Type 2 DiabetesOnSeT-2DNCT05525117
Effectiveness of an Online Self-management Intervention for Type 2 Diabetes Mellitus
A study testing covivio (additional to treatment as usual) and treatment as usual in people with Type 2 Diabetes, run by Gaia AG at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- covivio (additional to treatment as usual) and treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- 4 Jul 2023to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- covivio (additional to treatment as usual), treatment as usual
- Keywords
- type 2 diabetes, covivio, diabetes self-management, digital health application
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
covivio (additional to treatment as usual)Behavioural
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.
treatment as usualOther
Participants may continue with any treatment that they require (treatment as usual)
| Study group | Role | What they receive |
|---|---|---|
| online intervention in addition to treatment-as-usual | Experimental | online intervention: covivio in addition to treatment as usual Receives: Behavioral: covivio (additional to treatment as usual) |
| treatment-as-usual | Other | Other: treatment as usual Receives: Other: treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (5)
Depressive symptoms
assessed with the total score of the Patient Health Questionnaire (PHQ-9)
Measured: 6 months
Diabetes Self-management
assessed with the total mean score of the Diabetes Self-management questionnaire (DSMQ)
Measured: 6 months
Body Mass Index
calculated from measurement data of patient's height in meter and weight in kilogram
Measured: 6 months
Health-Related Quality of Life
assessed with the total score of the Assessment of Quality of Life (AQoL-8D)
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start4 Jul 2023
- Primary completion15 Jul 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Why it stopped: No participants could be recruited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial with two arms: (i) online intervention in addition to treatment-as-usual versus (ii) treatment-as-usual
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaia AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gitta Jacob, PD PhD, Principal investigator, Gaia AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525117
- Sponsor's protocol ID
- covivio trial 2022
- Acronym
- OnSeT-2D
- Status last verified
- May 2024
- First submitted
- 30 Aug 2022
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of an Online Self-management Intervention for Type 2 Diabetes Mellitus (Covivio): Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05525117
- Acronym / sponsor ID
- OnSeT-2D / covivio trial 2022
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 diabetes, covivio, diabetes self-management, digital health application
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants could be recruited.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Gaia AGIndustry (pharma, biotech, devices)
- Study start
- 4 Jul 2023 (actual)
- Primary completion
- 15 Jul 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 1 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled trial with two arms: (i) online intervention in addition to treatment-as-usual versus (ii) treatment-as-usual
| Arm | Type | Receives |
|---|---|---|
| online intervention in addition to treatment-as-usual | Experimental | Behavioral: covivio (additional to treatment as usual)online intervention: covivio in addition to treatment as usual |
| treatment-as-usual | Other | Other: treatment as usualOther: treatment as usual |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | online intervention in addition to treatment-as-usual |
| treatment as usualParticipants may continue with any treatment that they require (treatment as usual) | Other | treatment-as-usual |
Primary outcome
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.
5 secondary outcomes
Depressive symptoms
Time frame: 6 months
Diabetes Self-management
Time frame: 6 months
Body Mass Index
Time frame: 6 months
Health-Related Quality of Life
Time frame: 6 months
Proportion of patients achieving a reduction in HbA1c
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gitta Jacob, PD PhD principal investigator
Gaia AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing covivio (additional to treatment as usual) and treatment as usual in people with Type 2 Diabetes, run by Gaia AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.