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NCT04880005Recruiting

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

Protocol for the Digital, Individualized, and Collaborative Treatment of Type 2 Diabetes in General Practice Based on Decision Aid (DICTA) - A Randomized Controlled Trial

Source: ClinicalTrials.gov · Last updated 2 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
400 (estimated)
First submitted
15 Mar 2021
Start date
1 Jun 2021
Primary completion date
31 Aug 2025
Lead sponsor
University of Southern Denmark
NCT number
NCT04880005

What you commit to

  • Study type: Interventional
  • Planned participants: 400
  • From 1 Jun 2021 to the primary completion date, 31 Aug 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Has a serious or life-threatening disease

Other

  • Fails to complete the initial questionnaire
  • No Internet access in own home through computer or smart phone
  • Is pregnant or actively trying to get pregnant

Who the study is looking for

  • Diabetes type 2 in up to 10 years

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

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

This page is information, not medical advice. Discuss any trial with your doctor.