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)
2 other identifiers
interventional
110
1 country
3
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, burnt-out - is called diabetes distress. It affects people's quality of life and can hinder them from managing their diabetes as well as they can. In the UK, the NHS needs to better understand how to best support people feeling emotionally burdened by diabetes. So, we have worked with diabetes distress specialists around the world to develop an NHS pathway to care for diabetes distress. This pathway to care involves training diabetes teams to recognise, assess and talk about diabetes distress at routine appointments. If people have a high diabetes distress level, they may be able to take part in an online group program to help them manage their type 1 diabetes and emotions. The feasibility study will test this pathway to care with people with type 1 diabetes in the NHS setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2025
Shorter than P25 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2025
CompletedFirst Posted
Study publicly available on registry
September 25, 2025
CompletedStudy Start
First participant enrolled
October 31, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
December 4, 2025
November 1, 2025
8 months
August 13, 2025
November 26, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Feasibility, service use, acceptability, attrition rate and data quality
The main primary outcome measure is to assess the feasibility of the study in relation to progressing to the proposed main trial. As part of the primary outcome the study investigators will be assessing the following: 1. Extent to which of participants find the interventions feasible, and acceptable 2. Proportion of people recruited from those eligible/approached 3. The number of participants who dropped out 4. The quality of the data To conduct these assessments measurements tools used will include: the Acceptability, feasibility and appropriateness of implementation (AIM) (Sturt, Griffiths et al. 2023; Weiner, Lewis 2017), and EQ-5D-5L Quality of Life questionnaire (Feng, Kohlmann et al. 2021). The AIM and EQ-5D-5L measurement tools uses a Likert scale as a unit of measure.
The study investigators will be collecting data to assess the primary outcome measure at Month 3 and Month 6 of the study.
Diversity of recruited participants against nine protected characteristics
The study investigators will be assessing the diversity of recruited participants against against nine protected characteristics with the D-stress study specific measurement tool called, the Health and social equalities.
This primary outcome data will be collected at month 3 baseline data collection and month 6 follow-up data collection.
To assess the quality of data collected
As part of the primary outcome the study investigators will be assessing the quality of data collected via monthly questionnaires using the Acceptability, feasibility and appropriateness of implementation (AIM) (Sturt, Griffiths et al. 2023; Weiner, Lewis 2017), measurement tool realist evaluation process interviews and non-participant observation with study investigators following RAMESES quality and publication standards guidelines (Wong G, Greenhalgh T, Westhorp G, et al. 2013).
The study investigators will be collecting data to assess the primary outcome measure at monthly throughout the duration of the 6 month study.
Secondary Outcomes (3)
Assessment of initial Realist Process Evaluation programme theories
Conducted over the course of the feasibility study from Day 1 through to the completion of the study, an average of 6 months.
Proportion of TIR for interstitial blood glucose (proposed main trial co-primary outcome)
CGM data will be collected monthly from Month 1 through to study completion, an average of 6 months.
Diabetes distress score (proposed main trial co-primary outcome)
The T1-DDAS measurement scale will be used every 30 days from Month 1 through to study completion, estimated to be 6 months.
Study Arms (2)
Enhanced Usual Care (EUC)
ACTIVE COMPARATORThis arm of the study involves health care professionals e-learning training in and delivery of EUC for the detection and management of diabetes distress.
REDUCE Programme Intervention
EXPERIMENTALREDUCE intervention is an online group 6 session programme for the management of elevated diabetes distress.
Interventions
Enhanced Usual Care intervention aims to train health care professionals to detect and prevent, and manage diabetes distress in routine diabetes care, in the UK NHS. The REDUCE programme aims to prevent and manage elevated diabetes distress.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Adults with type 1 diabetes
- Women who are pregnant. This is because the additional burdens and anxieties this population is confronted with may risk confounding the trial findings
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Royal United Hospitals Bath
Bath, United Kingdom
University Hospitals Leicester NHS Trust
Leicester, LE1 7RH,, United Kingdom
Guy's and St Thomas' Hospitals NHS Trust
London, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2025
First Posted
September 25, 2025
Study Start
October 31, 2025
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
December 4, 2025
Record last verified: 2025-11