International – Industry – OVIVA
Title
A Randomised Controlled Trial of Oviva Direkt for Improvement of Glycaemic Control in Patients Living with Type 2 Diabetes Mellitus (T2DM)
Project lead
Mihail Georgiev, Senior Clinical Trial Manager
Contact person, contact details
Mihail Georgiev, mihail.georgiev@oviva.com; +49 151 57724702
Project description / Main objectives; how are the objectives relevant for primary care?
The primary objective is to evaluate the effectiveness of Oviva Direkt Diabetes Typ 2 on glycated haemoglobin (HbA1c) levels after 24 weeks in adults with type 2 diabetes mellitus (T2DM), compared to care as usual.
Secondary objectives are to assess the effects on diabetes self-management and the mental component of quality of life after 24 weeks.
Exploratory objectives include assessing changes in body weight, the physical component of quality of life, lipid profile, and cardiovascular risk after 12 and 24 weeks, as well as HbA1c, self-management, and mental quality of life after 12 weeks.
The study is highly relevant for primary care, as it evaluates a digital therapeutic designed to support structured lifestyle modification and self-management in patients with T2DM, complementing routine care and reducing the burden on healthcare providers.
Study type: e.g. qualitative, quantitative, interventional, observational, epidemiological vs. clinical research, etc.
Prospective, open-label, longitudinal, parallel group, single-blinded, randomised, controlled trial in adults living with T2DM
Participation in the design of the project (for university locations with PBRN) possible until approximately: 01/2026
The project has received Ethics Committee approval, and the first patient in (FPI) has been achieved. To date, eight patients have been enrolled. We are currently amending the study protocol and recruitment strategy, and this is where insights from GP practices would be highly valuable to ensure feasibility and alignment with primary care workflows. At present, GP practices may participate as (1) referral sites and/or (2) blood draw sites. We are also exploring the option to expand their role as full study sites through a substantial amendment, which we plan to submit as soon as possible to enable broader participation of GP practices. GP practices may contribute to this process by providing input on the amendment, joining as referral or blood draw sites, or participating as study investigators.
Participation possible from: 11/2025 to expected: min. 05/2026
The timeline for the study is as follows:
- Site Participation Possible From: November 2025
- Recruitment Period: Ongoing until approximately April–May 2026 or until the target of 240 participants is reached, whichever occurs first.
- Follow-Up Period: Includes onsite visits for follow-up, with the last visit (Last Patient Out – LPO) expected by November 2026.
GP practices can participate at any point during the recruitment and follow-up phases, depending on their capacity and resources. They may join as referral sites, blood draw sites, or full study investigators, with flexibility to contribute based on their availability and resources.
How many practices are needed to participate in the project?
We aim to activate approximately 45 referral GP practices by January 2026, ensuring representation across different regions. The final number of participating practices may vary depending on individual recruitment performance. Our goal is to engage as many practices as possible to achieve the planned total enrolment of 240 participants within the study timelines.
How many patients are needed to participate in the project?
240 in total