POWER2DM Evaluation Campaign

Study Overview
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Brief Summary
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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.

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

Conditions
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Type1 Diabetes Mellitus, Type2 Diabetes Mellitus, Diabetes Mellitus, Health Behavior, Self Efficacy

Intervention / Treatment
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* Device: POWER2DM system
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pragmatic randomised trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: POWER2DM support group<br>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. | Device: POWER2DM system<br>* 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<br>|
| Active Comparator: Usual care group<br>Participants in this group will follow their usual diabetes care with their own diabetes care team. | Other: Usual care<br>* Usual care as given to diabetes patients by the patient's diabetes care team.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glycemic control | Change in HbA1c before and after the intervention compared between the intervention and control group | 0 weeks, 11 weeks, 22 weeks and 37 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount hypoglycemia | Amount of hypoglycemia measured by time spent in hypoglycaemia before and after treatment in the Power2DM group compared to the usual care control group | 0 weeks, 11 weeks, 22 weeks and 37 weeks | 
| Hypo unawareness | 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 | 0 weeks, 11 weeks, 22 weeks and 37 weeks | 
| Incidence of adverse events | Incidence of adverse events occurring during the study period including serious hypoglycemic events | 0 weeks, 11 weeks, 22 weeks and 37 weeks | 
| Mean blood glucose (MBG) | As derived from continuous glucose measurements by a flash glucose monitoring (FGM) device | 0 weeks, 11 weeks, 22 weeks and 37 weeks | 
| Standard deviation of MBG (SDBG) | As derived from continuous glucose measurements by a FGM device | 0 weeks, 11 weeks, 22 weeks and 37 weeks | 
| Largest amplitude of glycemic excursions (LAGE) | As derived from continuous glucose measurements by a FGM device | 0 weeks, 11 weeks, 22 weeks and 37 weeks | 
| Mean amplitude of glycemic excursions (MAGE) | As derived from continuous glucose measurements by a FGM device | 0 weeks, 11 weeks, 22 weeks and 37 weeks | 
| Absolute means of daily differences (MODD) | As derived from continuous glucose measurements by a FGM device | 0 weeks, 11 weeks, 22 weeks and 37 weeks | 
| Time spent in range | As derived from continuous glucose measurements by a FGM device | 0 weeks, 11 weeks, 22 weeks and 37 weeks | 
| ADVANCE Cardiovascular risk | 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. | 0 weeks, 11 weeks, 22 weeks and 37 weeks | 
| ADVANCE Kidney disease Risk | 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. | 0 weeks, 11 weeks, 22 weeks and 37 weeks | 
| Major Outcomes T1D | 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. | 0 weeks, 11 weeks, 22 weeks and 37 weeks | 
| UKPDS risk score | 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%) | 0 weeks, 11 weeks, 22 weeks and 37 weeks | 
| Q score | 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. | 0 weeks, 11 weeks, 22 weeks and 37 weeks | 
| Amount of steps | Average amount of steps per day over a week measured by a step counter | 0 weeks, 11 weeks, 22 weeks and 37 weeks | 
| Self-reported exercise time | Exercise time per week as reported in the POWER2DM system | 0 weeks, 11 weeks, 22 weeks and 37 weeks | 
| Frequency of self-monitoring of blood glucose (SMBG) measurements | Frequency of SMBG measurements as reported by the glucose measurement device | 0 weeks, 11 weeks, 22 weeks and 37 weeks | 
| Self-reported adherence to medication plan | Self-reported adherence to medication plan as reported in the POWER2DM system | 0 weeks, 11 weeks, 22 weeks and 37 weeks | 
| Weight | Weight in kilograms measured on a scale | 0 weeks, 11 weeks, 22 weeks and 37 weeks | 
| Body mass index (BMI) | BMI in kg/m2, computed from height and weight | 0 weeks, 11 weeks, 22 weeks and 37 weeks | 
| Diabetes Self-Management Questionnaire Revised (DSMQ-R) | 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 | 0 weeks, 11 weeks, 22 weeks and 37 weeks | 
| Patient utilities by EQ-5D | No subscales: EQ-5D provides a general health index with higher scores indicating better general health. QALYs will be calculated from EQ-5D scores. | 0 weeks, 11 weeks, 22 weeks and 37 weeks | 
| Problem Areas in Diabetes (PAID) | The PAID provides a total diabetes distress score (0-100), with higher scores (> 40) indicating more distress. | 0 weeks, 11 weeks, 22 weeks and 37 weeks | 
| Mood/Well-being by WHO-5 and Patient Health Questionnaire (PHQ-9) | 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 | 0 weeks, 11 weeks, 22 weeks and 37 weeks | 
| Technology Acceptance Questionnaire (TAQ) | 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. | 5 weeks and 37 weeks | 
| Cost-effectiveness | Costs/quality adjusted life years (QALYs) Costs assessed via cost questionnaire and medication registry. QALYs based on patient utilities measured via EQ5D. | Over 37 weeks | 
| Stress by perceived Stress Scale (PSS) | The PSS provides a total perceived stress score (0-40), with higher scores indicating more perceived stress. | 0 weeks, 11 weeks, 22 weeks and 37 weeks | 
| Patient Assessment of Chronic Illness Care (PACIC) | The PACIC measures the patient's perception of the care that they receive. | 0 weeks, 11 weeks, 22 weeks and 37 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electronic Health (eHealth)