Clinical trial NCT03588104: "POWER2DM Evaluation Campaign"
Official title: Evaluation of the POWER2DM Diabetes Self-Management Support System Compared With Usual Care for Patients With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type1 Diabetes Mellitus
Type2 Diabetes Mellitus
Diabetes Mellitus
Health Behavior
Self Efficacy
Keywords: Electronic Health (eHealth)
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Andaluz Health Service
First posted: 2018-07-17
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic randomised trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in glycemic control
timeFrame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Secondary outcomes:
measure: Amount hypoglycemia
timeFrame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
measure: Hypo unawareness
timeFrame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
measure: Incidence of adverse events
timeFrame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
measure: Mean blood glucose (MBG)
timeFrame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
measure: Standard deviation of MBG (SDBG)
timeFrame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
measure: Largest amplitude of glycemic excursions (LAGE)
timeFrame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
measure: Mean amplitude of glycemic excursions (MAGE)
timeFrame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
measure: Absolute means of daily differences (MODD)
timeFrame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
measure: Time spent in range
timeFrame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
measure: ADVANCE Cardiovascular risk
timeFrame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
measure: ADVANCE Kidney disease Risk
timeFrame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
measure: Major Outcomes T1D
timeFrame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
measure: UKPDS risk score
timeFrame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
measure: Q score
timeFrame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
measure: Amount of steps
timeFrame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
measure: Self-reported exercise time
timeFrame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
measure: Frequency of self-monitoring of blood glucose (SMBG) measurements
timeFrame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
measure: Self-reported adherence to medication plan
timeFrame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
measure: Weight
timeFrame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
measure: Body mass index (BMI)
timeFrame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
measure: Diabetes Self-Management Questionnaire Revised (DSMQ-R)
timeFrame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
measure: Patient utilities by EQ-5D
timeFrame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
measure: Problem Areas in Diabetes (PAID)
timeFrame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
measure: Mood/Well-being by WHO-5 and Patient Health Questionnaire (PHQ-9)
timeFrame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
measure: Technology Acceptance Questionnaire (TAQ)
timeFrame: 5 weeks and 37 weeks
measure: Cost-effectiveness
timeFrame: Over 37 weeks
measure: Stress by perceived Stress Scale (PSS)
timeFrame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
measure: Patient Assessment of Chronic Illness Care (PACIC)
timeFrame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Centre
state: Zuid-Holland
city: Córdoba
country: Spain
facility: Reina Sofia University Hospital
Study officials:
affiliation: Leiden University Medical Center
name: Jacob Sont, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Andaluz Health Service
name: Javier Delgado Lista, MD Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: