Diabetes Type 1NCT07193446
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)
A study testing D-stress study: The detection, prevention and management of diabetes distress for adults living with type 1 diabetes. in people with Diabetes Type 1, run by Guy's and St Thomas' NHS Foundation Trust at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Type 1
- What is being tested?
- D-stress study: The detection, prevention and management of diabetes distress for adults living with type 1 diabetes.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 31 Oct 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom3 sites, 3 recruiting
- Recruiting
Royal United Hospitals Bath
Bath
Sarah Stratton, +441225 826192, sarah.stratton@nhs.net
Kate Hardenberg, +441225 826192, kate.hardenberg@nhs.net
- Recruiting
University Hospitals Leicester NHS Trust
Leicester, LE1 7RH,
Pratik Professor Choudhary, +441162584874, pratik.choudhary@leicester.ac.uk
pratik.choudhary@leicester.ac.uk
- Recruiting
Guy's and St Thomas' Hospitals NHS Trust
London
Sufyan Hussain, +442071881929, sufyan.hussain@kcl.ac.uk
Jiha Jeong, +442071881929, J.Jeong@nhs.net
About this study
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.
- Conditions
- Diabetes Type 1
- Being tested
- D-stress study: The detection, prevention and management of diabetes distress for adults living with type 1 diabetes.
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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. The REDUCE programme aims to prevent and manage elevated diabetes distress.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Usual Care (EUC) | Active comparator | This arm of the study involves health care professionals e-learning training in and delivery of EUC for the detection and management of diabetes distress. Receives: Behavioral: D-stress study: The detection, prevention and management of diabetes distress for adults living with type 1 diabetes. |
| REDUCE Programme Intervention | Experimental | REDUCE intervention is an online group 6 session programme for the management of elevated diabetes distress. Receives: Behavioral: D-stress study: The detection, prevention and management of diabetes distress for adults living with type 1 diabetes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Extent to which of participants find the interventions feasible, and acceptable
- Proportion of people recruited from those eligible/approached
- The number of participants who dropped out
- 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.
Measured: 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.
Measured: 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).
Measured: 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
Assessing whether the initial programme theories underpinning Enhanced Usual Care (control) and REDUCE programme (experimental) explain the outcomes and participant experiences of these interventions. Non-participant observations of control and experimental intervention will be conducted. Realist Process Evaluation interviews with study participants will also be conducted over the course of the study: from day 1 (month 1) through to month 6.
Measured: 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)
The proportion of time interstitial blood glucose is in the range of 4-10 mmol/l (Battelino, Alexander et al. 2022). This will be collected via the participant's continuous glucose monitoring (CGM) device every 30 days (each month) from the start of the study (month 1) through to study completion, an average of 6 months.
In addition to proportion of time interstitial blood glucose is in the range , below range, above range, and glucose variability, measured as coefficient of variation will be measured. Percentage of CGM sensor usage will also be measured. This will allow study investigators to determine the completeness of interstitial blood glucose sensor data and proportion of time in the preceding month the participant's blood glucose was in range.
Measured: 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 Type 1 Diabetes Distress Assessment Scale T1-DDAS 8-item CORE scale will be the key scale used to collect diabetes distress levels. Items are scored between 1 and 5, with one being Not a problem to five being A very serious problem. A core score of under 3 on each item is sub-threshold and ≥3 is elevated. The tool was 'developed and validated and standardized' for adults with Type 1 diabetes by the Behavioural Diabetes Institute to further specify the source of DD as well as the amount of DD (Institute, 2023; Fisher, Polonsky et al. 2024).
Measured: The T1-DDAS measurement scale will be used every 30 days from Month 1 through to study completion, estimated to be 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start31 Oct 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 1Studies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193446
- Sponsor's protocol ID
- 349849
- Other IDs
- PGfAR NIHR205441
- Status last verified
- Nov 2025
- First submitted
- 13 Aug 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07193446
- Acronym / sponsor ID
- 349849
- Conditions
- Diabetes Type 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 31 Oct 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Usual Care (EUC) | Active comparator | Behavioral: D-stress study: The detection, prevention and management of diabetes distress for adults living with type 1 diabetes.This 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 | Experimental | Behavioral: D-stress study: The detection, prevention and management of diabetes distress for adults living with type 1 diabetes.REDUCE intervention is an online group 6 session programme for the management of elevated diabetes distress. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-stress study: The detection, prevention and management of diabetes distress for adults living with type 1 diabetes.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. | Behavioural | Enhanced Usual Care (EUC), REDUCE Programme Intervention |
Primary outcome
Feasibility, service use, acceptability, attrition rate and data quality
Time frame: The study investigators will be collecting data to assess the primary outcome measure at Month 3 and Month 6 of the study.
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.
Diversity of recruited participants against nine protected characteristics
Time frame: This primary outcome data will be collected at month 3 baseline data collection and month 6 follow-up data collection.
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.
To assess the quality of data collected
Time frame: The study investigators will be collecting data to assess the primary outcome measure at monthly throughout the duration of the 6 month study.
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).
3 secondary outcomes
Assessment of initial Realist Process Evaluation programme theories
Time frame: 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)
Time frame: 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)
Time frame: The T1-DDAS measurement scale will be used every 30 days from Month 1 through to study completion, estimated to be 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
University Hospitals Leicester NHS Trust
Leicester, United Kingdom
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D-stress study: The detection, prevention and management of diabetes distress for adults living with type 1 diabetes. in people with Diabetes Type 1, run by Guy's and St Thomas' NHS Foundation Trust at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility, service use, acceptability, attrition rate and data quality (time frame: The study investigators will be collecting data to assess the primary outcome measure at Month 3 and Month 6 of the study.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.