Personalized digital and team-based diabetes care in general practice using a decision aid
Official title: Protocol for the Digital, Individualized, and Collaborative Treatment of Type 2 Diabetes in General Practice Based on Decision Aid (DICTA) - A Randomized Controlled Trial
Run by University of Southern Denmark · NCT04880005 · Data updated 2026-11-12
This project will try a combined patient app for individualized lifestyle coaching and a doctor-facing decision support tool to help adults with type 2 diabetes diagnosed within the last 10 years improve weight and self-care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | University of Southern Denmark Academic / other |
| Locations | 1 site (Odense, Region Syddanmark) |
| Status | Recruiting |
| Started | June 1, 2021 |
| Main results expected | August 31, 2025 |
| Study ends | December 30, 2025 |
| Registry record updated | September 2, 2025 |
| Trial ID | NCT04880005 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with type 2 diabetes diagnosed within the past ten years who have internet access, are willing to use a smartphone or computer app, and receive care in participating general practices are ideal candidates.
✕Probably not a fit
Patients who lack home internet or smartphone access, are pregnant or planning pregnancy, or have serious life‑threatening illnesses are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The DICTA program combines a patient-directed eHealth lifestyle coaching app (LIVA) with a clinician-facing clinical decision support (CDS) tool embedded in the electronic patient journal (EPJ) used by general practitioners. Participants receive individualized digital coaching from a health coach through LIVA while patient-reported outcomes and activity data are shared with GPs to enable tailored, data-driven treatment adjustments. The CDS provides real-time, algorithm-based recommendations to clinicians to support medication, lifestyle, and follow-up decisions within routine primary care. The intervention targets adults with type 2 diabetes diagnosed within ten years and excludes those without internet access, pregnant people, or those with serious life-threatening illnesses.
Why it matters
Potential benefit: If successful, this approach could help patients lose weight, improve blood glucose control, and receive more personalized, coordinated care from their GP.
How similar studies have gone: Previous work on intensive weight-loss programs and collaborative eHealth coaching (including Lean et al. 2018, Brandt et al. 2011, and Haste et al. 2017) has shown substantial weight loss and diabetes remission in many participants, supporting this combined approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diabetes type 2 in up to 10 years Exclusion Criteria: * 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 * Has a serious or life-threatening disease
Where it's running
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Research Unit for General Practice, Department for Public Health, University of Southern Denmark
Odense, Region Syddanmark, Denmark Recruiting
Study contacts
- Principal investigator: Jens H Søndergaard — University of Southern Denmark
- Study coordinator: Carl J Brandt, PhD
- Email: cbrandt@health.sdu.dk
- Phone: +45 2014 1566
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.