"POWER2DM Evaluation Campaign"
- Conditions
- Type2 Diabetes MellitusSelf EfficacyType1 Diabetes MellitusHealth BehaviorDiabetes Mellitus
- Registration Number
- NCT03588104
- Lead Sponsor
- Leiden University Medical Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 222
- Diagnosed T2DM or T1DM
- Able to self-monitor and work with computer and smart phone with internet connections (as assessed by researcher)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in glycemic control 0 weeks, 11 weeks, 22 weeks and 37 weeks Change in HbA1c before and after the intervention compared between the intervention and control group
- Secondary Outcome Measures
Name Time Method Body mass index (BMI) 0 weeks, 11 weeks, 22 weeks and 37 weeks BMI in kg/m2, computed from height and weight
Time spent in range 0 weeks, 11 weeks, 22 weeks and 37 weeks As derived from continuous glucose measurements by a FGM device
ADVANCE Kidney disease Risk 0 weeks, 11 weeks, 22 weeks and 37 weeks 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.
UKPDS risk score 0 weeks, 11 weeks, 22 weeks and 37 weeks 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%)
Q score 0 weeks, 11 weeks, 22 weeks and 37 weeks 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.
Absolute means of daily differences (MODD) 0 weeks, 11 weeks, 22 weeks and 37 weeks As derived from continuous glucose measurements by a FGM device
ADVANCE Cardiovascular risk 0 weeks, 11 weeks, 22 weeks and 37 weeks 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.
Major Outcomes T1D 0 weeks, 11 weeks, 22 weeks and 37 weeks 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.
Amount of steps 0 weeks, 11 weeks, 22 weeks and 37 weeks Average amount of steps per day over a week measured by a step counter
Amount hypoglycemia 0 weeks, 11 weeks, 22 weeks and 37 weeks Amount of hypoglycemia measured by time spent in hypoglycaemia before and after treatment in the Power2DM group compared to the usual care control group
Incidence of adverse events 0 weeks, 11 weeks, 22 weeks and 37 weeks Incidence of adverse events occurring during the study period including serious hypoglycemic events
Mean amplitude of glycemic excursions (MAGE) 0 weeks, 11 weeks, 22 weeks and 37 weeks As derived from continuous glucose measurements by a FGM device
Self-reported exercise time 0 weeks, 11 weeks, 22 weeks and 37 weeks Exercise time per week as reported in the POWER2DM system
Weight 0 weeks, 11 weeks, 22 weeks and 37 weeks Weight in kilograms measured on a scale
Cost-effectiveness Over 37 weeks Costs/quality adjusted life years (QALYs) Costs assessed via cost questionnaire and medication registry. QALYs based on patient utilities measured via EQ5D.
Standard deviation of MBG (SDBG) 0 weeks, 11 weeks, 22 weeks and 37 weeks As derived from continuous glucose measurements by a FGM device
Frequency of self-monitoring of blood glucose (SMBG) measurements 0 weeks, 11 weeks, 22 weeks and 37 weeks Frequency of SMBG measurements as reported by the glucose measurement device
Patient utilities by EQ-5D 0 weeks, 11 weeks, 22 weeks and 37 weeks No subscales: EQ-5D provides a general health index with higher scores indicating better general health. QALYs will be calculated from EQ-5D scores.
Hypo unawareness 0 weeks, 11 weeks, 22 weeks and 37 weeks 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
Mean blood glucose (MBG) 0 weeks, 11 weeks, 22 weeks and 37 weeks As derived from continuous glucose measurements by a flash glucose monitoring (FGM) device
Largest amplitude of glycemic excursions (LAGE) 0 weeks, 11 weeks, 22 weeks and 37 weeks As derived from continuous glucose measurements by a FGM device
Diabetes Self-Management Questionnaire Revised (DSMQ-R) 0 weeks, 11 weeks, 22 weeks and 37 weeks 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
Mood/Well-being by WHO-5 and Patient Health Questionnaire (PHQ-9) 0 weeks, 11 weeks, 22 weeks and 37 weeks 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
Problem Areas in Diabetes (PAID) 0 weeks, 11 weeks, 22 weeks and 37 weeks The PAID provides a total diabetes distress score (0-100), with higher scores (\> 40) indicating more distress.
Technology Acceptance Questionnaire (TAQ) 5 weeks and 37 weeks 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.
Patient Assessment of Chronic Illness Care (PACIC) 0 weeks, 11 weeks, 22 weeks and 37 weeks The PACIC measures the patient's perception of the care that they receive.
Stress by perceived Stress Scale (PSS) 0 weeks, 11 weeks, 22 weeks and 37 weeks The PSS provides a total perceived stress score (0-40), with higher scores indicating more perceived stress.
Self-reported adherence to medication plan 0 weeks, 11 weeks, 22 weeks and 37 weeks Self-reported adherence to medication plan as reported in the POWER2DM system
Trial Locations
- Locations (2)
Leiden University Medical Centre
🇳🇱Leiden, Zuid-Holland, Netherlands
Reina Sofia University Hospital
🇪🇸Córdoba, Spain
Leiden University Medical Centre🇳🇱Leiden, Zuid-Holland, Netherlands