"POWER2DM Evaluation Campaign" (POWER2DMEC)

Evaluation of the POWER2DM Diabetes Self-Management Support System Compared With Usual Care for Patients With Diabetes

Rationale: Hyperglycaemia is an important cause of long-term macro-and microvascular complications in all patients with diabetes mellitus. However, only a small fraction of the patients with diabetes reaches the set target of glycemic control. Problems with adequate self-management usually underlie problems to maintain glycaemic control. Thus, patients need more support in order to reduce the burden and increase the effectiveness of their diabetes self-management. One way to do this is by using integrated technologies and personalized plans for diabetes care. For this purpose, the POWER2DM support system was developed to give patients insight into their condition and support diabetes patients and their health care professionals in setting and achieving self-management goals using predictive computer model simulations and behavioural action plans. Objective: To provide proof of concept that POWER2DM is safe and effective in improving glycaemic control, improving behavioural/psychosocial and lifestyle markers, and to assess the cost-effectiveness of the approach and to highlight any potential issues that may impede implementation. Study design: This is a pragmatic randomised controlled trial with 9 months follow-up in which patients will be randomised 1:1 to either Power2DM support (Power2DM group) or usual care (usual care group). There will be evaluation moments at baseline, after 11 weeks, 22 weeks and 37 weeks. Study population: 230 patients with diabetes (N=115 type 1 diabetes (T1D), N=115 type 2 diabetes (T2D)) recruited from out-patient clinics in the Netherlands (Leiden University Medical Centre and affiliating teaching hospitals N=115) and Córdoba, Spain (Reina Sofia University Hospital N=115). Intervention: The POWER2DM support group will receive access to the prototype 2 of the POWER2DM system. This system consists of two components: 1) the web-based Shared Decision Making Dashboard, used to set self-management goals together with a health care professional with the use of both short- and long-term predictive computer simulation models, and 2) the POWER2DM Self-Management Support System as a mobile application and webpage, used to support behavioural change in DM self-management. The system is fed with data from an activity tracker, a glucose monitor and manual data entry. Main study parameters/endpoints: Change in glucose regulation as measured by %HbA1c before and after the intervention compared between the intervention and control group.

Participants in this group will receive access to the POWER2DM system as an adjunct to usual care. The participants have three intervention visits in which they will use the Shared Decision Making Dashboard to set self-management goals and will use the Self-Management Support system for trying to reach those goals in the periods after the intervention visits.

This system consists of two components: 1) the web-based Shared Decision Making Dashboard, used to set self-management goals together with a health care professional with the use of both short- and long-term predictive computer simulation models, and 2) the POWER2DM Self-Management Support System as a mobile application and webpage, used to support behavioural change in DM self-management. The system is fed with data from an activity tracker, a glucose monitor and manual data entry. Power2DM support will be provided as an adjunct to usual care

Change in HbA1c before and after the intervention compared between the intervention and control group

Amount of hypoglycemia measured by time spent in hypoglycaemia before and after treatment in the Power2DM group compared to the usual care control group

Hypo unawareness as measured by Clarke's hypo unawareness questionnaire, before and after treatment in the Power2DM group compared to the usual care control group

The ADVANCE Cardiovascular Risk Engine, calculates the risk of major cardiovascular disease in patients with type 2 diabetes for the next 4 years (range 0-100%). This is defined as fatal or non-fatal myocardial infarction, stroke or cardiovascular death.

The ADVANCE Kidney Risk Engine, calculates the risk of new-onset albuminuria and major kidney-related events in patients with type 2 diabetes for the next 5 years (range 0-100%). Major kidney-related events are defined as doubling of serum creatinin to >2.26mg/dL, renal replacement therapy, or renal death.

The Major Outcomes T1D risk score assess the 3, 5 and 7 year risk of a patient with type 1 diabetes on major outcomes (range 0-100%). These outcomes included major coronary heart disease, stroke, end-stage renal failure, amputations, blindness and all-cause death.

The UKPDS risk score calculated the risk a patient with type 2 diabetes will develop coronary heart disease, fatal coronary hear disease, stroke or fatal stroke (range 0-100%)

The Q score is a single metric for a continuous glucose monitoring (CGM) profile which summarize the glucose profile using five factors: central tendency, hyperglycemia, hypoglycemia, intra- and inter daily variations.

Subscales: Glucose Management, Dietary Control, Physical Activity, Health Care Use Transformed scale scores can vary between 0-10, with higher scores indicating more effective self-care

No subscales: EQ-5D provides a general health index with higher scores indicating better general health. QALYs will be calculated from EQ-5D scores.

The PAID provides a total diabetes distress score (0-100), with higher scores (> 40) indicating more distress.

WHO-5 provides a total score (0-100) with higher scores indicating better wellbeing, PHQ-9 provides a total score (1-27) indicating a likelihood of depression, with higher scores indicating more depressive symptoms

The TAQ provides scores (1-7) on the following domains: Performance expectancy, Effort expectancy, Social influence, Facilitating conditions, Affect, Self-efficacy, Trust, Motivation and Behavioural intention. Higher scores indicate better acceptance of the system.

Costs/quality adjusted life years (QALYs) Costs assessed via cost questionnaire and medication registry. QALYs based on patient utilities measured via EQ5D.

The PSS provides a total perceived stress score (0-40), with higher scores indicating more perceived stress.

Inclusion Criteria: Diagnosed T2DM or T1DM Able to self-monitor and work with computer and smart phone with internet connections (as assessed by researcher) Exclusion Criteria: Severe renal insufficiency (eGFR<30ml/min) Serious/severe comorbidity that interferes with diabetes outcomes or diabetes self-management including but not limited to: psychiatric diseases, chronic hepatopathy, active malignancy, chronic obstructive pulmonary disease (COPD), disease of the digestive tract, endocrine disorders, cerebrovascular disease with disability For female participants: pregnancy or wanting to become pregnant in the coming 9 months Concurrent participation in other clinical trials Any other situation in which the investigator identifies a potential risk of not being able to perform the study.