Using MyDiaMate app to help adults with type 1 diabetes manage mental health
MyDiaMate For Remission Of Diabetes Distress In Type 1 Diabetes (MyREMEDY): A Multi-National Randomised-Controlled Trial
This study is testing if the MyDiaMate app can help adults with type 1 diabetes feel better mentally compared to just getting regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 660 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Amsterdam UMC, location VUmc Academic / other |
| Locations | 4 sites (Bad Mergentheim, Baden-Württemberg and 3 other locations) |
| Trial ID | NCT06308549 on ClinicalTrials.gov |
What this trial studies
The MyREMEDY study investigates the effectiveness of the MyDiaMate self-help application in improving mental health for adults with type 1 diabetes experiencing diabetes distress. This multinational randomized-controlled trial compares the app's impact against standard care across four countries: the Netherlands, the United Kingdom, Spain, and Germany. Participants will either use the MyDiaMate app for three months or receive usual care, with assessments conducted to measure changes in mental health. The study aims to provide accessible support for individuals managing the psychological burdens of living with diabetes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of type 1 diabetes for at least six months who experience diabetes distress.
Not a fit: Patients with recent psychiatric disorders, suicidality, or those who have started psychotropic medication in the past three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the mental well-being of adults with type 1 diabetes, reducing distress and enhancing their quality of life.
How similar studies have performed: Other studies have shown promise in using digital health interventions for mental health support in chronic conditions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * At least 18 years old at signing the informed consent form * Type 1 diabetes diagnosis at least 6 months ago * Having access to the internet and a smartphone/tablet/laptop'/computer for the entire time of study participation * Experiencing diabetes distress (checked during a phone call between research assistant and participant. The condition is met if the participant has an average score of ≥2 on the 2-item Diabetes Distress Scale (DDS-2), representing clinically meaningful diabetes distress) Exclusion Criteria: * Having been diagnosed with a psychiatric disorder in the past 6 months for which the person is under psychological/psychiatric treatment * Suicidality * Having started a treatment with psychotropic medication in the past 3 months * Illiteracy * Experience of cognitive problems that hamper using MyDiaMate or vision/auditory problems that are hindering in daily life * Prior use of MyDiaMate (only applicable to participants in the Netherlands)
Where this trial is running
Bad Mergentheim, Baden-Württemberg and 3 other locations
- Forschungsinstitut Diabetes-Akademie Bad Mergentheim — Bad Mergentheim, Baden-Württemberg, Germany (Recruiting)
- Amsterdam UMC — Amsterdam, Noord-Holland, Netherlands (Recruiting)
- Universidad de Málaga — Málaga, Spain (Not_yet_recruiting)
- King's College London — London, United Kingdom (Not_yet_recruiting)
Study contacts
- Principal investigator: Maartje de Wit, Dr. — Amsterdam UMC, location VUmc
- Study coordinator: Theresa Mohr, Msc
- Email: myremedy@amsterdamumc.nl
- Phone: +3120444444
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.