EIT Health Innovation Project
CLOSE

CLOSE – Automated glucose control at home for people with chronic disease

CLOSE is one of the first EIT Health Innovation Projects and developed and deployed integrated solutions (APplus) centered on closed-loop metabolic control by means of an artificial pancreas (AP) for people with diabetes.

APplus comprises a product and service package complementing the AP by obligatory training as well as home visits and telemedical consultations on demand. Outcome predictors and performance indicators shall help to identify people who could benefit most from AP use and facilitate the measurement of AP impact in diabetes care. CLOSE established a scalable AP+ model case working at the interface between patients, homcare service providers, and payers in France. CLOSE will then scale up APplus by pursuing geographic distribution, targeting additional audiences and by enhancing AP functionalities and interconnectedness.

 

By being part of the EIT Health public-private partnership, CLOSE is committed to the EIT “knowledge triangle” pursuing the integrated advancement of technology, education and business creation. Putting stakeholders, education, and impact into the center of APplus advancement is considered key for achieving a wide AP use in diabetes care.

CLOSE stands for an EIT Health innovation project designed to overcome barriers to a wide-scale marketing of artificial pancreas (AP) systems for diabetes care. A key objective of CLOSE is to develop superior risk-benefit and cost-benefit scenarios for AP operation thereby achieving a positive acceptance by users and caregivers and a high eligibility for reimbursement. To meet this objective CLOSE will put the AP into the center of comprehensive APplus product and service packages specifically tailored to the needs and requirements of defined type 2 diabetes (T2D) patient groups and care environments.

APplus product and service packages complement the AP system by obligatory training as well as home visits and telemedical consultations on demand. Outcome predictors and performance indicators shall help to identify people who could benefit most from AP usage and facilitate the measurement of AP impact on health, care operations, and costs. A multi-stakeholder approach engaging in a continuous dialogue with users, healthcare providers and other stakeholders in diabetes care is going to inform the design and validation of APplus solutions.

Initially CLOSE follows a co-creative approach by developing an APplus paradigm at the heart of French homecare service provision targeting severely ill people with T2D. French homecare service provider operate fully integrated chronic care platforms at the cross-roads between patients, health professionals, payers, and prescribers while using proven methods and processes being based on established policies. By establishing a French APplus paradigm case CLOSE will prove a safe and cost-effective AP usage in a real-world healthcare scenario.

Enabling a massive and multi-dimensional APplus scalability is another key objective of CLOSE. Using homecare as a starting point and learning lab APplus can be easily adapted to additional patient groups and care environments. The geographic scalability will benefit from a careful consideration of existing local/national competencies and healthcare structures. A train-the-trainer approach to efficiently develop and maintain a network of professionals delivering trainings to those installing, operating, and monitoring AP+ operation will guarantee a safe and cost effective operation of AP+ wherever. Converging with other strands of health innovations functionally enhanced and interconnected AP systems will contribute to a fully integrated personalised diabetes management. Following the triple aim approach to optimizing the sustainability of healthcare a wide AP implementation in diabetes care should improve the interactions of the individual patients’ care experience, the health of the respective patient population, and the per capita healthcare costs, thereby making the AP attractive also for usage within the scope of pay-for-performance models.

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 CLOSE EIT Health innovation project is executed by a partnership which has been established under the umbrella of EIT Health. CLOSE partners hold key capabilities in healthcare service provision, AP development, education & training, performance measurement as well as 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. 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) and Prof. Dr Lutz Heinemann (Profil GmbH).

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Prof. Dr. Freimut Schliess

Director Science & Innovation Profil Institut für Stoffwechselforschung GmbH

Publications To Date

2018

Zijlstra E. Analysis of “Laboratory and Benchtop Performance of a Mealtime Insulin Delivery System” J Diabetes Sci Technol. 2018 Apr 1:1932296818767940. doi: 10.1177/1932296818767940. [Epub ahead of print]

Zijlstra E, Coester HV, Heise T, Plum-Mörschel L, Rasmussen O, Rikte T, Pedersen LK, Qvist M, Sparre T. Injecting without pressing a button: An exploratory study of a shield-triggered injection mechanism. Diabetes Obes Metab. 2018 May;20(5):1140-1147. doi: 10.1111/dom.13203.

Zijlstra E, Jahnke J, Fischer A, Kapitza C, Forst T. Impact of injection speed, volume, and site on pain sensation. J Diabetes Sci Technol. 2018 Jan;12(1):163-168. doi: 10.1177/1932296817735121.

Zijlstra E, Demissie M, Graungaard T, Heise T, Nosek L, Bode B. Investigation of pump compatibility of fast-acting insulin aspart in subjects with type 1 diabetes. J Diabetes Sci Technol. 2018 Jan;12(1):145-151. doi: 10.1177/1932296817730375.

Ruan Y, Bally L, Thabit H, Leelarathna L, Hartnell S, Tauschmann M, Wilinska ME, Evans ML, Mader JK, Kojzar H, Dellweg S, Benesch C, Arnolds S, Pieber TR, Hovorka R. Hypoglycaemia incidence and recovery during home use of hybrid closed-loop insulin delivery in adults with type 1 diabetes Diabetes Obes Metab. 2018 Mar 25. doi: 10.1111/dom.13304. [Epub ahead of print]

Bally L, Thabit H, Ruan Y, Mader JK, Kojzar H, Dellweg S, Benesch C, Hartnell S, Leelarathna L, Wilinska ME, Evans ML, Arnolds S, Pieber TR, Hovorka R. Bolusing frequency and amount impacts glucose control during hybrid closed-loop. Diabet Med. 2018 Mar;35(3):347-351. doi: 10.1111/dme.

2017

Emami A, Willinska ME, Thabit H, Leelarathna L, Hartnell S, Dellweg S, Benesch C, Mader JK, Holzer M, Kojzar H, Pieber TR, Arnolds S, Evans ML, Hovorka R. Behavioral patterns and associations with glucose control during 12-week randomized free-living clinical trial of day and night hybrid closed-loop insulin delivery in adults with type 1 diabetes. Diabetes Technol Ther. 2017 Jul;19(7):433-437. doi: 10.1089/dia.2016.0307.

Ruan Y, Thabit H, Leelarathna L, Hartnell S, Wilinska ME, Tauschmann M, Dellweg S, Benesch C, Mader JK, Holzer M, Kojzar H, Evans ML, Pieber TR, Arnolds S, Hovorka R; AP@home consortium. Faster insulin action is associated with improved glycaemic outcomes during closed-loop insulin delivery and sensor-augmented pump therapy in adults with type 1 diabetes. Diabetes Obes Metab. 2017 Oct;19(10):1485-1489. doi: 10.1111/dom.12956.

Barnard KD, Wysocki T, Ully V, Mader JK, Pieber TR, Thabit H, Tauschmann M, Leelarathna L, Hartnell S, Acerini CL, Wilinska ME, Dellweg S, Benesch C, Arnolds S, Holzer M, Kojzar H, Campbell F, Yong J, Pichierri J, Hindmarsh P, Heinemann L, Evans ML, Hovorka R. Closing the loop in adults, children and adolescents with suboptimally controlled type 1 diabetes under free living conditions: a Psychosocial substudy. J Diabetes Sci Technol. 2017 Nov;11(6):1080-1088. doi: 10.1177/1932296817702656.

Kuhlenkötter M, Heise T, Benesch C. Improved algorithm for automated glucose clamps. Diabetes Technol Ther. 2017 Feb;19(2):124-130. doi: 10.1089/dia.2016.0355.

2016

Zijlstra E, Heinemann L, Fischer A, Kapitza C. A comprehensive performance evaluation of five blood glucose systems in the hypo-, eu-, and hyperglycemic range. J Diabetes Sci Technol. 2016 Nov 1;10(6):1316-1323.

Heise T, Zijlstra E, Nosek L, Rikte T, Haahr H. Pharmacological properties of faster-acting insulin aspart vs insulin aspart in patients with type 1 diabetes receiving continuous subcutaneous insulin infusion: a randomized, double-blind, crossover trial. Diabetes Obes Metab. 2017 Feb;19(2):208-215. doi: 10.1111/dom.12803.

Leelarathna L, Thabit H, Hartnell S, Willinska ME, Dellweg S, Benesch C, Mader JK, Holzer M, Kojzar H, Evans ML, Arnolds S, Pieber TR, Hovorka R; AP@home Consortium. Rapid benefits of structured optimization and sensor-augmented insulin pump therapy in adults with type 1 diabetes. Diabetes Sci Technol. 2017 Jan;11(1):180-181. doi: 10.1177/1932296816654715.

Heise T, Zijlstra E, Nosek L, Heckermann S, Plum-Mörschel L, Forst T. Euglycaemic glucose clamp: what it can and cannot do, and how to do it. Diabetes Obes Metab. 2016 Oct;18(10):962-72. doi: 10.1111/dom.12703.

Maahs DM, Buckingham BA, Castle JR, Cinar A, Damiano ER, Dassau E, DeVries JH, Doyle FJ 3rd, Griffen SC, Haidar A, Heinemann L, Hovorka R, Jones TW, Kollman C, Kovatchev B, Levy BL, Nimri R, O’Neal DN, Philip M, Renard E, Russell SJ, Weinzimer SA, Zisser H, Lum JW. Outcome measures for artificial pancreas clinical trials: a consensus report. Diabetes Care. 2016 Jul;39(7):1175-9. doi: 10.2337/dc15-2716.

Heinemann L, Benesch C, DeVries JH; AP@home Consortium. AP@home: the artificial pancreas is now at home.Diabetes Sci Technol. 2016 Jun 28;10(4):950-8. doi: 10.1177/1932296816632002.

Ruan Y, Thabit H, Leelarathna L, Hartnell S, Willinska ME, Dellweg S, Benesch C, Mader JK, Holzer M, Kojzar H, Evans ML, Pieber TR, Arnolds S, Hovorka R; AP@home Consortium. Variability of insulin requirements over 12 weeks of closed-loop insulin delivery in adults with type 1 diabetes. Diabetes Care. 2016 May;39(5):830-2. doi: 10.2337/dc15-2623.

2015

Thabit H, Tauschmann M, Allen JM, Leelarathna L, Hartnell S, Wilinska ME, Acerini CL, Dellweg S, Benesch C, Heinemann L, Mader JK, Holzer M, Kojzar H, Exall J, Yong J, Pichierri J, Barnard KD, Kollman C, Cheng P, Hindmarsh PC, Campbell FM, Arnolds S, Pieber TR, Evans ML, Dunger DB, Hovorka R. Home use of an artificial beta cell in type 1 diabetes. N Engl J Med. 2015 Nov 26;373(22):2129-2140. doi: 10.1056/NEJMoa1509351.

Benesch C, Heise T, Klein O, Heinemann L, Arnolds S. How to assess the quality of glucose clamps? Evaluation of clamps performed with ClampArt, a novel automated clamp device. J Diabetes Sci Technol. 2015 Jul;9(4):792-800. doi: 10.1177/1932296815576957.

Arnolds S, Heckermann S, Heise T, Sawicki PT. Spectrum of diabetes research does not reflect patients’ scientific preferences: a longitudinal evaluation of diabetes research areas 2010-2013 vs. a cross-sectional survey in patients with diabetes. Exp Clin Endocrinol Diabetes. 2015 May;123(5):299-302. doi: 10.1055/s-0034-1398591.

2014

Leelarathna L, Dellweg S, Mader JK, Barnard K, Benesch C, Ellmerer M, Heinemann L, Kojzar H, Thabit H, Wilinska ME, Wysocki T, Pieber TR, Arnolds S, Evans ML, Hovorka R; AP@home consortium. Assessing the effectiveness of 3 months day and night home closed-loop insulin delivery in adults with suboptimally controlled type 1 diabetes: a randomised crossover study protocol. BMJ Open. 2014 Sep 3;4(9):e006075. doi: 10.1136/bmjopen-2014-006075.

Leelarathna L, Dellweg S, Mader JK, Allen JM, Benesch C, Doll W, Ellmerer M, Hartnell S, Heinemann L, Kojzar H, Michalewski L, Nodale M, Thabit H, Wilinska ME, Pieber TR, Arnolds S, Evans ML, Hovorka R; AP@home Consortium. Day and night home closed-loop insulin delivery in adults with type 1 diabetes: three-center randomized crossover study. Diabetes Care. 2014 Jul;37(7):1931-7. doi: 10.2337/dc13-2911.

2013

Luijf YM, DeVries JH, Zwinderman K, Leelarathna L, Nodale M, Caldwell K, Kumareswaran K, Elleri D, Allen JM, Wilinska ME, Evans ML, Hovorka R, Doll W, Ellmerer M, Mader JK, Renard E, Place J, Farret A, Cobelli C, Del Favero S, Dalla Man C, Avogaro A, Bruttomesso D, Filippi A, Scotton R, Magni L, Lanzola G, Di Palma F, Soru P, Toffanin C, De Nicolao G, Arnolds S, Benesch C, Heinemann L; AP@home Consortium. Day and night closed-loop control in adults with type 1 diabetes: a comparison of two closed-loop algorithms driving continuous subcutaneous insulin infusion versus patient self-management. Diabetes Care. 2013 Dec;36(12):3882-7. doi: 10.2337/dc12-1956.

Luijf YM, Arnolds S, Avogaro A, Benesch C, Bruttomesso D, Farret A, Heinemann L, Place J, Renard E, Scotton R, DeVries JH; AP@home consortium. Patch pump versus conventional pump: postprandial glycemic excursions and the influence of wear time. Diabetes Technol Ther. 2013 Jul;15(7):575-9. doi: 10.1089/dia.2013.0016.

Luijf YM, Mader JK, Doll W, Pieber T, Farret A, Place J, Renard E, Bruttomesso D, Filippi A, Avogaro A, Arnolds S, Benesch C, Heinemann L, DeVries JH; AP@home consortium. Accuracy and reliability of continuous glucose monitoring systems: a head-to-head comparison. Diabetes Technol Ther. 2013 Aug;15(8):722-7. doi: 10.1089/dia.2013.0049.

Arnolds S, Heckermann S, Koch C, Heissmann N, Sawicki PT. How do patients’ preferences compare to the present spectrum of diabetes research? Exp Clin Endocrinol Diabetes. 2013 Jan;121(1):60-3. doi: 10.1055/s-0032-1323776.

2011

Heinemann L, Benesch C, DeVries JH. AP@home: a novel European approach to bring the artificial pancreas home. J Diabetes Sci Technol. 2011 Nov 1;5(6):1363-72.