Improving care for diabetes-related emotional distress in adults with type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This feasibility study will implement a care pathway in NHS diabetes services that trains multidisciplinary teams to recognise and discuss diabetes distress during routine appointments. Participating clinics will screen adults with type 1 diabetes (diagnosed more than one year and using a continuous glucose monitor for at least three months) and offer referral to an online group program for those with high distress. Healthcare professionals will receive Enhanced Usual Care training and family or friends may be involved if the participant consents. The study will measure feasibility outcomes such as training uptake, screening and referral rates, acceptability, and delivery of the pathway across sites in Bath, Leicester, and London.

Why it matters

Who can join: the full rules

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

Where it's running

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Remote-patient monitoring in diabetes care shows real-world outcomes

  A real-world, pre-post observational study at Steno Diabetes Center Copenhagen tests whether adding remote-patient-monitoring within the EHR can maintain glycemic outcomes over two years for about 12,000 people with diabetes compared with prior ambulatory care.

  Recruiting Steno Diabetes Center Copenhagen · Herlev · NCT07617519

• Brain insulin resistance and brain health in people with diabetes

  This project will test whether brains that don't respond well to insulin in people aged 50–80 with type 1 or type 2 diabetes are linked to worse thinking and structural brain changes compared with people without diabetes.

  Recruiting at 3 sites Copenhagen University Hospital, Rigshospitalet · Glostrup Municipality and 2 other locations · NCT07374705

• Person-centred nutritional education to promote a healthy Nordic diet for adults with Type 1 diabetes

  This project tests whether person-centred nutrition education that supports a healthy Nordic diet can improve blood sugar time-in-range in adults with Type 1 diabetes compared with brief dietary information.

  Recruiting Umeå University · Enköping, Uppland · NCT07258758

• Using the mylife CamAPS FX with the Dexcom G6 for people with type 1 diabetes in France

  This project will see if using the mylife CamAPS FX hybrid closed-loop system paired with the Dexcom G6 sensor improves blood sugar control over one year in people with type 1 diabetes in France.

  Recruiting at 22 sites mylife Diabetes Care AG · Amiens and 21 other locations · NCT07048795

• Evaluating contactless devices for measuring skin microcirculation in type 1 diabetes

  This study is testing two new contactless devices to see how well they can measure blood flow in the skin of people with type 1 diabetes.

  Recruiting HJN Sverige AB/Neko Health · Stockholm · NCT06989190

• Evaluating the effects of Semaglutide and Empagliflozin with Automated Insulin Delivery on diabetes control in adults with Type 1 Diabetes

  This study is testing if adding two diabetes medications, Semaglutide and Empagliflozin, to automated insulin delivery systems can help adults with Type 1 Diabetes better manage their blood sugar levels.

  Recruiting Phase 3 McGill University Health Centre/Research Institute of the McGill University Health Centre · Montreal, Quebec · NCT06894784

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.