Improving care for diabetes-related emotional distress in adults with type 1 diabetes
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)
NA · Guy's and St Thomas' NHS Foundation Trust · NCT07193446
This project will test a care pathway that trains NHS diabetes teams to spot and talk about diabetes-related emotional distress and offer an online group program for adults with type 1 diabetes who use continuous glucose monitoring.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Guy's and St Thomas' NHS Foundation Trust (other) |
| Locations | 3 sites (Bath and 2 other locations) |
| Trial ID | NCT07193446 on ClinicalTrials.gov |
What this trial studies
This feasibility study will implement a care pathway in NHS diabetes services that trains multidisciplinary teams to recognise and discuss diabetes distress during routine appointments. Participating clinics will screen adults with type 1 diabetes (diagnosed more than one year and using a continuous glucose monitor for at least three months) and offer referral to an online group program for those with high distress. Healthcare professionals will receive Enhanced Usual Care training and family or friends may be involved if the participant consents. The study will measure feasibility outcomes such as training uptake, screening and referral rates, acceptability, and delivery of the pathway across sites in Bath, Leicester, and London.
Who should consider this trial
Good fit: Adults aged 18 or older with type 1 diabetes for more than one year who have been using a continuous glucose monitoring device for at least three months are the ideal candidates.
Not a fit: People diagnosed with type 1 diabetes less than one year ago, those not using continuous glucose monitoring, or those unwilling/unable to take part in online group programs are unlikely to benefit from this specific pathway.
Why it matters
Potential benefit: If successful, the pathway could help people feel less overwhelmed, improve quality of life, and support better diabetes self-management by identifying and treating distress earlier.
How similar studies have performed: Related psychosocial screening and group-support interventions have shown benefits in reducing diabetes distress, but embedding a whole-pathway approach within routine NHS care at scale is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Criteria: 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
Where this trial is running
Bath and 2 other locations
- Royal United Hospitals Bath — Bath, United Kingdom (RECRUITING)
- University Hospitals Leicester NHS Trust — Leicester, United Kingdom (RECRUITING)
- Guy's and St Thomas' Hospitals NHS Trust — London, United Kingdom (RECRUITING)
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.
Conditions: Diabetes Type 1