UK MyREMEDY Clinical Trial, Version 1
Research type
Research Study
Full title
MyDiaMate for Remission of Elevated Diabetes Distress in Type 1 Diabetes (UK MyREMEDY).
IRAS ID
329634
Contact name
Kirsty Winkley
Contact email
Sponsor organisation
King's College London
Clinicaltrials.gov Identifier
RMS360, Funder's reference
Duration of Study in the UK
1 years, 3 months, 1 days
Research summary
One in three persons affected by type 1 diabetes (T1D) report elevated psychological distress, a condition that complicates both daily living and diabetes self-management. Although diabetes distress is associated with elevated HbA1c levels and a higher risk of adverse diabetes-related health complications, people with T1D often have limited access to mental health services. E-mental health, which has advanced significantly in recent years, offers a potential solution. However, while there is an abundance of glucose and lifestyle focused apps (particularly for type 2 diabetes), there is a paucity of digital tools focusing on mental health for T1D. To fill this gap, researchers developed MyDiaMate, a web-based, self-guided programme grounded in principles of Cognitive Behavioural Therapy (CBT). The programme offers several modules centred around common sources of diabetes distress, including the disruptive impact of stress on blood glucose, fear of hypoglycaemia, disordered eating, and fatigue.
This randomized controlled trial seeks to determine the effectiveness of MyDiaMate in adults with T1D across the UK, the Netherlands, Spain, and Germany, specifically assessing improvement of mental health in terms of diabetes distress relative to care as usual (CAU). Adults with T1D and mild to moderate levels of diabetes-related distress will be eligible to participate and will be recruited through diabetes healthcare professionals at Guy's and St Thomas' Hospital NHS Foundation Trust and via social media. Eligible participants will complete three rounds of online, self-reported mental health measurements over six months. Those in the CAU group who wish to do so will be given access to MyDiaMate at the end of the third month. If found effective in the clinical trial, our ultimate aim is to make MyDiaMate widely available in English, Dutch, Spanish, and German, creating the opportunity to assist large groups of adults with T1D in self-managing diabetes distress and improving their mental health.
REC name
London - London Bridge Research Ethics Committee
REC reference
24/LO/0633
Date of REC Opinion
2 Sep 2024
REC opinion
Favourable Opinion