A dream for diabetes patients is about to come true: A wearable artificial pancreas that automatically regulates your insulin delivery, while living your normal live. The EU-funded AP@home project has developed a prototype to reduce the treatment burden for people with insulin treated diabetes.
Professor Dr. Lutz Heinemann, coordinator of the project. says: “The AP we developed allows automated glucose control; it continuously monitors glucose (sugar) levels in the body and it includes a software algorithm that calculates how much insulin should be delivered at any given time via an insulin infusion pump. (…) Automating the delivery of insulin would greatly improve treatment sinc.
The next step is to develop this prototype system into a product.
In order to improve treatment of diabetes patients using insulin, AP@home aimed to build and evaluate an artificial pancreas (AP) that works reliably day and night under at home conditions.
Up to date, insulin is given either by injections or via wearable continuous infusion pumps.
Communication between monitor and pump
The AP@home project developed an AP platform that establishes the communication between the commercially available continuous glucose monitor and the insulin pump and runs the software algorithms that are a proprietary development of partners of the project.
At present two different versions of the AP platform are still being evaluated in the home environment of patients; they are using it for up to three months at home without constant supervision by a physician, living their normal lives.
In parallel, AP@home developed an innovative AP device that combines an insulin pump and a glucose sensor in one device. It uses only one access point through the skin. This novel AP system is currently investigated at the patients’ home as well, currently only for a short period of time.
The development from prototype into a product will take place in the coming years. The product should simplify diabetes care, improve the quality of life of patients with diabetes and reduce the risk of diabetes related complications and diminish health costs in the long run.
The AP@home project was funded through the 7th Framework Program. It started in 2010 and has just come to an end. Universities and companies in Germany, the UK, the Netherlands, France, Austria, Switzerland and Italy participated in the project.
The artificial pancreas is a technology in development to help people with diabetes automatically control their blood glucose level by providing the substitute endocrine functionality of a healthy pancreas.
There are several important exocrine (digestive) and endocrine (hormonal) functions of the pancreas, but it is the lack of insulin production which is the motivation to develop a substitute. While the current state of insulin replacement therapy is appreciated for its life-saving capability, the task of manually managing the blood sugar level with insulin alone is arduous and inadequate.
The goal of the artificial pancreas is twofold:
1. to improve insulin replacement therapy until glycemic control is practically normal as evident by the avoidance of the complications of hyperglycemia, and
2. to ease the burden of therapy for the insulin-dependent.
The overall strategy of AP@home is
- to create a new improved two-port AP based on well established components for optimization, verification and validation of current preliminary algorithms in clinical studies
- to develop and validate a single-port AP. The division of the work in objectives and work packages follows this AP@home strategy.
WP 11 Improving glucose sensing and insulin infusion (RTD)
WP 12 Modelling, simulation and control (RTD)
WP 13 System integration of insulin pump, continuous glucose monitor and connection to health care systems (RTD)
WP 21 Development of new single-port artificial pancreas systems (RTD)
WP 31 Clinical validation of the AP systems (RTD)
WP 32 Home validation of the AP system and remote control (RTD)
WP 41 Coordination (MGT)
WP 42 Dissemination and Use (OTH)
Our expected outcomes are:
- A two-port AP system with automated closed –loop glycaemic control to monitor and treatment diabetes patients remotely at the point of need, independent of their location, meal intake and activities. This two-port AP system will be connected to the health care provider by a wireless telemedicine platform comprising the latest ICT connection technologies as smart phones, blue tooth etc, facilitating an improved link and interaction between patients and doctors and a more active participation of patients in their care process.
- A risk assessment model built on heterogeneous clinical data and tested in an in silico environment and in patients in a hospital environment and at home, addressing also the needs of elderly people, a growing group of insulin treated people with diabetes;
- A top-notch algorithm for continuous glucose monitoring for more precise assessment of the health status with an error level of less than 5%;
- A hypo-/hyper-glycaemia alarm for safer and more accurate treatment. This alarm would improve the willingness of the patients to adopt tight glycaemic control leading to less clinical complications and hospitalisation;
- The first prototype of a single-port AP system based on a nanoscale infusion pump architecture using biocompatible material, microneedles and miniturized drug delivery technologies based on microfluid features incorporating the e-Health application solutions of AP@home as the automated closed-loop glycaemic control, the wireless telemedicine platform, the risk assessment model, the top-notch algorithm for measuring the glucose and the hypo-/hyper-glycaemia alarm.
All these expected outcomes will lead to a real break through in the field of diabetes health systems. The outcomes will a) improve disease management through more precise measurement of health status and involvement of the patients in their care process, increase the world wide access of patients to better, secure and safe personalized health systems and reduce hospitalization and its costs without compromising the health care quality and b) reinforce the leadership and innovation of the industrial partners and contribute to the knowledge-based society and accelerate the establishment of standards on personal health systems for diabetes.
How AP@home serves the public good
One of the major objectives of the AP@home project is to disseminate the outcome of this EU-funded project. Our dissemination process is a planned process of providing information on the quality, relevance and effectiveness of the results of our project. This involves:
- preparing the ground for our work,
- carrying out our project while harvesting its results,
- distributing these results to the various interested groups and stakeholders, and
- ensure that others can benefit from the project’s output.
Dissemination of knowledge
We are quite confident that the results of the AP@home project can have a major impact on diabetes, eHealth and medical research in Europe. One of the reasons for this believe is the active involvement of many different groups across Europe. The achievements, knowledge, practical experience and guidance that are emerging from carrying out the work in our project will be disseminated actively to different target audiences such as the scientific, clinical and health care community and in particular patient organisations.
Satisfying the high need for a “technical cure”
In view of the rapid increase in the number of patients with diabetes in Europe, we see a high need for a “technical cure” of this disease as this can keep many people who would otherwise become disabled in a position that allows them to continue to work actively.
Sensitising the usage of Diabetes Technology in Europe
We regard this project also as helpful to promote the usage of Diabetes Technology (which will cumulate into the development an artificial pancreas (AP) system) inside Europe. In view of the considerable number of internationally recognized academic experts working in the AP@home project and the excellent industrial partners working with us, we are very confident that we will be able to bring an AP system home to patients with diabetes within the timeframe of this project. Our initiative is very well in line with the massive increase in the interest in this topic.