Optimising the prevention, detection and management of diabetes distress in adults with type 1 diabetes: Feasibility study protocol (D-stress feasibility study)

Introduction

Diabetes distress describes the psychological and emotional burden of living with diabetes and is associated with reduced self-management and adverse diabetes outcomes. Clinical guidelines recommend routine assessment and management of diabetes distress, but this is not always implemented. Therefore, there is a need to develop approaches to deliver emotional health support in routine clinical care more effectively.

We describe here the protocol for a study to I) assess the feasibility of implementation of the D-stress Pathway, comprising Enhanced Usual Care (EUC) and an online, group-based, psychological diabetes distress reduction intervention called REDUCE, ii) evaluate the feasibility of the study protocol iii) detect an effect signal of diabetes distress score and Interstitial Glucose Time in Range and iv) refine initial programme theories of how both interventions (EUC and REDUCE) work, for whom, and under what circumstances.

Methods

This feasibility study includes a multicentre trial within a cohort design (TWICs) where sites have a staggered exposure to the interventions alongside a realist process evaluation. Four UK NHS diabetes services will recruit 80 adults with type 1 diabetes (≥1 year) using continuous glucose monitoring (CGM) (≥3 months). All participants will receive EUC and provide monthly data over 7 months on diabetes distress (measured by the Type 1 Diabetes Distress Assessment System (T1DDAS) and interstitial glucose measured by using continuous glucose monitoring. Participants with elevated diabetes distress, will be offered the six-week, group-based, online REDUCE intervention plus EUC, compared to EUC alone. Up to twenty participants with type 1 diabetes, ten family members/friends, sixteen healthcare professionals delivering EUC and five REDUCE facilitators will be interviewed to explore their experience of receiving training and delivering the D-stress Pathway. Up to 20 EUC consultations and REDUCE sessions will be observed.

Analysis

Feasibility will be assessed against pre-specified progression criteria and analysed descriptively using summary statistics. Primary outcomes include baseline level of diabetes distress, recruitment rate, intervention uptake, and data completeness, which will be analysed descriptively. Qualitative data will be analysed using framework analysis guided by realist programme theories developed for this study.

Ethics

Ethics approval has been granted by NHS Research Ethics Committee (REC) (Bromley REC: 25/LO/0469) and Health Research Authority obtained. All participants will provide informed consent.

Trial registration no

Registered at ClinicalTrials.gov number NCT07193446 on 26/11/2025.

Protocol and statistical analysis plan

The trial protocol and statistical analysis plan can be accessed at ClinicalTrials.gov .

Strengths and Limitations

• Evaluates the delivery of an evidence-based care pathway for diabetes distress.

• Addresses recommendations from clinical guidelines.

• The study uses mixed methods approach to assess feasibility outcomes.

• Findings may have limited generalisability beyond the study settings and populations included.

• Estimates of the intervention impact may be limited.

What is already known on this topic – summarise the state of scientific knowledge on this subject before you did your study and why this study needed to be done

International clinical guidelines for the assessment and management of diabetes distress recommend comprehensive assessment with discussion as part of routine care with psychological interventions for managing elevated diabetes distress.

What this study adds – summarise what we now know as a result of this study that we did not know before

The study will assess the feasibility of delivering a care pathway for diabetes distress and its impact on emotional, behavioural and clinical health outcomes and identify the contexts and circumstances that support care pathway delivery and impact for people with type 1 diabetes. It will inform subsequent main study planning by ascertaining feasibility of recruitment, intervention delivery and determining recruitment and attrition rates.

How this study might affect research, practice or policy – summarise the implications of this study

The study will deliver an evidence-based care pathway, and a research protocol, for a subsequent main study evaluation. The main study will provide evidence for the care pathway which aligns with the 2026 EASD Clinical Guideline for the assessment and management of diabetes distress in routine care.