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)

NCT ID: NCT07193446

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2026-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Enhanced Usual Care (EUC)

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.

Group Type ACTIVE_COMPARATOR

D-stress study: The detection, prevention and management of diabetes distress for adults living with type 1 diabetes.

Intervention Type BEHAVIORAL

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.

REDUCE Programme Intervention

REDUCE intervention is an online group 6 session programme for the management of elevated diabetes distress.

Group Type EXPERIMENTAL

D-stress study: The detection, prevention and management of diabetes distress for adults living with type 1 diabetes.

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Royal United Hospitals Bath

Bath, , United Kingdom

Site Status RECRUITING

University Hospitals Leicester NHS Trust

Leicester, , United Kingdom

Site Status RECRUITING

Guy's and St Thomas' Hospitals NHS Trust

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Facility Contacts

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Sarah Stratton

Role: primary

+441225 826192

Kate Hardenberg

Role: backup

+441225 826192

Pratik Professor Choudhary

Role: primary

+441162584874

Role: backup

Sufyan Hussain

Role: primary

+442071881929

Jiha Jeong

Role: backup

+442071881929

Other Identifiers

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PGfAR NIHR205441

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

349849

Identifier Type: -

Identifier Source: org_study_id

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