How do I participate?

If you are interested in participating in the BETA study, please use this link to provide your contact information and answer a few pre-screening questions to see if you’re eligible. You will then be contacted by a study team member via email. If you would prefer to speak directly to a member of our study team please contact: study@4youandme.org.

What is the goal of this study?

The purpose of the BETA study is to test the feasibility of using remote digital tools to predict the function of beta-cells, the cells in the pancreas that secrete insulin, so that in the future these methods can be tested in a larger study of individuals with Type 2 diabetes or prediabetes. The eventual aim of this work is to develop remote digital tools that can predict the health and functioning of the pancreas in people with prediabetes and Type 2 diabetes, allowing personalized treatment approaches to preserve insulin secretion.

Who can participate?

We are currently recruiting 28 participants. To be eligible for the BETA study, you must be:

• 18+ years old

• Have an established diagnosis of Type 1 diabetes

• Have a glycated hemoglobin (HbA1c) below 8%

• Have a body mass index (BMI) between 18-40kg/m2.

• You must own a personally owned iPhone (6s or newer – iOS 15+) or Android smartphone (version 12 or newer) and use this phone to download and use the MyType1Diabetes app along with the provided wearable devices (Oura ring, Empatica EmbracePlus wristband and a Continuous Glucose Monitor (CGM)).

• You must also reside in Northern California as one of your expectations as a participant is to attend two in person research visits at the Buck Institute Clinical Research Unit (CRU) in Novato, California.

How long will the study last?

Your participation is completely voluntary and you are invited to participate in this study for up to 6 months.

What will I do in the study?

This study is a mix of remote research activities and a few in-person visits. If you are eligible, you will sign an in app consent form and be contacted by a study team member via email with further information about the study. If you choose to participate you will be asked to complete the following tasks:

• Wear wearable and smart devices that will be provided to you that will include an Oura smart ring, an Empatica EmbracePlus, and a CGM.

• Complete surveys and tasks daily (an average of 3-5 minutes per day) in the app when prompted and interact with the study app additional features to log your dietary habits, stress, and other factors relating to your condition.

• Attend two in-clinic visits at the Buck CRU where you will complete an Oral Glucose Tolerance Test (OGTT). This will involve a fingerprick blood test, the consumption of a glucose drink, and blood draws performed by a nurse.

• Complete 6 at-home real-world challenges that will involve consuming specific test meals (e.g., high saturated fat or carbohydrate meal vs standard meals that will be provided to you) in the morning with or without a controlled stressors that will be provided for you (e.g., mental math tasks)

• Check in with study staff every 2 weeks and give feedback on your study and disease experience

Will I be compensated for participating in the study?

Yes. Participants can earn up to a total of $400. Participants will receive $150 for each of the two clinical visits to compensate for time and travel to the Buck Institute Clinical Research Unit. In addition, you will receive $100 at the end of the study if you complete at least 70% of your study activities and check-in calls and with your study coordinator. Finally, you will be able to keep your Oura ring.

Who is conducting this study?

This study is being conducted by 4YouandMe (a non-profit organization dedicated to empowering people to better understand their health and increasing the strength of their voices through remote digital health technology), in partnership with the Buck Institute for Research on Aging (a non-profit organization that conducts scientific research into the biology of aging, and Phenome Health (a non-profit organization with expertise in analysis and translation of multiomic data for human health).

Do you have further information for me to read?

Yes! Here is the link to the BETA study frequently asked questions. If you would prefer to speak directly to a member of our study team, please contact: study@4youandme.org