An interventional study of covivio in Glucose Metabolism Disorders (Including Diabetes Mellitus), Metabolic Disease and Endocrine System Diseases, sponsored by Gaia AG. Active, not recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by Gaia AG · Not applicable, Interventional, and Treatment
Among 754 studies in Diabetes Mellitus, Type 2 with a site in Germany — 44 open to participants now, 65 under way, 21 of them phase 3. Diabetes Mellitus, Type 2 · Germany.
Among the 754 studies in Diabetes Mellitus, Type 2 with a site in Germany, this one is the 327th largest by planned enrollment of the 686 interventional ones, is one of 20 that started in 2024, is one of 87 with no phase, reaches primary completion later than 16 of the 64 other live ones, and was the 704th registered.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 250 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →44 of the 754 studies in Diabetes Mellitus, Type 2 with a site in Germany are open now, in 12 countries. Each count lists the studies.
Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 373 (42%) set no upper age limit and 384 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →754 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 20 started in 2024.
Median enrollment 216 across the 686 interventional studies, 1,552 across the 66 observational. Of the 655 that completed or were terminated, 263 (40%) have results posted.
595 of 754 have an industry lead sponsor. The 10 most frequent:
Gaia AG is the lead sponsor of 20 studies on the registry; 2 are open to participants now.
Gaia AG has 2 studies filed under Diabetes Mellitus, Type 2 — fewer than ten, so there is no comparison to draw.
18 of the studies in Diabetes Mellitus, Type 2 with a site in Germany that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06858878Phase 3AmgenEfficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight | 2027-01-21 |
| NCT06993792Phase 3Eli Lilly and CompanyA Master Protocol for Orforglipron (LY3502970) in Participants With Obesity or Overweight With and Without Type 2 Diabetes | 2027-08 |
| NCT06972472Phase 3Eli Lilly and CompanyA Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Type 2 Diabetes | 2027-08 |
| NCT07400653Phase 3PfizerA Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D) | 2027-10-12 |
| NCT03811561Phase 3Novo Nordisk A/SA Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes | 2027-11-07 |
Among the 754 studies in Diabetes Mellitus, Type 2 with a site in Germany, from their registry updates:
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 250 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Gaia AG is the lead sponsor of 20 studies on the registry; 2 are open to participants now.
Compared within Diabetes Mellitus, Type 2, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Glucose Metabolism Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Experimental: covivio + TAU Participants allocated to the intervention group will receive access to covivio in addition to treatment as usual (TAU). covivio is a digital health application designed for individuals with type 2 diabetes mellitus who suffer from elevated levels of diabetes-specific emotional distress, accessible through a web browser. The application focuses on treatment methods derived from cognitive behavioral therapy (CBT). Topics addressed by covivio are disease literacy, physical activity and exercise, nutrition, stress management, sleep management, mood problems, and social resources. The program operates through interactive "dialogues", which are accompanied by illustrations, audio recordings, motivational text messages, worksheets, and summaries. Users are also encouraged to regularly complete short questionnaires to monitor their complaints. Once registered, the program remains accessible for 180 days.
Behavioral: covivio
No Intervention: TAU Participants allocated to the control group will receive access to treatment as usual (TAU).
Participants will receive access to the digital health intervention covivio in addition to TAU.
Diabetes-specific emotional distress
Assessed with the Problem Areas in Diabetes Questionnaire (PAID-20). Total score ranging from 0-100; higher scores indicate higher diabetes-specific emotional distress (worse outcome).
Time frame: 6 months
Glucose management indicator
The glucose management indicator (GMI) is an estimation of HbA1c from CGM. It is calculated as follows: GMI (%) = 3.31 + 0.02392 x \[mean glucose in mg/dL\].
Time frame: 6 months
Diabetes-specific emotional distress
Assessed with the Problem Areas in Diabetes Questionnaire (PAID-20). Total score ranging from 0-100; higher scores indicate higher diabetes-specific emotional distress (worse outcome).
Time frame: 3 months
Diet self-management skills
Assessed with the Diet Subscale of the Summary of Diabetes Self-Care Activities Measure (SDSCA). The diet subscale contains four items and the score may range from 0-28; higher scores indicate higher diet self-management skills (better outcome).
Time frame: 3 months; 6 months
Exercise self-management skills
Assessed with the Exercise Subscale of the Summary of Diabetes Self-Care Activities (SDSCA). The exercise subscale contains two items and the score may range from 0-14; higher scores indicate higher exercise self-management skills (better outcome).
Time frame: 3 months; 6 months
Health-related quality of life
Quantified with the Assessment of Quality of Life - 8 Dimensions (AQoL-8D). Total score ranging from 0-100; higher scores indicate a higher quality of life (better outcome).
Time frame: 3 months; 6 months
Body mass index (BMI)
The BMI will be computed according to the following formula: kg/m2, where kg is a person's weight in kilograms and m2 is their height in meters squared. If necessary, height will be converted into meters and weight will be converted into kilograms.
Time frame: 3 months; 6 months
Time in range (TIR) derived from CGM
Defined as time spent in the target range between 70 and 180 mg/dL. TIR will be assessed in hours and minutes for a 7-day period, and also expressed as percent.
Time frame: 6 months
Mean sensor glucose derived from CGM
Mean sensor glucose will be calculated over the 7 days of glucose measurements.
Time frame: 6 months
Coefficient of variation derived from CGM
The coefficient of variation will be used to quantify glycemic variability.
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2024 (actual). Primary completion is estimated for Dec 2026, 26 months after the start.
Of 177 industry-sponsored interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 29. This study's planned 26 months is above that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Gaia AG