CLOSE is the acronym for Automated Glucose Control at Home for People with Chronic Disease. It is one of the first EIT Health Innovation Projects and provides a paradigm example for implementing the EIT knowledge triangle integrating technology advancement, education and business creation.
CLOSE develops and deploys integrated solutions for persons with type 2 diabetes centered on Automated Insulin Delivery, also known as artificial pancreas (AP). CLOSE tailors the AP system to the needs of persons with type 2 diabetes and complements the device by offering obligatory trainings as well as outcome predictors and performance indicators (APplus).
By developing superior risk-benefit and cost-benefit scenarios for AP operation in type 2 diabetes, CLOSE aims to achieve positive acceptance by users and caregivers and a high eligibility for reimbursement. CLOSE is going to initially launch an APplus product and service package in the framework of French homecare service provision.
CLOSE is the first AP business initiative directly targeting persons with type 2 diabetes. Using a co-creation approach, CLOSE is going to develop superior risk-benefit and cost-benefit scenarios for AP operation in type 2 diabetes, thereby achieving positive acceptance by users and caregivers and a high eligibility for reimbursement.
CLOSE is unique in operating at the heart of a real-world homecare service provision ecosystem, paving the roads between prescribers, patients and payers. CLOSE currently conducts a multi-center clinical trial (NCT04233229) for the real-world assessment of glycemic effectiveness, patient-reported outcome measures (PROMs), as well as economic and process-related endpoints.
Following the initial launch of APplus in France CLOSE will scale up the APplus business by pursuing geographic distribution, targeting additional audiences and enhancing AP functionalities and interconnectedness.
The conception and design of the CLOSE project was recently explained in a peer-reviewed article and discussed by internationally renowned experts from NIH.
Figure 1: The artificial pancreas (AP) core system approaches a “technical cure” of diabetes by closing the loop between blood glucose levels and insulin infusion when the continuous subcutaneous insulin infusion (CSII) rates are varied by a control algorithm (CONT) taking changes in glucose levels into account. The algorithm can be implemented in a smart phone. The communication between the components can be established via Bluetooth. Real-time glucose levels are measured continuously in the interstitial fluid by a glucose sensor (CGM).
Figure 2: APplus product and service package for people with T2D on homecare (French APplus paradigm). APplus comprises the AP, obligatory training and education modules, and a panel of outcome predictors and performance indicators helping to identify patients who might benefit most from AP usage and to measure the impact of AP usage on the quality and effectiveness of diabetes care.
The consortium behind CLOSE is diverse and mutually reinforcing. Profil GmbH – a full-service CRO for early clinical trials in diabetes, obesity and cardiometabolic disease – coordinates the CLOSE initiative in collaboration with Air Liquide Healthcare and is supported by EURICE GmbH. Profil GmbH is a co-founder of the EIT Health Knowledge and Innovation Community – the network of top-of-the-range health innovators supported by the European Union.
CLOSE partners hold key capabilities in healthcare service provision, AP development and clinical evaluation, education & training, performance measurement, as well as at market implementation and advancement of diabetes technologies. In addition, expertise in healthcare research, economic modelling, and the development of performance measurement instruments is available within the partnership. The CLOSE partnership has been established and received funding under the umbrella of EIT Health. There are close collaborations with other European initiatives including D4Kids, D4Teens, AP@home, and RealWorld4Clinic.
CLOSE Partners:
Profil, Profil Mainz, Air Liquide Healthcare, Sanofi, Catholic University of Leuven, Medical University of Lodz, IESE Business School, aQua Institute, European Research and Project Office (EURICE).
CLOSE Advisory Board:
CLOSE receives valuable advice from the CLOSE Advisory Board members Prof. Dr Eric Renard (Centre Hospitalier Universitaire de Montpellier, Department of Endocrinology, Diabetes and Nutrition), Prof. Dr Yves Reznik (Centre Hospitalier Universitaire de Caen, Service d’Endocrinologie) and Prof. Dr Lutz Heinemann (Science Consulting in Diabetes GmbH).
