Status:
RECRUITING
Optimising the Delivery of Diabetes Distress Informed Care for Its Prevention, Detection, and Management in Adults With Type 1 Diabetes: a Feasibility Study (D-stress Study)
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Conditions:
Diabetes Type 1
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Up to one in two adults with type 1 diabetes find living with and managing diabetes to be emotionally challenging. This 'emotional side' of diabetes - feeling worried, frustrated, overwhelmed, sad, bu...
Eligibility Criteria
Inclusion
- Adults with type 1 diabetes
- People aged 18 years old and older
- With a T1DM diagnosis of more than one year
- Who used a Continuous Glucose Monitoring device 3 months prior to trial entry
- Health care professionals
- Members of the multidisciplinary diabetes team
- Who would like and be able to undertake training in Enhanced Usual Care (EUC)
- Family or friend
- People aged 18 years or older
- Is involved with the care of the participant
- The participant has consented to the family member or friend to be involved in the study
- REDUCE Facilitators
- • Eligibility as per the role specification in Section 6.2.2 of study Protocol
Exclusion
- Adults with type 1 diabetes
- Exclusion criteria will include those adults diagnosed less than one year ago. This is because the first 12 months following a diagnosis of T1DM is a period of unique stress due to the diagnosis, the acute onset, and requirement to learn complex new skills. Additionally, due to the honeymoon period, which can typically last up to a year, there is variety in the physiological trajectory which might have an impact that would be difficult to measure and account for in this study(Sokołowska, Chobot et al. 2016).
- Women who are pregnant. This is because the additional burdens and anxieties this population is confronted with may risk confounding the trial findings
- Exclusion of adults with current mental health diagnoses with current symptoms (e.g. psychosis or substance abuse or severe depression), will be evaluated and determined on a case-by-case basis by clinical care teams.
- Health care professionals • People who are unwilling or unable to take on additional workload associated with D-stress e-learning and delivery of Enhanced Usual Care.
- Family or friend
- • Participant with type 1 diabetes has not given consent for a family member or friend to participate in the study
- REDUCE Facilitators
- • Professional accreditation with one of the following professional bodies: Nursing \& Midwifery Council, Health \& Care Professionals Council, British Association for Counselling \& Psychotherapy, and UK Council for Psychotherapy.
- Professional or personal understanding of Type 1 diabetes
- Professional or personal understanding of NHS diabetes care and guidelines
- Professional or personal understanding of diabetes distress
- Professional understanding of mental and emotional health
- Professional experience of in-person and/or online group facilitation especially in managing diverse needs within a group and the expression of strong emotions
- Willingness to be a research participant
Key Trial Info
Start Date :
October 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT07193446
Start Date
October 31 2025
End Date
September 1 2026
Last Update
December 4 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Royal United Hospitals Bath
Bath, United Kingdom
2
University Hospitals Leicester NHS Trust
Leicester, United Kingdom, LE1 7RH,
3
Guy's and St Thomas' Hospitals NHS Trust
London, United Kingdom