Effectiveness of an Online Self-management Intervention for Type 2 Diabetes Mellitus (OnSeT-2D)

February 15, 2024 updated by: Gaia AG

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

268

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Hamburg, Germany, 22085
        • Recruiting
        • GAIA
        • Contact:
          • Gitta Jacob, PD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: online intervention in addition to treatment-as-usual
online intervention: covivio in addition to treatment as usual
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
Other: treatment as usual
Other: treatment as usual
Participants may continue with any treatment that they require (treatment as usual)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive symptoms
Time Frame: 6 months
assessed with the total score of the Patient Health Questionnaire (PHQ-9)
6 months
Diabetes Self-management
Time Frame: 6 months
assessed with the total mean score of the Diabetes Self-management questionnaire (DSMQ)
6 months
Body Mass Index
Time Frame: 6 months
calculated from measurement data of patient's height in meter and weight in kilogram
6 months
Health-Related Quality of Life
Time Frame: 6 months
assessed with the total score of the Assessment of Quality of Life (AQoL-8D)
6 months
Proportion of patients achieving a reduction in HbA1c
Time Frame: 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
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Waist circumference
Time Frame: 6 months
measured at the midpoint between the lower rib and iliac crest in centimeters
6 months
systolic blood pressure
Time Frame: 6 months
measured with a calibrated sphygmomanometer while the subject is sitting
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gaia AG

Investigators

  • Principal Investigator: Gitta Jacob, PD PhD, GAIA AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2023

Primary Completion (Estimated)

July 15, 2024

Study Completion (Estimated)

December 15, 2024

Study Registration Dates

First Submitted

August 30, 2022

First Submitted That Met QC Criteria

August 30, 2022

First Posted (Actual)

September 1, 2022

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • covivio trial 2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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