Check eligibility
Supporting your Type 2 Diabetes management: Join a digital health study
We're enrolling 240 adults with Type 2 Diabetes in Germany. We invite you to take part in this study testing a smartphone app designed to support dietary and lifestyle changes. Participants receive up to [$X TOTAL AMOUNT] plus equipment and travel reimbursement.
Study overview
Your Participation
This study consists of using a diabetes management app (if assigned to intervention group) or continuing usual care only for 24 weeks, 3 clinic visits for blood tests, online surveys, and at-home blood pressure and weight measurements.
Compensation
Participants receive up to [$X TOTAL AMOUNT] for completing all study activities, plus reimbursement for travel and meal expenses. You'll also keep the weighing scales and blood pressure monitor provided.
Timeline
Currently enrolling 240 participants across Germany. Screening includes an online questionnaire, document upload, and video consent call. Once enrolled, study participation is 24 weeks with follow-up assessments at Weeks 6, 12, 18, and 24.
Study Location
Available to participants across Germany with clinic visits in [list cities]. You'll attend your nearest clinic location for 3 blood tests during the study.
Next Steps
Step 1: Pre-screening
Complete an online questionnaire about your diabetes, health status, and lifestyle ([X-X] min). Have information about your Type 2 Diabetes diagnosis and current medications ready.
Step 2: Upload medical documents
Sign a short-form consent to share medical information. You will be provided with a letter for your GP to sign to confirm your potential eligibility. You can also give the study team permission to contact your GP on your behalf to obtain this information.
Step 3: Video informed consent and screening call
Join a video call with a trial investigator ([X-X] min) to learn about the study, ask questions, and electronically sign the full consent form if you'd like to participate. The investigator will confirm your eligibility.
Step 4: Clinic visit and equipment delivery
Visit your nearest clinic for a blood test ([X-X] min) to confirm eligibility. Receive home equipment (scales and blood pressure monitor) and complete baseline measurements at home.
Step 5: Begin 24-week study period
You'll be randomly assigned to the intervention group (app + usual care) or control group (usual care only). Complete assessments at Weeks 6, 12, 18, and 24 with clinic blood tests at Weeks 12 and 24.
Patient Stories
Who is this study for?
You may be eligible if you meet the following requirements:
Gender:
All genders
Age:
18 years and above
Diabetes Type:
Type 2 Diabetes
Have been diagnosed with Type 2 Diabetes Mellitus
Are 18 years of age or older
Can attend clinic visits in Berlin, Offenbach am Main, Schenefeld, or Munich
Have access to a smartphone for potential app use
Are not currently using another digital lifestyle intervention for diabetes or obesity
Currently use another digital lifestyle intervention to treat diabetes or obesity
Are unable to attend clinic visits at the designated locations
Do not have a confirmed Type 2 Diabetes diagnosis
Cannot complete online surveys or at-home measurements
Are unable to provide a completed GP letter about your recent HbA1c results or do not give the study team permission to obtain this on your behalf
Your questions answered
What is this study about?
Type 2 Diabetes affects millions of people, and managing blood glucose levels is essential for long-term health. We're testing whether the Oviva Direkt Diabetes Typ 2 app - which helps you track meals, weight, blood glucose, and blood pressure and can improve blood glucose control when used alongside your usual care. You'll be randomly assigned (equal chance) to either use the app with your usual care or continue with your usual care only for 24 weeks. If you're in the usual care group, you'll receive free access to the app after the study ends.
Who is Oviva AG?
Oviva AG is a provider of digitally-enabled care for people living with weight-related conditions such as obesity and Type 2 Diabetes. They developed the Oviva Direkt Diabetes Typ 2 programme being tested in this study. Oviva is the sponsor funding this research.
Who is Lindus Health?
Lindus Health is the contract research organization managing this study and acting as the virtual trial site. We handle participant enrollment, virtual and in-person visits, data collection, and ensure the study follows all regulatory requirements. Prof. Dr. Dirk Müller-Wieland is the Principal Investigator for this trial.
What happens after I complete the online questionnaire?
Our team will review your responses within [X-X] business days. If you appear to meet initial eligibility criteria, we'll contact you with instructions to obtain a signed letter from your GP and upload this, or the study team will do this on your behalf if you provide permission. After reviewing your documents, if you remain eligible, we'll invite you to schedule a video call with a trial investigator to discuss the study in detail and complete the consent process.
Can I withdraw from the study at any time?
Yes, you can withdraw at any time without giving a reason and without affecting your medical care. Data collected up to the point of withdrawal may still be used if needed to achieve study objectives or protect participant interests. You'll be compensated for any study activities you completed before withdrawing.
Why should I participate?
You'll contribute to research that could improve diabetes management for many people. You'll receive detailed monitoring of your diabetes including blood tests for HbA1c, kidney function, and cholesterol. If assigned to the intervention group, you'll access personalized dietary and lifestyle support through the app. You'll be compensated for your time and travel, and you'll keep the weighing scales and blood pressure monitor provided.
What are the risks?
Blood tests may cause temporary discomfort, including a pinching sensation, soreness, bruising at the needle site, or rarely, dizziness, upset stomach, infection, or nerve injury. There are no known risks associated with the digital app itself.
How will I be compensated?
For questionnaires:
- €X for each complete set of online questionnaires at baseline, Week 12, and Week 24
- €X for each weight and safety questionnaire at Week 6 and Week 18
For blood tests:
- €X for each of the 3 blood tests
Travel and meal reimbursement (for clinic visits):
- Public transport: Up to €100 with receipt
- Car travel: €0.20 per kilometer
- Meals: Up to €X if your trip and clinic stay exceeds 4 hours
Equipment to keep:
- Digital weighing scales (worth €37.99)
- Blood pressure monitor (worth €47.99)
Total compensation up to [$X TOTAL AMOUNT] plus travel/meal reimbursements plus equipment. Payments are provided via vouchers from Wunschgutschein.de for questionnaires and blood tests. Travel reimbursements are paid directly to your bank account.