Clinical impact of an integrated e-health system for diabetes self-management support and shared decision making (POWER2DM): a randomised controlled trial.

AIMS/HYPOTHESIS: There is a lack of e-health systems that integrate the complex variety of aspects relevant for diabetes self-management. We developed and field-tested an e-health system (POWER2DM) that integrates medical, psychological and behavioural aspects and connected wearables to support patients and healthcare professionals in shared decision making and diabetes self-management. METHODS: Participants with type 1 or type 2 diabetes (aged >18 years) from hospital outpatient diabetes clinics in the Netherlands and Spain were randomised using randomisation software to POWER2DM or usual care for 37 weeks. This RCT assessed the change in HbA1c between the POWER2DM and usual care groups at the end of the study (37 weeks) as a primary outcome measure. Participants and clinicians were not blinded to the intervention. Changes in quality of life (QoL) (WHO-5 Well-Being Index [WHO-5]), diabetes self-management (Diabetes Self-Management Questionnaire - Revised [DSMQ-R]), glycaemic profiles from continuous glucose monitoring devices, awareness of hypoglycaemia (Clarke hypoglycaemia unawareness instrument), incidence of hypoglycaemic episodes and technology acceptance were secondary outcome measures. Additionally, sub-analyses were performed for participants with type 1 and type 2 diabetes separately. RESULTS: A total of 226 participants participated in the trial (108 with type 1 diabetes; 118 with type 2 diabetes). In the POWER2DM group (n=111), HbA1c decreased from 60.6±14.7 mmol/mol (7.7±1.3%) to 56.7±12.1 mmol/mol (7.3±1.1%) (means ± SD, p<0.001), compared with no change in the usual care group (n=115) (baseline: 61.7±13.7 mmol/mol, 7.8±1.3%; end of study: 61.0±12.4 mmol/mol, 7.7±1.1%; p=0.19) (between-group difference 0.24%, p=0.008). In the sub-analyses in the POWER2DM group, HbA1c in participants with type 2 diabetes decreased from 62.3±17.3 mmol/mol (7.9±1.6%) to 54.3±11.1 mmol/mol (7.1±1.0%) (p<0.001) compared with no change in HbA1c in participants with type 1 diabetes (baseline: 58.8±11.2 mmol/mol [7.5±1.0%]; end of study: 59.2±12.7 mmol/mol [7.6±1.2%]; p=0.84). There was an increase in the time during which interstitial glucose levels were between 3.0 and 3.9 mmol/l in the POWER2DM group, but no increase in clinically relevant hypoglycaemia (interstitial glucose level below 3.0 mmol/l). QoL improved in participants with type 1 diabetes in the POWER2DM group compared with the usual care group (baseline: 15.7±3.8; end of study: 16.3±3.5; p=0.047 for between-group difference). Diabetes self-management improved in both participants with type 1 diabetes (from 7.3±1.2 to 7.7±1.2; p=0.002) and those with type 2 diabetes (from 6.5±1.3 to 6.7±1.3; p=0.003) within the POWER2DM group. The POWER2DM integrated e-health support was well accepted in daily life and no important adverse (or unexpected) effects or side effects were observed. CONCLUSIONS/INTERPRETATION: POWER2DM improves HbA1c levels compared with usual care in those with type 2 diabetes, improves QoL in those with type 1 diabetes, improves diabetes self-management in those with type 1 and type 2 diabetes, and is well accepted in daily life. TRIAL REGISTRATION: ClinicalTrials.gov NCT03588104. FUNDING: This study was funded by the European Union's Horizon 2020 Research and Innovation Programme (grant agreement number 689444).

FHIR Driven Self-Management Support System for Diabetes.

The number of people with diabetes is increasing in every European country and as with all chronic diseases, coping with diabetes is a long-term process. Self-Management and supporting behaviour change are aspects when dealing with diabetes. The POWER2DM (Funded by the EU Horizon 2020 research and innovation programme under grant agreement No 689444) system combines treatment planning and self-management activities by providing interventions to change a patient's lifestyle towards a healthier, diabetes-appropriate life. FHIR3 allows for data exchange.

Empowering Diabetes Patients with Interventions Based on Behaviour Change Techniques.

The number of people with diabetes is increasing in every European country and like all chronic diseases it cannot be cured. However, patient empowerment is an acknowledged strategy for improving the patients' health situation. This paper describes the Action Plan Engine developed as a tool for diabetes patients in the POWER2DM project. The Action Plan Engine offers a guided workflow based on treatment goals and activities. A periodic review evaluates how successful a patient has fulfilled these goals and activities. Part of the evaluation is detailed feedback, in particular about 170 interventions based on Behaviour Change Techniques in order to change a patient's lifestyle behaviour towards a healthier, diabetes-appropriate lifestyle. Additionally, the Action Plan Engine offers decision trees for coping with barriers regarding glucose monitoring, exercise, carbohydrate, insulin and stress.

Modular ICT-based patient empowerment framework for self-management of diabetes: Design perspectives and validation results.

INTRODUCTION: It is estimated that more than 382 million people suffer from diabetes across the globe, most of which are between the age of 40 and 59 years. ICT can play a key role in better management of diabetes and in patient empowerment. Patient empowerment involves patients to a greater extent in their own healthcare process and disease management becomes an integrated part of their daily life. Self-management opens the possibility for patients to contribute to their own healthcare as well as to be more in control of their disease. OBJECTIVES: The objective of our study was to explore the impact of an ICT-based patient empowerment framework in diabetes self-management. METHODS: A modular patient empowerment framework that fosters diabetes self-management was designed and implemented. The framework incorporates expert knowledge in the form of clinical guidelines, and it supports patients in the specification of personalized activities that are based on medical recommendations and personal goals, and in the collection of observations of daily living. The usability and usefulness of the proposed framework were assessed in a pilot study with the participation of 60 patients and 12 health professionals. RESULTS: The study revealed that a patient empowerment approach based on self-management ICT tools is useful and accepted by both the patients and the physicians. For those patients who were already disciplined in their disease management the piloted solution served as a facilitator for data logging. For the rest, it served as an incentive for better adherence to disease management principles. The ICT tools prompted many patients into becoming more physically active and into making dietary habits' adjustments. However, this impact proved to be tightly correlated with the sociocultural background of the subjects. The study also demonstrated that even in patient-centric self-management interventions the physicians still have a key role to play. However, the acceptance of such interventions by the healthcare professionals depends not only on the level of impact in their patients' disease management but also on the level of impact in their workflow. CONCLUSIONS: It is evident that a patient empowerment approach based on self-management ICT tools is useful and accepted by patients and physicians. Further, there are clear indications that ICT frameworks such as the one presented in this paper support patients in behavioral changes and in better disease management. Finally, it was realized that self-management solutions should be built around the objective not only to educate and guide patients in disease self-management, but also to assist them in exploring the decision space and to provide insight and explanations about the impact of their own values on the decision.