Effectiveness of an Online Self-management Intervention for Type 2 Diabetes Mellitus
Reason given: No participants could be recruited.
Key facts
- Where
- Hamburg, GermanySee the site
Where in Germany
- GAIAHamburg, GermanyNo longer taking part
Trial details
- Who runs it
- Gaia AG
- Trial code
- NCT05525117
- Record updated
- 28 May 2024
- Original description
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.Read full original descriptionShow less
Evaluating the Effectiveness of an Online Self-management Intervention for Type 2 Diabetes Mellitus (Covivio): Randomized Controlled Trial
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.
Inclusion: 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: change in medication, frequency of use or dosage (planned within 4 weeks before T0 or during the study period); diagnosis of type 1 diabetes mellitus (T1DM).