"POWER2DM Evaluation Campaign"

NCT03588104 | Completed

• 1 other identifier: P17.280
• Study Type: interventional
• Target: 222
• Locations: 2 countries
• Sites: 2

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

Keywords

Electronic Health (eHealth)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (28)

• Amount hypoglycemia

  0 weeks, 11 weeks, 22 weeks and 37 weeks

• Hypo unawareness

  0 weeks, 11 weeks, 22 weeks and 37 weeks

• Incidence of adverse events

  0 weeks, 11 weeks, 22 weeks and 37 weeks

• Mean blood glucose (MBG)

  0 weeks, 11 weeks, 22 weeks and 37 weeks

• Standard deviation of MBG (SDBG)

  0 weeks, 11 weeks, 22 weeks and 37 weeks

Study Arms (2)

POWER2DM support group

EXPERIMENTAL

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

Usual care group

ACTIVE COMPARATOR

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

Other: Usual care

Interventions

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

POWER2DM support group

Usual care OTHER

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

Usual care group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed T2DM or T1DM
• Able to self-monitor and work with computer and smart phone with internet connections (as assessed by researcher)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Andaluz Health Service: collaborator

Study Sites (2)

Leiden University Medical Centre

Leiden, South Holland, 2333 ZA, Netherlands

Location

Reina Sofia University Hospital

Córdoba, 14004, Spain

Location

Related Publications (1)

• 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.

  PMID: 37775611 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Health Behavior

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• Jacob Sont, Ph.D.

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

• Javier Delgado Lista, MD Ph.D.

  Andaluz Health Service

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, associate professor

Model Details: Pragmatic randomised trial

Study Record Dates

• First Submitted: May 28, 2018
• First Posted: July 17, 2018
• Study Start: December 3, 2018
• Primary Completion: October 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

ES (1); NL (1)