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Completed

NCT Number: NCT03588104

"POWER2DM Evaluation Campaign"

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.

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Key information

Conditions

Type1 Diabetes Mellitus Behavior Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Metabolic Diseases Nutritional and Metabolic Diseases Self Efficacy Type2 Diabetes Mellitus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leiden University Medical Centre, Leiden, South Holland, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

POWER2DM system

Device

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

Usual Care

Other

Usual care as given to diabetes patients by the patient's diabetes care team.

Primary outcomes

  1. Change in glycemic control

    Time frame: 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 outcomes

  1. Amount hypoglycemia

    Time frame: 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

  2. Hypo unawareness

    Time frame: 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

  3. Incidence of adverse events

    Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks

    Incidence of adverse events occurring during the study period including serious hypoglycemic events

  4. Mean blood glucose (MBG)

    Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks

    As derived from continuous glucose measurements by a flash glucose monitoring (FGM) device

  5. Standard deviation of MBG (SDBG)

    Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks

    As derived from continuous glucose measurements by a FGM device

  6. Largest amplitude of glycemic excursions (LAGE)

    Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks

    As derived from continuous glucose measurements by a FGM device

  7. Mean amplitude of glycemic excursions (MAGE)

    Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks

    As derived from continuous glucose measurements by a FGM device

  8. Absolute means of daily differences (MODD)

    Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks

    As derived from continuous glucose measurements by a FGM device

  9. Time spent in range

    Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks

    As derived from continuous glucose measurements by a FGM device

  10. ADVANCE Cardiovascular risk

    Time frame: 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.

  11. ADVANCE Kidney disease Risk

    Time frame: 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.

  12. Major Outcomes T1D

    Time frame: 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.

  13. UKPDS risk score

    Time frame: 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%)

  14. Q score

    Time frame: 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.

  15. Amount of steps

    Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks

    Average amount of steps per day over a week measured by a step counter

  16. Self-reported exercise time

    Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks

    Exercise time per week as reported in the POWER2DM system

  17. Frequency of self-monitoring of blood glucose (SMBG) measurements

    Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks

    Frequency of SMBG measurements as reported by the glucose measurement device

  18. Self-reported adherence to medication plan

    Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks

    Self-reported adherence to medication plan as reported in the POWER2DM system

  19. Weight

    Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks

    Weight in kilograms measured on a scale

  20. Body mass index (BMI)

    Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks

    BMI in kg/m2, computed from height and weight

  21. Diabetes Self-Management Questionnaire Revised (DSMQ-R)

    Time frame: 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

  22. Patient utilities by EQ-5D

    Time frame: 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.

  23. Problem Areas in Diabetes (PAID)

    Time frame: 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.

  24. Mood/Well-being by WHO-5 and Patient Health Questionnaire (PHQ-9)

    Time frame: 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

  25. Technology Acceptance Questionnaire (TAQ)

    Time frame: 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.

  26. Cost-effectiveness

    Time frame: 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.

  27. Stress by perceived Stress Scale (PSS)

    Time frame: 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.

  28. Patient Assessment of Chronic Illness Care (PACIC)

    Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks

    The PACIC measures the patient's perception of the care that they receive.

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Collaborators

  • Andaluz Health Service

Registry information

Official study title

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

Acronym: POWER2DMEC

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 17, 2018
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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