Evaluating a Digital Intervention for Alleviating Diabetes-specific Emotional Distress in Adults … (NCT06529965) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluating a Digital Intervention for Alleviating Diabetes-specific Emotional Distress in Adults Living With T2DM
Germany250 participantsStarted 2024-10-09
Plain-language 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 criteria are: male, female or non-binary; age ≥ 18 years; confirmed diagnosis of T2DM; elevated levels of diabetes-specific emotional distress (Problem Areas in Diabetes \[PAID\]-20 score ≥ 33); consent to participate; sufficient German language skills. Exclusion criteria are: a diagnosis of type 1 diabetes mellitus (T1DM); current use of continuous glucose monitoring (CGM) as part of one's diabetes treatment; changes or planned changes in medication within 4 weeks before the baseline visit or in the subsequent 6 months; a bariatric operation within 4 weeks before the baseline visit or such an operation planned in the subsequent 6 months; changes or planned changes in psychotherapeutic treatment within 4 weeks before the baseline visit or in the subsequent 6 months. In addition, participants will be excluded from the study if they did not wear the CGM sensor for at least 6 of 7 days at baseline (before randomization), providing a minimum of 96 hours of glucose values including at least 24 hours overnight.
Patients will be randomized and allocated in a 1:1 ratio to either an intervention group, in which they will receive access to covivio in addition to treatment as usual (TAU, n = 125), or to a control group, in which they will receive only TAU (n = 125).
Co-primary endpoints of this trial will be the between-groups difference in the PAID-20 total score in the intervention and control group at six months, adjusted for the PAID-20 baseline score as well as the glucose management indicator (estimated HbA1c) assessed using continuous glucose monitoring devices (for a period of 7 days) at six months, adjusted for the baseline score.
Secondary endpoints will be diabetes self-management skills, body mass index (BMI), and quality of life.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a digital program aimed at reducing the emotional distress that comes with managing Type 2 diabetes — is that something you think would address a real gap in my current care?
2Since this trial is 'active but not recruiting,' the enrollment window has closed — are there similar digital or psychological support programs I could still access today, either through a study or as standard care?
3The trial is measuring both emotional distress and a glucose management indicator — does that mean the researchers believe reducing diabetes-related stress could actually improve my blood sugar control, and is that something worth pursuing in my situation?
4This is listed as Phase NA, which often applies to behavioral or non-drug studies — does that mean the main unknowns here are about how well the program works rather than whether it's physically safe?
5Given that this particular trial is no longer enrolling, would you recommend I focus on standard diabetes distress support options, or do you know of other active studies looking at the mental and emotional side of living with Type 2 diabetes?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.