Status:
RECRUITING
Evaluating a Digital Intervention for Alleviating Diabetes-specific Emotional Distress in Adults Living With T2DM
Lead Sponsor:
Gaia AG
Collaborating Sponsors:
University Hospital Schleswig-Holstein
Philipps University Marburg
Conditions:
Glucose Metabolism Disorders (Including Diabetes Mellitus)
Metabolic Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This randomized controlled trial (RCT) with 250 patients suffering from type 2 diabetes mellitus (T2DM) aims to investigate the effectiveness of the self-guided digital therapeutic covivio. Inclusion ...
Eligibility Criteria
Inclusion
- male, female or non-binary
- age ≥ 18 years
- diagnosis of T2DM secured via submission of a medical certificate attesting to the presence of at least one of the following ICD-10-GM diagnoses of T2DM: E11.20, E11.30, E11.40, E11.50, E11.60, E11.72, E11.74, E11.80, E11.90
- elevated levels of diabetes-specific emotional distress: cut-off ≥ 33 on the PAID-20
- access to CGM-compatible smartphone
- consent to participate
- sufficient knowledge of the German language
Exclusion
- diagnosis of type 1 diabetes mellitus (T1DM)
- change in medication (type, frequency of use or dosage) within 4 weeks before the baseline visit or planned within the subsequent 6 months
- recent or planned bariatric operation within 4 weeks before the baseline visit or within the subsequent 6 months
- change in psychotherapeutic treatment within 4 weeks before the baseline visit or planned within the subsequent 6 months
- current use of continuous glucose monitoring (CGM) as part of one's diabetes treatment
- experiencing problems with the CGM sensor or insufficient CGM data quality at baseline (T0) (i.e., wearing the CGM sensor on less than 6 of 7 days, providing less than a minimum of 96 hours of glucose values, providing less than 24 hours overnight CGM data)
Key Trial Info
Start Date :
October 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 9 2026
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06529965
Start Date
October 9 2024
End Date
April 9 2026
Last Update
November 8 2024
Active Locations (1)
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1
GAIA AG
Hamburg, Germany, 22085