In bringing innovative, home-based closed-loop insulin treatment to patients with Type 2 Diabetes Mellitus, CLOSE tackles one of the most threatening and challenging pandemic diseases of our time; and as such it has been groundbreaking for many other EIT Health projects in this area. Core offer of the project is to control blood glucose levels by means of an Artificial Pancreas (AP), which is installed at patients’ homes and remotely monitored and operated by trained care givers using a telehealth approach. CLOSE brings this integrated technology and service package (APplus) to patients suffering from Type 2 Diabetes (T2D) and related co-morbidities, which are particularly sensitive to a deterioration in glycemic control. In order to prevent further losses in health and well-being or increases in dependency and hospitalization of this vulnerable group of patients, intense care administering standard insulin treatments many times per day is needed, which is known to be error-prone as well as being resource and cost intensive.
In this context CLOSE offers high levels of adaptability combined with the potential for personalisation and customization of APplus. Using homecare as a starting point APplus is easily adapted to both clinical settings as well as homecare settings of patients suffering from T2D without co-morbidities. Additionally, the team uses a ‘train-the-trainer’ approach to develop and maintain a network of professionals delivering training sessions to those installing, operating and monitoring APplus at home guarantees a safe and cost-effective operation of AP+. APplus greatly impacts the quality and cost effectiveness of diabetes care reducing complex interventions and initiating tailored health care services for T2D patients to improve their quality of life as well as those of their family members. Further, APplus strives to also improve the working conditions and job satisfaction for caregivers, substantially helping to stabilise regional health economies all over Europe.
The CLOSE consortium and project would not exist without EIT Health. The project extends the capabilities of an already existing, integrated homecare operations service platform by EIT Health Core Partner Air Liquide Santé International (short: Air Liquide). Air Liquide’s service is also the basis for developing the future French use case.
With CLOSE Air Liquide continues to occupy a leadership position within Europe in the provision of homecare services and in the facilitation of access to new therapies through innovative technologies and services. Successful integration of APplus within its existing French homecare operations service platform will be an excellent basis for entering other European markets and adapting the use case to home-based diabetes care in other European countries. Thereby, demonstration of the numerous benefits of APplus within a large-scale, existing homecare service environment provides payers and physicians alike with the evidence needed to bring the tangible advantages this technology has over currently existing treatment options to the patients most in need. By consistently using the EIT Health knowledge triangle CLOSE will achieve the triple goal of improving the care experience and satisfaction of patients, the health of chronic patients, and the sustainability of healthcare systems all over Europe.
Air Liquide, Sanofi and Profil GmbH attribute CLOSE as the key project that supported the establishment of a strategic collaboration between them and enabled them to apply a new innovation pathway to in-home diabetes care all across Europe. CLOSE paves the road to prescribers, patients and payers alike, thus enabling the first of its kind demonstration of an effective, safe and cost-efficient operation of APplus. The EU-wide commercialisation of APplus will see the APplus portfolio be tailored to different care and reimbursement environments thereby boosting the growth of SMEs across the sectors of health technology, telehealth, training, and health care services.
In 2019 the focus of CLOSE will be on the clinical validation of APplus in a real-life, French homecare service system. Overseen by its internationally staffed Scientific Advisory Board CLOSE will implement a controlled clinical trial, which will address patient experience, satisfaction and patient-reported outcomes, beyond the standard safety and efficacy measures for blood glucose control.
Recently, CLOSE attracted international recognition in renowned specialist publications:
As Andrew A. Bremer, of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and Guillermo Arreaza-Rubin, of the National Institute of Diabetes and Digestive and Kidney Diseases – both National Institutes of Health (NIH) institutions – write in their publication in the Journal of Diabetes Science and Technology, the outcome of the CLOSE project will inform the creation of future treatment guidelines. The authors recommend that the CLOSE approach be applied to other emerging diabetes technologies by testing them with a model like APplus, the multi-stakeholder solution advocated by the CLOSE project. Bremer and Arreaza-Rubin’s article was based on a review of a 21 September 2018 article in the same journal by Prof. Dr. Freimut Schliess, leader of the CLOSE project, and a consortium of 20 additional co-authors.