"POWER2DM Evaluation Campaign"

Diabetes Mellitus Clinical Trial

— POWER2DMEC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03588104
• Other study ID #: P17.280
• Status: Completed
• Phase: N/A
• Start date: December 3, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2024
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: December 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Health Behavior
• Self Efficacy
• Type1 Diabetes Mellitus
• Type2 Diabetes Mellitus

Intervention

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

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

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Centre	Leiden	Zuid-Holland
Spain	Reina Sofia University Hospital	Córdoba

Sponsors (2)

Lead Sponsor	Collaborator
Leiden University Medical Center	Andaluz Health Service

Countries where clinical trial is conducted

Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Standard deviation of MBG (SDBG)	As derived from continuous glucose measurements by a FGM device	0 weeks, 11 weeks, 22 weeks and 37 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Time spent in range	As derived from continuous glucose measurements by a FGM device	0 weeks, 11 weeks, 22 weeks and 37 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Self-reported exercise time	Exercise time per week as reported in the POWER2DM system	0 weeks, 11 weeks, 22 weeks and 37 weeks
Secondary	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
Secondary	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
Secondary	Weight	Weight in kilograms measured on a scale	0 weeks, 11 weeks, 22 weeks and 37 weeks
Secondary	Body mass index (BMI)	BMI in kg/m2, computed from height and weight	0 weeks, 11 weeks, 22 weeks and 37 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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