"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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Health Behavior; Self Efficacy; Type2 Diabetes Mellitus; Type1 Diabetes Mellitus
• Intervention / Treatment: Device: POWER2DM system; Other: Usual care

• Study Type: Interventional
• Enrollment (Actual): 222
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Zuid-Holland
    • Leiden, Zuid-Holland, Netherlands, 2333 ZA
      • Leiden University Medical Centre
• Spain
  • Córdoba, Spain, 14004
    • Reina Sofia University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: POWER2DM support 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.	Device: 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. Power2DM support will be provided as an adjunct to usual care
Active Comparator: Usual care group; Participants in this group will follow their usual diabetes care with their own diabetes care team.	Other: Usual care; Usual care as given to diabetes patients by the patient's diabetes care team.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Leiden University Medical Center
• Collaborators: Andaluz Health Service
• Investigators: Principal Investigator: Jacob Sont, Ph.D., Leiden University Medical Center; Principal Investigator: Javier Delgado Lista, MD Ph.D., Andaluz Health Service

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2018
• Primary Completion (Actual): October 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: May 28, 2018
• First Submitted That Met QC Criteria: July 3, 2018
• First Posted (Actual): July 17, 2018

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Electronic Health (eHealth)
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• Other Study ID Numbers: P17.280

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No