Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT04880005

Digital Individualized and Collaborative Treatment of T2D in General Practice Based on Decision Aid

Led by University of Southern Denmark · Updated on 2025-09-02

400

Participants Needed

1

Research Sites

239 weeks

Total Duration

On this page

Sponsors

U

University of Southern Denmark

Lead Sponsor

S

Steno Diabetes Center Odense

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this project is to improve life of patients with type 2 diabetes through an IT-supported lifestyle and treatment intervention. The intervention is based on combining and adapting existing and effective elements into the IT system of the general practitioner. In this way we will integrate specialist supervised treatment in general practice, individual patient coaching, and improved information exchange and data mining. The DICTA intervention consists of two integrated components: a patient-directed eHealth lifestyle coaching program delivered via the LIVA application, and a clinician-directed CDS tool embedded into the EPJ system. 1. eHealth lifestyle coaching: Individuals with T2D in the intervention group will receive individualized digital coaching from a health coach through the LIVA application. PROs are shared with GPs and health staff via the EPJ, enabling tailored, data-driven lifestyle support. 2. CDS: GPs receive real-time, individualized, algorithm-based pharmacological treatment recommendations for managing T2D, hypertension, and hypercholesterolemia, as appropriate. This is expected to facilitate use, assure individually tailored solutions, optimize treatment effects, and strengthen patient engagement. The study is a randomized controlled trial (RCT). It will include 400 patients with newly diagnosed type 2 diabetes. The patients will receive either treatment based on the intervention or usual care. After one year, we will assess quality of life and cardiovascular risk factors in both groups and evaluate if one group has improved management of their type 2 diabetes compared to the other. If the intervention proves effective, implementation on a national scale is highly feasible, and the intervention could probably be adapted to other lifestyle-related chronic diseases in Denmark and in other countries.

CONDITIONS

Official Title

Digital Individualized and Collaborative Treatment of T2D in General Practice Based on Decision Aid

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with type 2 diabetes for up to 10 years
  • Aged between 18 and 80 years
  • Access to internet at home via computer or smartphone
  • Willing to participate and complete the initial questionnaire
Not Eligible

You will not qualify if you...

  • Failure to complete the initial questionnaire
  • No internet access at home through computer or smartphone
  • Currently pregnant or actively trying to get pregnant
  • Having a serious or life-threatening disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Research Unit for General Practice, Department for Public Health, University of Southern Denmark

Odense, Region Syddanmark, Denmark

Actively Recruiting

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Research Team

C

Carl J Brandt, PhD

CONTACT

M

Michael Olesen, Prof.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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