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Prevention study for Diabetes Type 1
Official 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)
ClinicalTrials.gov ID: NCT07193446
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- Women who are pregnant. This is because the additional burdens and anxieties this population is confronted with may risk confounding the trial...
- Exclusion of adults with current mental health diagnoses with current symptoms (e.g. psychosis or substance abuse or severe depression), will be...
- 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...
See the full eligibility 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
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bath, United Kingdom
- Leicester, United Kingdom
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bath, United Kingdom; Leicester, United Kingdom; London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.