Status:
UNKNOWN
The SongDanceT1 Study: Stress, Ongoing Self- Monitoring and Diabetes, Nerve Stimulation and Cognitive Empowerment.
Lead Sponsor:
Steno Diabetes Center Copenhagen
Collaborating Sponsors:
Department of Medicine, Endocrine Unit Herlev University Hospital, Herlev, Denmark
Conditions:
Autonomic Dysfunction
Stress, Psychological
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
In an implementation study, designed as a RCT in people with type 1 diabetes(T1D) and an elevated Pressure pain sensitivity of the chest bone(PPS) as indicative of dysfunction of the autonomic nervous...
Detailed Description
Type 1 Diabetes is a chronic disease, affecting mostly young people and associated with depression among approx. 20-25% of the people. Depression in T1D is further associated with a poor treatment ad...
Eligibility Criteria
Inclusion
- Diagnosed T1D
- BMI \< 40
- PPS ≥ 60 arbitrary units (normal range: 30 - 60)
- Age \< 75 years; age ≥ 18 years
- Manage the Danish language for proper use of instructions,
- Actively accepting to conduct a minimum of 20 minutes of self-care daily according to the ULLCARE program.
Exclusion
- Use of Beta blockade medication, and tricyclic anti-depressive medication
- Previously diagnosed and treated for a psychiatric disorder, except for depression.
- A chronic competing disorder that statistically is life-shortening (such as advanced cancer with metastases).
- A chronic competing disorder that is not heart disease and not a diabetes co-morbidity, which clearly impairs the participant's QOL /e.g. COPD, cancer, chronic pain syndrome).
- People who cannot conduct the selfcare program (example: having one arm, only)
Key Trial Info
Start Date :
July 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06087679
Start Date
July 8 2022
End Date
February 1 2024
Last Update
October 30 2023
Active Locations (1)
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1
Steno Diabetes Center Copenhagen
Herlev, Denmark, 2730