Close the loop in diabetes care
Artificial pancreas systems are medical products that use algorithms informed by continuous glucose monitoring (CGM) data of a given patient, thereby regulating the rates of a continuous subcutaneous insulin infusion through an insulin pump. In this way, artificial pancreas systems are taking over control of the patient’s blood glucose levels.
Artificial pancreas initiatives in type 1 diabetes
In the last ten years, tremendous progress has been made in the clinical validation of automated insulin delivery by means of artificial pancreas systems for people with type 1 diabetes (T1D). Many artificial pancreas initiatives are/were driven by academic type of research groups, often in collaboration with partners from industry. For instance, the large AP@home project was coordinated by the Academic Medical Center Amsterdam and Profil [1,2]. The AP@home consortium provided one of the longest real-life artificial pancreas experiences by investigating 12 weeks of unsupervised artificial pancreas usage in adolescents and adults with T1D [3]. Also national research institutions such as CEA-Leti (Laboratoire d'electronique des technologies de l'information - Laboratoire d'electronique des technologies de l'information) [4] and the National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK) [5], play important roles in the development of artificial pancreas systems as do public-private partnerships such as the JDRF [6] and EIT Health [7]. Until today the EIT Health Knowledge and Innovation Community has implemented two artificial pancreas projects, CLOSE [8] and Diabeloop for Kids (D4KIDS) [9].
Today, in Europe both the MiniMed 670G and the Diabeloop DBLG1 hybrid artificial pancreas systems were granted marketing authorization for treating adults with T1D.
Artificial pancreas in type 2 diabetes - objectives and scopes
Clinical trials in people with type 2 diabetes (T2D) indicated feasibility and safety of artificial pancreas systems also in people with type 2 diabetes [10,11,12].
Objectives and scope of artificial pancreas usage in T2D may vary according to the diversity of people with T2D and their needs and requirements [13]. Introduction of the artificial pancreas early after diagnosis might facilitate the transition to insulin therapy thereby helping to delay the decline of beta cell function and the onset of clinically overt diabetes complications. People with T2D already on insulin pump therapy might have a particularly positive attitude towards artificial pancreas usage. For them the artificial pancreas could be perceived as a logical and consistent enhancement of insulin pump functionalities. Probably some people on insulin pump therapy will show additional benefit from the transition to an artificial pancreas system in terms of glycemic control. In the management of people with advanced T2D and elderly people with T2D artificial pancreas usage could be expected to relieve users and caregivers from the burden associated with insulin administration. Here the artificial pancreas usage might protect people from frailty, disability, and disease aggravation related to unrecognized episodes of massive dysglycemia. This could translate into lower rates of avoidable hospitalizations for actually ambulatory care-sensitive conditions – a well-recognized cost driver with a high impact on life quality for people with diabetes and their loved ones.
CLOSE - Automated Glucose Control at Home for People with Chronic Disease
The pan-European CLOSE project [13] is part of the EIT Health innovation project portfolio. The CLOSE consortium is aiming to develop integrated artificial pancreas solutions (APplus) for people with T2D. APplus means a comprehensive product and service package, adding education and trainings, outcome predictors and performance indicators as well as telemedical services to the artificial pancreas device.
When developing APplus CLOSE follows a co-creative approach in the specific framework of French homecare service provision. French homecare service provider operate fully integrated chronic care platforms at the crossroads between patients, health professionals, payers, and prescribers. French homecare service provision seems to be a real-world environment particularly suitable as a learning lab for co-creating an APplus solution meeting the needs and requirements of patients, payers and caregiver teams. Here learnings about the different stakeholders’ perceptions of diabetes, their attitudes towards diabetes management, and their understanding of treatment success can immediately inform the customization of APplus packages.
For a wider distribution of artificial pancreas usage, it seems reasonable to assume that APplus should be highly adaptable to the requirements of different T2D patient sub-groups and their specific care situations. This calls for an APplus portfolio containing an array of artificial pancreas systems e.g. with and without carbohydrate counting and realizing different intensities of insulin therapy and degrees of automation.
APplus: scalability and enhancement
Comprehensive solutions such as APplus bear potentials for massive and multidimensional scalability and enhancement [13]. Using homecare as a starting point APplus could be expanded to operation in assisted living facilities, nursing homes, and hospitals. Also APplus solutions for people having T2D without overt comorbid conditions or T1D are under consideration. Geographical upscaling should seek benefit from collaboration with regions and municipalities in a careful consideration of existing local/national competencies, healthcare structures and payment models. An obligatory delivery of train-the-trainer programs would grow a network of certified caregivers guaranteeing a safe and cost effective implementation of artificial pancreas solutions around Europe and globally. Beyond technical adaptations, the design of highly targeted training modules is predicted to be a main differentiator of APplus solutions tailored to the needs and requirements of different patient groups and care environments. Adding capabilities for the exploitation of patient-generated health and behavioral data will functionally enhance the artificial pancreas in the medium term. The utilization of self-learning algorithms and an increased interconnectedness with health and social service provision will close the loop between the users’ state of health and customized care provision in a more comprehensive meaning. Converging with other strands of health innovations in chronic care enhanced artificial pancreas systems will contribute to a fully integrated personalized diabetes management.
From the previous CLOSE investigations into stakeholder attitudes, it became clear that physicians and patients see a high need for a continuous further development of the artificial pancreas. An artificial pancreas system focusing on the closed-loop control of blood glucose levels is considered a transition technology towards a much more comprehensive predictive decision support based on further advanced control algorithms.
This scenario matches the outcome of the CDTM Trend Seminar on “Digital Innovation in Diabetes Care” co-organized by CLOSE [14]. Here artificial pancreas operation is predicted to become gradually integrated as part of an interconnected ecosystem of digital health and social care. A comprehensive monitoring of metabolic signatures and parameters reflecting patterns of everyday behavior would produce a huge amount of real‐world data, which could be processed by self-learning control algorithms using artificial intelligence tools. The outcome should trigger an adjustment of therapies, treatments and behavioral patterns, which again would feed back to the captured parameters.
Closing control loops and gradually optimizing disease management in a personalized way is going to realize the twin objective of optimizing everyday metabolic control and re‐adapting behavioral habits to prolong the patients’ independency and prevent the development of frailty, disability and comorbid conditions.