Type 2 Diabetes
Conditions
Keywords
type 2 diabetes, covivio, diabetes self-management, digital health application
Brief summary
This trial was designed to evaluate the effectiveness of the dialogue-based online intervention covivio, which was designed to improve diabetes self-management in patients with type 2 diabetes. The study aims to test the hypothesis that covivio has a greater positive impact on glycemic control than treatment as usual. Patients with type 2 diabetes mellitus will be randomized and allocated to either an intervention group, receiving covivio in addition to treatment as usual, or a control group, which receives only treatment as usual. The primary endpoint is the HbA1c value six month after baseline.
Detailed description
The aim of this clinical trial is to investigate the effectiveness of the self-guided digital therapeutic covivio in 268 patients with type 2 diabetes mellitus (T2DM). 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 = 134), or to a control group, in which they will receive only TAU (n = 134). The primary endpoint of this trial will be the between-groups difference of the HbA1c in the intervention and control group at six months adjusted for the baseline HbA1c. In order to show the course of change over time, two timepoints for assessment of effects are planned at four (T1) and six months (T2) after the baseline assessment (T0). The primary endpoint will be the HbA1c at six months post-allocation. Secondary endpoints will be depression, diabetes self-management (DSM), BMI, and quality of life. Figure 1 (section 6.1) summarizes the design of the clinical trial.
Interventions
BEHAVIORALcovivio (additional to treatment as usual)
Covivio is a dialogue-based online psychological intervention for patients with type 2 diabetes. This intervention includes elements that address disease literacy, physical activity and exercise, dieting and nutritional principles, coping with depression, etc. Content is adapted to users needs using interactive dialogues, illustrations and audio files. Participants may also continue with their usual treatment.
OTHERtreatment as usual
Participants may continue with any treatment that they require (treatment as usual)
Sponsors
Gaia AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
randomized controlled trial with two arms: (i) online intervention in addition to treatment-as-usual versus (ii) treatment-as-usual
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* diagnosis of T2DM (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) * HbA1c value ≥ 7.0% (53 mmol/mol) * BMI ≥ 23 kg/m2 * Consent to participate * Sufficient knowledge of the German language
Exclusion criteria
* diagnosis of type 1 diabetes mellitus (T1DM) * change in medication, frequency of use or dosage (planned within 4 weeks before T0 or during the study period)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 6 months | The primary objective of this study is to determine whether the online intervention covivio will reduce HbA1c values in the intervention group compared to the control group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depressive symptoms | 6 months | assessed with the total score of the Patient Health Questionnaire (PHQ-9) |
| Diabetes Self-management | 6 months | assessed with the total mean score of the Diabetes Self-management questionnaire (DSMQ) |
| Body Mass Index | 6 months | calculated from measurement data of patient's height in meter and weight in kilogram |
| Health-Related Quality of Life | 6 months | assessed with the total score of the Assessment of Quality of Life (AQoL-8D) |
| Proportion of patients achieving a reduction in HbA1c | 6 months | A reduction of HbA1c values by at least 0.3% from baseline to T2 will be considered a significant clinical improvement in glycemic control |
Other
| Measure | Time frame | Description |
|---|---|---|
| Waist circumference | 6 months | measured at the midpoint between the lower rib and iliac crest in centimeters |
| systolic blood pressure | 6 months | measured with a calibrated sphygmomanometer while the subject is sitting |
Countries
Germany
Outcome results
None listed