barrier layer of 3 sensors remained in the tissue of the subjects. The study was interrupted and adhesion had to be improved to continue the clinical investigations.
Following counter measures were performed:
• The concentration of the adhesion promotors in the individual sensor layers was optimized.
• The enzyme catalase was incorporated into enzyme layer instead of the diffusion barrier layer of the sensor
• The concentration of water in the processing solution of the diffusion barrier layer was reduced significantly

The countermeasures delivered following results:
• In vitro tests demonstrated that 100% of 68 sensors passed adhesion tests with artificial skin
• Dynamic range of the sensor was increased with linear response in the range of 0 – 300mg/dl glucose.
• The sensor fabrication process was improved to produce the diffusion barrier with lower thickness and smoother surface which reduces shear forces during insertion and extraction of the sensor.

Glucose Reader:
The second generation of the glucose readers were used during the clinical trial. In the SPIDIMAN 02 clinical trial two adverse events were observed: The optical filters of the glucose readers were oxidized due to intrusion of sweat and/or disinfectant which impaired the functionality of the glucose readers. And there was also sweat intrusion into the glucose reader housing which caused malfunction of the glucose readers´ electronics.

Following counter measures were performed:
• Optical filters of the glucose readers were exchanged. The new filters are based on polymers instead on metal oxides.
• An additional acrylic protection sealing was applied on the optical windows of the glucose readers.
• The glucose readers will be placed in an additional patch with sealings to prevent sweat intrusion.

Clinical evaluation:
The SPIDIMAN 02 study was performed at the Clinical Research Center of Medical University of Graz from December 11th, 2015 to November 7th, 2016. The study was put on hold from December 23rd, 2015 until August 30th, 2016 due to adhesion problems of the sensor to the insulin infusion catheter.
The midterm analysis of the first 6 subjects of the clinical trial was performed. The Median ARD values of the sensors was 24.5%.

Potential Impact:
The new SPIDIMAN device will integrate advanced glucose measurement and accurate insulin delivery in an artificial pancreas (AP) approach to improve diabetes management in adults and children suffering from insulin-dependent diabetes. To improve on continuous glucose monitoring, a standard insulin infusion cannula coated with a glucose sensor will be developed as a new single-port AP. The coated insulin catheter is inserted into the subcutaneous tissue and will simultaneously be used for both glucose concentration measurement and insulin delivery in an integrated therapeutic device that has great potential to improve diabetes management in adults and children. To provide benefits to diabetes patients SPIDIMAN will meet the following objectives:

Develop a comprehensive coating technology:
The new coating technology will graft an optical glucose sensing layer ("smart tattoo") onto an off-the-shelf insulin infusion catheter.

Optimise the optical glucose measurement and control algorithms:
The optical reader will be optimised to increase the accuracy of glucose concentration measurements in tissue and, based on current approaches, appropriate control algorithms will be developed that incorporate the characteristics of the glycaemic management strategy for paediatric and adult type 1 diabetes patients.

Build a new single-port AP device:
All technical components and the optimised algorithm will be combined in a new single-port AP device with innovative optical glucose sensing technology.

Validate the new single-port AP in a preclinical setting:
The performance and applicability of the single-port AP device will be evaluated and optimised in a preclinical study and the control algorithm will be additionally evaluated using a novel in-silico approach.

Validate the new single-port AP in a clinical setting:
The performance and applicability of the single-port AP device and the complete single-port AP will be tested in clinical studies in adult and paediatric type 1 diabetes mellitus patients.

Impact
Due to the integration of a new sensor technology on existing cost- effective insulin infusion sets the expected costs for the new sensor-coated catheters will be low, thus helping to reduce the health care costs of diabetes management but also the cost stemming from inadequate glycaemic control. Inaccurate glycaemic management leads to hospitalisation cost for patients with both micro- and macrovascular complications that are 5.5 times higher than the costs for patients with no complications. In cooperation with the biomedical industry, SPIDIMAN prototypes can be used to improve glycaemic management, diabetes care, long-term prognosis, quality of life, life expectancy and general wellbeing for patients with diabetes through the availability of a highly acceptable, safe and effective AP device. This would have a significant impact on European healthcare expenditure by reducing costly long term complications associated with diabetes, making sustainable health care systems in Europe more sustainable.
Children with T1DM are particularly affected by insufficient diabetes management because of their highly variable lifestyles and their extreme insulin/glucose sensitivity, leading to hypo- and hyperglycaemic episodes. At a very young age many children are not able to communicate hypoglycaemic symptoms. The SPIDIMAN single-port AP system requires only one needle and provides a smaller monitoring device for better glycaemic management, increased quality of care and therefore quality of life and increased life expectancy. The use of a fully functional single-port AP will lead to tight glycaemic management particularly at night, and will provide a substantial improvement for paediatric T1DM patients and their families. It will offer an excellent treatment option for very young children due to the reduced number of insertion sites.

List of Websites:
www.spidiman.eu

Reported by

JOANNEUM RESEARCH FORSCHUNGSGESELLSCHAFT MBH
Austria
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