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)

Overview

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.

Interventions

• Behavioral 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.

Primary outcome measures

• 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.]
• 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.]
• 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.]

Secondary outcome measures (3)

• 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.]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Treatment

Study locations

United Kingdom · 3 centers

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

Identifiers

NCT: NCT07193446 · 349849 · PGfAR NIHR205441

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗