Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07193446

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)

Led by Guy's and St Thomas' NHS Foundation Trust · Updated on 2025-12-04

110

Participants Needed

3

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying adults with type 1 diabetes to better understand and improve support for those experiencing diabetes distress, which includes feelings like worry, frustration, and sadness related to managing diabetes. The study aims to test an NHS care pathway designed to help identify and manage this emotional burden. This pathway involves training diabetes care teams to recognize and discuss diabetes distress during routine visits. The research is a feasibility study conducted in the NHS setting to see how well this approach works for patients and care teams. The study includes two main groups: one where health care professionals receive e-learning training to provide Enhanced Usual Care (EUC) focused on detecting and managing diabetes distress, and another where participants with elevated distress join a six-session online group program called REDUCE. The REDUCE program is designed to help participants manage both their emotions and diabetes more effectively. These interventions aim to see how feasible and acceptable this care pathway is within routine NHS diabetes services. Participants will be followed for about six months, during which data will be collected monthly on feasibility, service use, participant diversity, and data quality. Researchers will also measure blood glucose control using continuous glucose monitoring and assess diabetes distress levels with a specific scale every 30 days. Additional evaluations include a process review of the program theories over the study duration. This comprehensive data collection will help determine how well the care pathway works and its potential for wider use.

CONDITIONS

Brief 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)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults with type 1 diabetes
  • Age 18 years or older
  • Diagnosed with type 1 diabetes for more than one year
  • Used a Continuous Glucose Monitoring device for at least 3 months before the study
  • Health care professionals who are members of a multidisciplinary diabetes team and willing to undertake Enhanced Usual Care training
  • Family or friends aged 18 or older involved in the care of a participant who has consented to their involvement
  • REDUCE facilitators meeting role specifications in the study protocol
Not Eligible

You will not qualify if you...

  • Adults diagnosed with type 1 diabetes less than one year ago
  • Pregnant women
  • Adults with current mental health diagnoses with active symptoms, such as psychosis, substance abuse, or severe depression, as determined by clinical care teams
  • Health care professionals unwilling or unable to take on the additional workload of training and delivering Enhanced Usual Care
  • Family or friends not consented by the participant to participate
  • REDUCE facilitators not meeting professional accreditation or role requirements as specified in the study protocol

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - Approximately 6 months

Participants receive behavioral interventions including Enhanced Usual Care training or the REDUCE online group program to manage diabetes distress.

Monthly visits for assessments throughout the 6 months

Trial Site Locations

Total: 3 locations

1

Royal United Hospitals Bath

Bath, United Kingdom

Actively Recruiting

2

University Hospitals Leicester NHS Trust

Leicester, United Kingdom, LE1 7RH,

Actively Recruiting

3

Guy's and St Thomas' Hospitals NHS Trust

London, United Kingdom

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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