SENSE-T2D risk study
Sensor-based Evaluation of Negative States and Experiences in people at elevated risk of type 2 diabetes, including prediabetes and obesity
SENSE-T2D risk
You can take part in the study,
if you:
- are between 40 and 60 years old;
- suffer from prediabetes or obesity OR have an increased risk of type 2 diabetes (learn more about diabetes risk factors here)
- can read and write German or English
- own and use a smartphone;
- are willing and able to wear a Freestyle Libra 2 CGM and an Oura Smart Ring or a Garmin vívosmart Smartwatch.
Unfortunately, you cannot participate,
if you:
- suffer from type 2, type 1 or gestational diabetes,
- are pregnant;
- are currently experiencing a depressive episode;
- are currently suffering from a psychosis.
Find out more about your risk of type 2 diabetes
Background of the study
Why do we want to better understand daily mood and mental health in people with prediabetes, obesity, or at higher risk for type 2 diabetes?
We want people with prediabetes, obesity, and at higher risk of type 2 diabetes to live as happy and healthy a life as possible. If we can better understand how behavioural, biological, and emotional factors contribute to better or worse daily mood or mental health, it will help us to understand how we can improve the daily lives of people at higher risk of type 2 diabetes. In the future, this could even help us to develop mental health interventions that are precisely tailored to people at higher risk of type 2 diabetes. To do this, we need to better understand these factors, and you could help us to do that.
How can wearable devices help us to better understand mental health in people at with prediabetes, obesity, or at high risk for type 2 diabetes?
Wearable devices (such as smart rings, smartwatches, and continuous glucose monitors) and personal digital devices (such as smartphones) can help us to access important behavioural, physiological, and emotional information about people as they go about their daily life. Wearable rings and watches provide information on activity, sleep, and heart rate, continuous glucose monitors provide information on glucose variability, and smartphones can allow us to ask daily questions (such as, how happy do you feel right now).
In the past, we could only get this information by asking a person in a survey or when they come to the clinic questions like “how much sleep do you feel you get in general?” This is not a very precise way of understanding how much someone sleeps each night. With new technology, we can access data on how much a person sleeps each night, how much activity they engaged in that day, and how their mood was, and then see how these factors are related.
Importantly, these devices can record important information as a person lives their daily life, with very little needed from the participant. Other than a few pop-up questions on the smartphone app, the devices run in the background. This allows rich mental and physical health information to be collected without a lot of burden to the person. This has a lot of potential for healthcare monitoring and interventions that can reach as many people as possible.
Study Participation Procedure
1. Telephone call
After you indicate you are interested, we will arrange a quick call with one of the study researchers. They will confirm you are eligible and answer any questions you might have about the study. They will also arrange for you to come to the clinic to receive the devices.
2. Clinic visit, questionnaires, and device set up,
We will then invite you to visit us at the University clinic in Tübingen. Here, we will ask you to complete some questionnaires about your health and behaviour and we will measure your HbA1c (an indicator of average blood glucose levels over a few months) with a quick finger prick test. The study researcher will then provide you with 1) either a smart ring OR a smart watch, 2) a continuous glucose monitor; and 3) the smartphone app. The researcher will show you how to use each device and answer any questions you have.
3. Digital Health and Behaviour Monitoring
You will then wear the devices for 30 days. Twice a day you will receive a short survey in the smartphone app. This will ask you about your mood and experience. It should not take longer than a few minutes to answer the questions. If you have any issues with any of the devices, the study researcher will be available by phone, text, or email to assist you.
4. Clinic visit, questionnaires, and return of devices
After 30 days, you will be invited back to the clinic to return the devices. You will also complete some questionnaires and be asked for your feedback on taking part. We are very interested in your thoughts and opinions about the study and what it was like to take part. You will be told about future plans for the study and how you can stay up to date on the findings.
Thank you!
As a thank you for your participation, you will receive a €15 WUNSCHGUTSCHEIN.de shopping voucher at the end of the monthly surveys.
FAQ
FAQ
How many in-person appointments are planned as part of the study?
The study includes 2 in-person appointments, at the beginning and end of the 30 day collection period which will take place at the University Clinic in Tübingen. These will be around 30-45 minute.
All other surveys will be conducted digitally via your smartphone.
Can I terminate the study at any time?
Yes, you can revoke your consent at any time, either verbally or in writing, without giving reasons, and without any disadvantage to you. If you revoke your consent, no further data will be collected. You can also request at any time that your data be deleted or anonymized so that it can no longer be linked to you. Deletion of already anonymized data is not possible, as the origin of the data will then no longer be recognizable.
Is my data secure?
Your data is documented and archived pseudonymously in a protected electronic database.
Kontaktieren Sie uns
Contact
frontend.sr-only_#{element.icon}:
Department of Population-Based Medicine
Röntgenweg 9
72076 Tübingen
|
Principals Investigator |
Dr. Amy McInerney |
|
Study coordinator |
Katharina Knaub |
|
Research Assistant |
Valerie Haydt |
frontend.sr-only_#{element.icon}: +49 7071 29-86170
E-mail address: senseT2D@med.uni-tuebingen.de