Clinical trial NCT05525117: Effectiveness of an Online Self-management Intervention for Type 2 Diabetes Mellitus
Official title: Evaluating the Effectiveness of an Online Self-management Intervention for Type 2 Diabetes Mellitus (Covivio): Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Type 2 Diabetes
Keywords: type 2 diabetes
covivio
diabetes self-management
digital health application
Lead sponsor: Gaia AG
Sponsor class: INDUSTRY
First posted: 2022-09-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial with two arms: (i) online intervention in addition to treatment-as-usual versus (ii) treatment-as-usual
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: HbA1c
timeFrame: 6 months
Secondary outcomes:
measure: Depressive symptoms
timeFrame: 6 months
measure: Diabetes Self-management
timeFrame: 6 months
measure: Body Mass Index
timeFrame: 6 months
measure: Health-Related Quality of Life
timeFrame: 6 months
measure: Proportion of patients achieving a reduction in HbA1c
timeFrame: 6 months
Other outcomes:
measure: Waist circumference
timeFrame: 6 months
measure: systolic blood pressure
timeFrame: 6 months
Locations:
city: Hamburg
country: Germany
facility: GAIA
Study officials:
affiliation: Gaia AG
name: Gitta Jacob, PD PhD
role: PRINCIPAL_INVESTIGATOR
References: