Actively Recruiting
Evaluating a Digital Intervention for Alleviating Diabetes-specific Emotional Distress in Adults Living With Type 2 Diabetes Mellitus: Randomized Controlled Trial
Led by Gaia AG · Updated on 2024-11-08
250
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
G
Gaia AG
Lead Sponsor
U
University Hospital Schleswig-Holstein
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the digital therapeutic covivio for adults living with type 2 diabetes mellitus (T2DM) who experience elevated diabetes-specific emotional distress. This randomized controlled trial involves 250 participants and aims to compare covivio plus treatment as usual (TAU) against TAU alone. The study focuses on reducing emotional distress related to diabetes and improving glucose management over six months. Participants will be randomly assigned to either an intervention group receiving access to covivio alongside their usual diabetes care or a control group receiving only usual care. Covivio is a digital health application based on cognitive behavioral therapy principles, accessible through a web browser for 180 days. It offers interactive dialogues, illustrations, audio recordings, motivational messages, and worksheets addressing disease knowledge, physical activity, nutrition, stress, sleep, mood, and social support. During the study, participants will wear continuous glucose monitoring (CGM) devices to assess glucose management and complete questionnaires on emotional distress, self-management skills, quality of life, and body mass index at baseline, 3 months, and 6 months. Researchers will monitor adherence to the digital program and collect data on diabetes distress and glucose control. The study will last at least six months per participant, with the primary outcomes measured at six months.
CONDITIONS
Brief Title
Evaluating a Digital Intervention for Alleviating Diabetes-specific Emotional Distress in Adults Living With T2DM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male, female, or non-binary
- Age 18 years or older
- Confirmed diagnosis of type 2 diabetes mellitus (T2DM) by medical certificate with specified ICD-10-GM codes
- Elevated diabetes-specific emotional distress with a PAID-20 score of 33 or higher
- Access to a smartphone compatible with continuous glucose monitoring (CGM)
- Consent to participate
- Sufficient knowledge of the German language
You will not qualify if you...
- Diagnosis of type 1 diabetes mellitus (T1DM)
- Current use of continuous glucose monitoring (CGM) as part of diabetes treatment
- Changes or planned changes in medication within 4 weeks before baseline or planned within the next 6 months
- Bariatric surgery within 4 weeks before baseline or planned within the next 6 months
- Changes or planned changes in psychotherapeutic treatment within 4 weeks before baseline or planned within the next 6 months
- Problems with CGM sensor use or insufficient CGM data quality at baseline (wearing sensor less than 6 of 7 days or less than 96 hours of glucose data including less than 24 hours overnight)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 180 days
Participants receive access to the digital intervention covivio, which includes interactive dialogues and tools based on cognitive behavioral therapy to help manage diabetes-specific emotional distress. The program is accessible for 180 days. Participants in the control group continue with treatment as usual.
Participants complete questionnaires periodically during the treatment period
Trial Site Locations
Total: 1 location
1
GAIA AG
Hamburg, Germany, 22085
Actively Recruiting
Research Team
G
Gitta A Jacob, PhD
K
Katharina M Rischer, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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