Periodic Reporting for period 3 - POWER2DM (POWER2DM - Predictive model-based decision support for diabetes patient empowerment)
Berichtszeitraum: 2019-02-01 bis 2020-12-31
Diabetes is a chronic disease. Type 1 diabetes (T1DM) is characterized by deficient insulin production and requires daily administration of insulin. Type 2 diabetes (T2DM) results from the body’s ineffective use of insulin and requires lifestyle adjustment and/or oral antidiabetic medication. T2DM comprises 90% of people with diabetes around the world, and is often unnoticed until late stage, once complications have already arisen.
A raised blood sugar is a common effect of uncontrolled diabetes and over time leads to serious damage to many of the body's systems, especially the nerves, blood vessels, eyes and kidney. In 2010, there were approximately 285 million people in the world diagnosed with T2DM. In 2012, diabetes was the direct cause of 1.5 million deaths.
There is an urgent need to develop cost-effective intervention strategies for diabetes. Given the enormous scale of the problem, and the fact that such a large percentage of T2DM cases arise due to an unhealthy lifestyle, personalized care systems that include innovative self-management support strategies, well-linked to the medical care of patients, are of prime importance.
The main objective of POWER2DM is to develop and validate a personalized self-management support system (SMSS) for T1 and T2 diabetes patients that combines and integrates (1) a decision support system (DSS) based on leading European predictive personalized models for diabetes interlinked with predictive computer models, (2) automated e-coaching functionalities based on Behavioural Change Theories, and (3) real-time Personal Data processing and interpretation.
The results of the SMSS with respect to clinical parameters, awareness, acceptance and empowerment of the patient to participate in the care process will be evaluated in 3 EU countries (see Fig. 1).
The conclusions of the action are:
POWER2DM succeeded in reaching all of its objectives. Inability of 1 pilot site to perform, technical difficulties, additional work for registration as a Class I active Medical Device, and the COVID-19 pandemic posed challenges of which the effect was successfully mitigated by adequate risk management, leading to an extension of the project duration from originally 42 months to 59 months.
A raised blood sugar is a common effect of uncontrolled diabetes and over time leads to serious damage to many of the body's systems, especially the nerves, blood vessels, eyes and kidney. In 2010, there were approximately 285 million people in the world diagnosed with T2DM. In 2012, diabetes was the direct cause of 1.5 million deaths.
There is an urgent need to develop cost-effective intervention strategies for diabetes. Given the enormous scale of the problem, and the fact that such a large percentage of T2DM cases arise due to an unhealthy lifestyle, personalized care systems that include innovative self-management support strategies, well-linked to the medical care of patients, are of prime importance.
The main objective of POWER2DM is to develop and validate a personalized self-management support system (SMSS) for T1 and T2 diabetes patients that combines and integrates (1) a decision support system (DSS) based on leading European predictive personalized models for diabetes interlinked with predictive computer models, (2) automated e-coaching functionalities based on Behavioural Change Theories, and (3) real-time Personal Data processing and interpretation.
The results of the SMSS with respect to clinical parameters, awareness, acceptance and empowerment of the patient to participate in the care process will be evaluated in 3 EU countries (see Fig. 1).
The conclusions of the action are:
POWER2DM succeeded in reaching all of its objectives. Inability of 1 pilot site to perform, technical difficulties, additional work for registration as a Class I active Medical Device, and the COVID-19 pandemic posed challenges of which the effect was successfully mitigated by adequate risk management, leading to an extension of the project duration from originally 42 months to 59 months.
Following the requirement analysis and conceptual design (Fig. 2) for the POWER2DM personalized, integrated SMSS, Prototypes I, II and III as well as the Final Release of POWER2DM were realized.
In these prototypes, all main components of the SMSS were established, tested and implemented, fully integrated with each other. Summarizing, relevant long-term risk scoring models for cardiovascular disease and kidney problems were included, in addition to the KADIS model for short-term glucose management. The Action Plan Engine offers guided goal setting, activity planning, and weekly review functionality. The Communication Engine issues push messages to support the patient based on Behavior Change Techniques. The Personal Data Store (PDS) was established based on technical and functional specifications. The API services for all components to interact with the PDS was established. The POWER2DM Shared Decision Making Application (SDMA), the POWER2DM Mobile App and the POWER2DM web application were developed with functionalities that were continuously expanded in the successive prototype system releases.
The first clinical pilot study (Quantification Campaign) produced a valuable dataset containing large amounts of continuous data for further analyses. It provided valuable insights into self-monitoring issues and the user experience of mHealth devices by patients with type 1 and type 2 diabetes, the effects of intensive self-monitoring of lifestyle factors on glycemic control as well as into the relation between acute psychological stress and glucose variability in patients with type 1 and type 2 diabetes.
A Communication and Dissemination Plan was developed and the Project’s website was constructed.
A working relationship with diabetes patient organisations in Spain and The Netherlands was established and several discussion meetings with patients were held.
An Investigational Medical Device Dossier for the POWER2DM integrated Self Management Support System was established, and POWER2DM was registered as a Class I active medical device.
The POWER2DM system was clinically validated in the Evaluation Campaign (EC). The EC was conducted in The Netherlands and Spain. In total, 226 patients out of 230 planned patients were enrolled from Dec. 2018 through Sept. 2019. Data consisting of Case Report Forms (CRFs), lab data, questionnaire data, data from mHealth devices (Abbott FSL glucose meter and Fitbit activity tracker) and POWER2DM system usage were collected and analyzed.
Clinical results will remain under embargo until published in scientific journals.
POWER2DM formed industry liaisons with Dutch SME’s active in (digital) healthcare by embarking on various joint R&D projects, to create a basis for future implementation of POWER2DM in the Dutch healthcare setting.
The confidential POWER2DM Exploitation Plan and Business Plan were developed and reported to the Commission.
Table 2 includes an overview of POWER2DM Results and their dissemination.
In these prototypes, all main components of the SMSS were established, tested and implemented, fully integrated with each other. Summarizing, relevant long-term risk scoring models for cardiovascular disease and kidney problems were included, in addition to the KADIS model for short-term glucose management. The Action Plan Engine offers guided goal setting, activity planning, and weekly review functionality. The Communication Engine issues push messages to support the patient based on Behavior Change Techniques. The Personal Data Store (PDS) was established based on technical and functional specifications. The API services for all components to interact with the PDS was established. The POWER2DM Shared Decision Making Application (SDMA), the POWER2DM Mobile App and the POWER2DM web application were developed with functionalities that were continuously expanded in the successive prototype system releases.
The first clinical pilot study (Quantification Campaign) produced a valuable dataset containing large amounts of continuous data for further analyses. It provided valuable insights into self-monitoring issues and the user experience of mHealth devices by patients with type 1 and type 2 diabetes, the effects of intensive self-monitoring of lifestyle factors on glycemic control as well as into the relation between acute psychological stress and glucose variability in patients with type 1 and type 2 diabetes.
A Communication and Dissemination Plan was developed and the Project’s website was constructed.
A working relationship with diabetes patient organisations in Spain and The Netherlands was established and several discussion meetings with patients were held.
An Investigational Medical Device Dossier for the POWER2DM integrated Self Management Support System was established, and POWER2DM was registered as a Class I active medical device.
The POWER2DM system was clinically validated in the Evaluation Campaign (EC). The EC was conducted in The Netherlands and Spain. In total, 226 patients out of 230 planned patients were enrolled from Dec. 2018 through Sept. 2019. Data consisting of Case Report Forms (CRFs), lab data, questionnaire data, data from mHealth devices (Abbott FSL glucose meter and Fitbit activity tracker) and POWER2DM system usage were collected and analyzed.
Clinical results will remain under embargo until published in scientific journals.
POWER2DM formed industry liaisons with Dutch SME’s active in (digital) healthcare by embarking on various joint R&D projects, to create a basis for future implementation of POWER2DM in the Dutch healthcare setting.
The confidential POWER2DM Exploitation Plan and Business Plan were developed and reported to the Commission.
Table 2 includes an overview of POWER2DM Results and their dissemination.
Progress beyond state-of-the-art:
POWER2DM will extend the following existing methods and tools (see Table 1):
• MT2D-Marvel model for mid-term predictions from Mission-T2D (www.mission-t2d.eu);
• KADIS® tool to provide predictions and treatment simulations for daily glucose management;
• EMPOWER Action Plan Engine (https://www.empower-fp7.eu/)
Expected results:
1 - A personalized, integrated SMSS that offers action (care) plans in terms of changes in lifestyle, nutrition, physical activity and therapy adjustment for short term optimal metabolic control, medium term prevention of deterioration and long term avoidance of diabetes complications.
2 - A patient-targeted decision support system (DSS) by utilizing and interlinking predictive models for the short- (KADIS), mid- (MT2D-Marvel), and long-term (risk score models).
3 - An innovative Action Plan Engine building on EMPOWER, for personalized adaptive computer-aided health behaviour change interventions to support the patient to obtain and maintain healthy behaviour change.
4 - A cloud-based Data Integration Platform to collect and process the patient data coming from personal health systems, wearable sensors and mobile self-monitoring device in real time; facilitated by a well-defined data model and API.
5 - Validation proof of the integrated SMSS system in terms of health outcomes, adherence to care programmes, acceptance of the new organizational process including the ICT components by care providers.
6 - A mobile interface to the POWER2DM SMSS for use on smart phones and tablets.
Socio-economic impact:
POWER2DM’s expected outcomes and socio-economic impact are depicted in Fig. 3.
Wider societal impacts:
POWER2DM, by improving individual self-control of health and of disease prevention, will create healthier lives and thereby more productive societies.
POWER2DM‘s innovative preventive diabetes care model will lead to optimization of the utilization of European healthcare resources. The tele-monitoring based self-care model will reduce the burden on acute healthcare workers, and will improve access to care of patients living in rural and remote areas.
POWER2DM will extend the following existing methods and tools (see Table 1):
• MT2D-Marvel model for mid-term predictions from Mission-T2D (www.mission-t2d.eu);
• KADIS® tool to provide predictions and treatment simulations for daily glucose management;
• EMPOWER Action Plan Engine (https://www.empower-fp7.eu/)
Expected results:
1 - A personalized, integrated SMSS that offers action (care) plans in terms of changes in lifestyle, nutrition, physical activity and therapy adjustment for short term optimal metabolic control, medium term prevention of deterioration and long term avoidance of diabetes complications.
2 - A patient-targeted decision support system (DSS) by utilizing and interlinking predictive models for the short- (KADIS), mid- (MT2D-Marvel), and long-term (risk score models).
3 - An innovative Action Plan Engine building on EMPOWER, for personalized adaptive computer-aided health behaviour change interventions to support the patient to obtain and maintain healthy behaviour change.
4 - A cloud-based Data Integration Platform to collect and process the patient data coming from personal health systems, wearable sensors and mobile self-monitoring device in real time; facilitated by a well-defined data model and API.
5 - Validation proof of the integrated SMSS system in terms of health outcomes, adherence to care programmes, acceptance of the new organizational process including the ICT components by care providers.
6 - A mobile interface to the POWER2DM SMSS for use on smart phones and tablets.
Socio-economic impact:
POWER2DM’s expected outcomes and socio-economic impact are depicted in Fig. 3.
Wider societal impacts:
POWER2DM, by improving individual self-control of health and of disease prevention, will create healthier lives and thereby more productive societies.
POWER2DM‘s innovative preventive diabetes care model will lead to optimization of the utilization of European healthcare resources. The tele-monitoring based self-care model will reduce the burden on acute healthcare workers, and will improve access to care of patients living in rural and remote areas.