Optimising the delivery of Diabetes Distress informed care for its prevention, detection, and management in adults with type 1 diabetes: a hybrid effectiveness – implementation programme (D-Stress study)

Background Almost half of adults with type 1 diabetes experience elevated diabetes distress. Diabetes distress is experienced when a person feels burdened or overwhelmed by living with diabetes.

It contributes to poor diabetes outcomes such as hypoglycaemia and hyperglycaemia because it compromises the person s ability to execute self-care behaviours necessary for good health.

Hypo and hyperglycaemia contribute to high health care costs due to hospital stays and eye, nerve, kidney and vascular disease. No effective treatments are available in the UK.

Researchers in the USA, Denmark and Australia have developed and evaluated interventions for detecting, managing, and preventing diabetes distress. Although these are proving effective, they are not used in the UK. These international treatments will combine to form the D-Stress care pathway.

We will evaluate D-Stress to see if it reduces diabetes distress and improves interstitial glucose in people with type 1 diabetes.

Alongside we will determine for whom D-stress works and in what context and understand how to implement D-Stress widely following the research.

Research questions How can type 1 diabetes care be optimised for the prevention, detection, and management of diabetes distress in adults with type 1 diabetes?

Design and method Using a Hybrid 2 effectiveness-implementation design we deliver cost effectiveness evidence of D-stress in a stepped-wedge cluster randomised trial and develop evidence for optimising implementation using a realist process evaluation.

Project 1 Co-adaption of existing international diabetes distress interventions into the D-Stress care pathway and co-production of an initial D-Stress programme theory. PPIE and stakeholder workshops and literature reviewing are supported by an Expert Reference Group.

Project 2 Feasibility trial and realist evaluation to determine trial and D-stress feasibility and evaluation of the initial programme theory.

Four diabetes clinics, from geographically diverse regions, with eighty adults with type 1 diabetes using continuous glucose monitoring, will participate. Twenty participants and ten healthcare professionals will be interviewed. Data will confirm whether the trial is feasible, and the programme theory will be confirmed.

Project 3 Evaluates the effects and cost-effectiveness of REDUCE, a single D-stress component, on elevated diabetes distress and interstitial glucose time in range. Twenty diabetes services across England and Wales will each recruit 40 participants (N=800) to the trial. Clusters are randomised to receive REDUCE to 10 intervention sequences over 12 months.

Project 4 uses realist process evaluation methods and implementation science to understand for whom D-Stress, as a whole pathway, works, how, why and under what circumstances and to optimise the implementation solutions for upscaling . Participants and stakeholders will provide qualitative and survey data.

The programme theory for preventing, detecting and managing diabetes distress will be evaluated.

Dissemination and Impact An ambitious dissemination and impact strategy for delivery during the grant life will be planned at the project commencement with the PPIE and the Programme Steering Group. This may include timely roll out of diabetes distress e-learning and consultation resources across the NHS in year 2.

We will publish, present, have a website and a social media strategy as findings and impacts are delivered.