What is the goal of this study?

The BETA study is designed to explore how remote digital tools, such as wearable devices and continuous glucose monitors, can be used to predict the function of beta-cells, the cells in the pancreas that secrete insulin. The eventual aim of this work is to develop a real-time, non-invasive predictor of pancreatic beta-cell function for individuals with prediabetes or Type 2 diabetes allowing for personalized treatment approaches to preserve insulin secretion

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.

Who can participate?

We are currently recruiting 130 participants. To be eligible for the BETA study, you must be:

• Be 18+ years old.
• Have an established diagnosis of Prediabetes or Type 2 diabetes.
• Have a glycated hemoglobin (HbA1c) below 8% in the last 6 months.
• Have a body mass index (BMI) between 18-40kg/m2.
• Own a personal iPhone 6s or later (iOS 16.4+ or newer) or Android smartphone (version 12 or newer) and be willing to use this phone to download and use the BETATrack app along with the provided wearable devices (Oura ring and a Continuous Glucose Monitor (CGM)).
• Be willing to use the study wearable devices (e.g., Oura ring, Abbott FreeStyle Libre 3/3+ Continuous Glucose Monitor (CGM)) supplied by the study and provide the study investigators access to the device data.
• Own a personally owned computer at home that is able to do video calling in order to complete the at-home Challenges.
• Reside in Marin/Sonoma County or the North San Francisco Bay area 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.

Why should I participate?

 By participating in the BETA study, you will gain valuable insights into your health and condition while contributing to research that may allow for personalized treatment approaches to preserve insulin secretion, and improve overall care for those with Prediabetes or Type 2 diabetes.

As a participant, you may benefit from:

• A deeper understanding of your condition
  • Learn how your daily habits such as sleep, food, stress and activity may affect your blood sugar and overall health.
• Access to wearable devices
  • Use a study-provided continuous glucose monitor and Oura Ring to track your glucose levels, sleep, activity, heart rate variability (HRV), and other key metrics.
• Personalized self-exploration
  • Work closely with your engagement expert to explore what factors may trigger personal glucose excursions and identify your personal patterns.
• Dedicated study support
  • Have a direct connection to a member of the study team who can guide you, answer your questions, and help support you throughout your study journey.

Your participation in the BETA study helps advance diabetes research while empowering you with tools and knowledge to learn more about and better manage your health.

How long will the study last?

Your participation is completely voluntary and you are invited to participate in this study for 6-8 months.

What will I do in the study?

This study is a mix of remote research activities and 2 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:

• Use wearable smart devices that will be provided to you that will include an Oura smart ring and continuous glucose monitors.
• Participate in bi-weekly check-ins with your study support coordinator that will focus on your study experiences and self-explorations around what modifies your glucose excursions.
• Complete surveys and tasks daily (an average of ~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) and a Meal Tolerance Test (MTT). Both the OGTT and MTT will involve a fingerprick blood test, the consumption of a study-provided drink, and an IV placement for blood draws performed by a nurse over 3 hours.
• Complete up to four at-home 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.
• Complete up to eight (8) 4-day recording periods throughout the 6 month study, with detailed dietary intake records and co-design of intentional lifestyle variations (e.g., physical activity) with your clinical research engagement experts.

Will I be compensated for participating in the study?

Yes. Participants can earn up to a total of $600. Participants will receive $150 for each of the two clinical visits to compensate for time and travel to the Buck Institute Clinical Research Unit. You will also receive up to $300 as determined by at-home adherence. 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