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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)

Sponsor: Guy's and St Thomas' NHS Foundation Trust

NCT ID: NCT07193446

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
D-stress study: The detection, prevention and management of diabetes distress for adults living with type 1 diabetes. (behavioural)
How long the study runs
Study runs about 11 months (dates as stated)
About the drug or intervention
D-stress study: The detection, prevention and management of diabetes distress for adults living with type 1 diabetes. — behavioural: 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.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
110
Started
2025-10-31
Last checked
2025-11

Plain English Summary

What is this study?

  • • Testing a new treatment for diabetes type 1
  • • NA - 110 participants
  • • Up to one in two adults with type 1 diabetes find living with and managing diabetes to be emotionally challenging

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with diabetes type 1

Where?

  • • Bath - Royal United Hospitals Bath
  • • Leicester - University Hospitals Leicester NHS Trust
  • • London - Guy's and St Thomas' Hospitals NHS Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Diabetes Type 1

How this trial compares with your answers

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What we know so far

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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓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

Who cannot take part

  • ✗Adults with type 1 diabetes
  • ✗Women who are pregnant. This is because the additional burdens and anxieties this population is confronted with may...
  • ✗Health care professionals • People who are unwilling or unable to take on additional workload associated with...
  • ✗Family or friend
  • ✗Participant with type 1 diabetes has not given consent for a family member or friend to participate in the study
See the full 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 Is This Study? (3 UK sites)

Royal United Hospitals Bath

Bath, United Kingdom

Recruiting
Site contact (verified)
Kate HardenbergPrincipal Investigator

University Hospitals Leicester NHS Trust

Leicester LE1 7RH,, United Kingdom

Recruiting
Site contact (verified)
Pratik ChoudharyPrincipal Investigator

Guy's and St Thomas' Hospitals NHS Trust

London, United Kingdom

Recruiting
Site contact (verified)
Data sourced from ClinicalTrials.gov · Last verified: 2025-11