Evaluating a Digital Intervention for Alleviating Diabetes-specific Emotional Distress in Adults Living With T2DM

Launched by GAIA AG · Jul 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a digital program called covivio, designed to help adults with type 2 diabetes manage emotional distress related to their condition. The trial will involve 250 participants who have been diagnosed with type 2 diabetes and are experiencing significant emotional distress. To be eligible, individuals must be at least 18 years old, speak German well, and have a confirmed diagnosis of type 2 diabetes. They should also have high levels of emotional distress, as measured by a specific questionnaire. However, those with type 1 diabetes, recent changes in medications, or certain planned surgeries will not be able to participate.

Participants in the trial will be randomly divided into two groups. One group will use the covivio program along with their usual diabetes care, while the other group will only receive their usual care. Over six months, researchers will look at how well the covivio program helps reduce emotional distress and improve blood sugar control, as well as other aspects like diabetes management skills and quality of life. This trial is currently recruiting participants, and it offers a chance for individuals struggling with the emotional side of diabetes to try a new digital support tool.

Gender

ALL

Eligibility 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)