"POWER2DM Evaluation Campaign"

NCT ID: NCT03588104

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 222 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-03
• Study Completion Date: 2020-12-31

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.

Conditions

Type1 Diabetes Mellitus; Type2 Diabetes Mellitus; Diabetes Mellitus; Health Behavior; Self Efficacy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

POWER2DM system

Intervention Type: 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 group

Participants in this group will follow their usual diabetes care with their own diabetes care team.

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

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

Interventions

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

Intervention Type: DEVICE

Usual care

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Andaluz Health Service

OTHER_GOV

Sponsor Role: collaborator

Leiden University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

JKSont

Principal investigator, associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jacob Sont, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

Javier Delgado Lista, MD Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Andaluz Health Service

Locations

Leiden University Medical Centre

Leiden, South Holland, Netherlands

Reina Sofia University Hospital

Córdoba, , Spain

Countries

Netherlands; Spain

References

Ruissen MM, Torres-Pena JD, Uitbeijerse BS, Arenas de Larriva AP, Huisman SD, Namli T, Salzsieder E, Vogt L, Ploessnig M, van der Putte B, Merle A, Serra G, Rodriguez G, de Graaf AA, de Koning EJP, Delgado-Lista J, Sont JK; POWER2DM Consortium. Clinical impact of an integrated e-health system for diabetes self-management support and shared decision making (POWER2DM): a randomised controlled trial. Diabetologia. 2023 Dec;66(12):2213-2225. doi: 10.1007/s00125-023-06006-2. Epub 2023 Sep 29.

Reference Type: DERIVED

PMID: 37775611 (View on PubMed)

Other Identifiers

P17.280

Identifier Type: -

Identifier Source: org_study_id