Digital intervention to reduce emotional distress in adults with type 2 diabetes
Evaluating a Digital Intervention for Alleviating Diabetes-specific Emotional Distress in Adults Living With Type 2 Diabetes Mellitus: Randomized Controlled Trial
This study is testing a new digital program to see if it can help adults with type 2 diabetes feel less emotional distress and better manage their condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gaia AG Industry-sponsored |
| Locations | 1 site (Hamburg) |
| Trial ID | NCT06529965 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial involves 250 adults diagnosed with type 2 diabetes mellitus (T2DM) to evaluate the effectiveness of a self-guided digital therapeutic called covivio. Participants will be selected based on their elevated levels of diabetes-specific emotional distress, as measured by the PAID-20 score. The study aims to provide insights into how digital health applications can assist in diabetes self-management and improve emotional well-being. Eligible participants must be at least 18 years old, have sufficient German language skills, and own a CGM-compatible smartphone.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of type 2 diabetes and elevated emotional distress levels.
Not a fit: Patients with type 1 diabetes or those currently using continuous glucose monitoring may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce emotional distress in patients with type 2 diabetes, leading to improved overall health and diabetes management.
How similar studies have performed: Previous studies have shown promise in using digital interventions for diabetes management, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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)
Where this trial is running
Hamburg
- Gaia Ag — Hamburg, Germany (Recruiting)
Study contacts
- Principal investigator: Kamila Jauch-Chara, Dr. med. — Zentrum für Integrative Psychiatrie, Universitätsklinikum Schleswig-Holstein
- Study coordinator: Gitta A Jacob, PhD
- Email: gitta.jacob@gaia-group.com
- Phone: +49 40 349930-374
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.