Effectiveness of an Online Self-management Intervention for Type 2 Diabetes Mellitus

Type 2 Diabetes Clinical Trial

— OnSeT-2D  

Official title:

Evaluating the Effectiveness of an Online Self-management Intervention for Type 2 Diabetes Mellitus (Covivio): Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05525117
• Other study ID #: covivio trial 2022
• Status: Withdrawn
• Phase: N/A
• Start date: July 4, 2023
• Est. completion date: December 15, 2024

Study information

• Verified date: May 2024
• Source: Gaia AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 15, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• covivio (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.

Other:
• treatment as usual
Participants may continue with any treatment that they require (treatment as usual)

Locations

Country	Name	City	State
Germany	GAIA	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Gaia AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Waist circumference	measured at the midpoint between the lower rib and iliac crest in centimeters	6 months
Other	systolic blood pressure	measured with a calibrated sphygmomanometer while the subject is sitting	6 months
Primary	HbA1c	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.	6 months
Secondary	Depressive symptoms	assessed with the total score of the Patient Health Questionnaire (PHQ-9)	6 months
Secondary	Diabetes Self-management	assessed with the total mean score of the Diabetes Self-management questionnaire (DSMQ)	6 months
Secondary	Body Mass Index	calculated from measurement data of patient's height in meter and weight in kilogram	6 months
Secondary	Health-Related Quality of Life	assessed with the total score of the Assessment of Quality of Life (AQoL-8D)	6 months
Secondary	Proportion of patients achieving a reduction in HbA1c	A reduction of HbA1c values by at least 0.3% from baseline to T2 will be considered a significant clinical improvement in glycemic control	6 months