Nutrisense Research Program

Anyone who meets ALL of the following inclusion criteria is eligible for study enrollment, pending review of exclusion criteria:

• You are or plan to be a member of Nutrisense;
• You are at least 18 years of age;
• You self-reported to meet the screening criteria for one of the four sub-groups we are interested in studying (these range from healthy individuals to those diagnosed with type 2 diabetes).
• You have an NFC compatible phone
• You do NOT meet any of the following exclusion criteria

If one or more of the following criteria applies to you, you are ineligible for study enrollment:

• Type 1 diabetes diagnosis
• Type 2 diabetes diagnosis and taking diabetes medication other than metformin or pioglitazone
• Taking exogenous insulin
• Undergoing Cancer treatment
• Diagnosed or active eating disorder
• Allergy to medical-grade adhesive
• Currently Pregnant
• Reject consent to study participation
• Cancel or fail to pay for your Nutrisense subscription plan

If you are eligible per the above criteria and wish to enroll in our study, please visit nutrisense.io and follow the enrollment instructions.

To participate in the study, your mobile device must be compatible with the Dexcom app. Please find a list of compatible devices on this page. If you are unsure if your device is compatible, please contact [email protected].

No, this study is only available in English and in the United States of America.

Taking part if this research study is entirely your choice. If you do not wish to take part in this study, you can opt-out or revoke your consent. Regardless of what you decide, you will still be able to continue as a Nutrisense member and be able to use Nutrisense’s services.

If you decide to participate in the Longitudinal Outcomes of CGM Use Study:

• The responses you provided in the eligibility survey (called the Medical History Survey) will be used for research.
• You will be supplied with the Dexcom G7 CGM. We will email you and provide information through the Nutrisense app on how to complete the ordering and eligibility-check process. Activation of the CGM will require you to agree to the manufacturer’s Terms of Use and Privacy Policy. Please review these documents carefully.
• You will be mailed three (3) CGM devices per month and the CGM will need to be replaced every 10 days The Dexcom CGM system is for investigational use only, meaning it is to be used by you for this research study only.
• Your CGM will come with instructions on how to apply, cover and activate using theDexcom app, and where to find instructions for integrating your CGM data from the Dexcom app to the Nutrisense app. If you have questions about the process you can contact Customer Support directly within the Nutrisense app.
• The CGM will collect glucose data from your interstitial fluid (this is fluid found in the spaces around cells) and send it to the Dexcom app on your smartphone (the “display device”) via Bluetooth. Then, Nutrisense will request your authentication to integrate with the Dexcom app. Nutrisense will then pull that data from the Dexcom app via an  Application Programming Interface (API) so you can view your glucose data in the Nutrisense App. For any one activated sensor, your data will be available to view in the Nutrisense app after the 30-minute warm up period.
• We will ask you to complete a short survey within the app about your health every three months for the first six months of the study. These surveys are optional and will take about 6-10 minutes to complete.
• Once the first six month study period is over, we will notify you. Unless you decide to withdraw, we will continue to collect your glucose data. This study period is open-ended.
• If you or Nutrisense withdraws you from the study, you can continue to use the Nutrisense app and dietitian support; however, you will be sent the non-study CGM device that all regular members who are not research participants receive.
• If you have been diagnosed with type 2 diabetes, or on glucose control medications, please consult with your doctor before beginning this study.
• Nutrisense will use the CGM data collected through the app, as well as any self-reported information collected through surveys. If you opt in to dietitian support services, we will also use data related to your interaction with your dietitian (such as messages sent between you and the dietitian and dietitian visit notes) for research.

Note: The Dexcom G7 CGMs are United States Food and Drug Administration (FDA) approved devices used to monitor blood glucose levels in people with diabetes. They have not been approved for use in the general population.

**FDA Approval Statuses:

• Dexcom G7‍
• Freestyle Libre 14-Day

If you have general questions, complaints, concerns, or have suffered a research-related injury, please contact the Nutrisense study team at: [email protected]

If you have any questions or concerns about the research that you do not wish to discuss with Nutrisense, you can contact the institutional review board (IRB) who reviewed this study and ensures that the rights and welfare of research participants are protected at:

Salus IRB
2111 W. Braker Lane, Ste 100,
Austin, TX 78758
Phone: 512-380-1244

Yes. You can stop taking part in this study at any time by emailing [email protected] with the following information:

• Subject: Withdraw from Nutrisense Research
• Email Body: include your Nutrisense email account

The Nutrisense Customer Support team will email you back to

1. Confirm that you’ve been withdrawn from the study and
2. Help you manage your subscription as needed

You can also navigate to your Account Settings, scroll down to Research Consents, and tap in to review and withdraw your consent directly in the app.

Once you withdraw, your Nutrisense app will not be compatible with the investigational Dexcom G7 CGM data integration and we will stop all data collection from the Nutrisense app for Research purposes outlined in the Informed consent. You can request the deletion of identifying personal data from Nutrisense by emailing [email protected]. However, Nutrisense cannot withdraw de-identified data that has already been shared with our research partner or from research that is underway or has been completed.

As the study CGMs are only approved for use in the study, you must properly dispose of any unused study devices at this time.

If you are not yet an active Nutrisense member, please visit nutrisense.io and follow the steps below.

1. Navigate to the Nutrisense Website
2. Select Get Started
3. Fill out the required questions  (5-10min)
4. Select a Nutrisense Subscription Plan  and Checkout: Purchase a Nutrisense Subscription plan (3, 6 or 12 month commitment).
5. Complete the Nutrisense Program Health Questionnaire: answer a set of questions to verify your eligibility for a Nutrisense membership.
6. Select your sensor: choose between the default sensor and the research sensor.
7. If you select the study sensor, complete the cohort eligibility survey: answer a survey about your medical history to determine your eligibility to join the study. If you are eligible for the study, you will be shown the electronic Informed Consent to review. If you are not eligible for the study, you will be informed and will continue with the default sensor.
8. Complete the electronic Informed Consent: you will be asked to read the form and provide consent by selecting your opt-in or opt-out choice and tapping submit.

If you are eligible for the study and complete opt-in through the Informed Consent, you will receive three (3) study sensors each month. If you are not eligible for the study, or choose to decline, you will receive two (2) default non-study sensors with your Nutrisense program each month.

Your participation in this study could be terminated without your consent for the following reasons:

• We have reached the recruitment limit for the sub-group you qualify for
• You have failed to pay your Nutrisense subscription fee
• You revoke access to your data from Dexcom or Nutrisense
• Nutrisense becomes aware of inappropriate use of either the app or CGM, or we believe it is in the interest of your safety or wellbeing
• You no longer meet eligibility criteria for the study
• The research is canceled by the FDA or the sponsor

We will contact you directly if you are removed from this study.

It is important for you to know that if your information was shared with a third party before you withdrew from this study, your information will not be returned to Nutrisense. If your information was used in Nutrisense research that is underway or completed, we will not be able to remove that information either. Nutrisense will make sure your information is not used for any new research.

You will not be paid for taking part in this research and all study activities are optional.

Nutrisense is a unique service in that it offers both an app that pairs with a continuous glucose monitor (CGM) to provide you with digital health information and optional 1:1 nutritionist coaching services. The purpose of this study is to learn more about how using a CGM, with or without nutritionist support, impacts health outcomes for healthy individuals, individuals with type 2 diabetes (T2D), and individuals at risk for T2D over time.

We aim to enroll 52,500 participants in this study.

If you are having issues with your sensor and want a replacement, please message our Customer Support team within the in-app chat BEFORE removing the device. They will help you troubleshoot. If the problem persists, the Customer Support team will handle the replacement process for you.

To be eligible for this study, you must be an active Nutrisense member, which means subscribing to a Nutrisense commitment plan. For the duration of the study, you will be billed monthly at the Nutrisense plan rate.

At this time, we only have IRB approval to use the Dexcom G7 investigational-use-only CGM for this research study. If you’d prefer to use a Freestyle Libre CGM instead of a Dexcom CGM, you can:

1. Enroll in a regular Nutrisense program OR‍
2. Participate in a different type of Nutrisense research

If you are injured because of taking part in this research

• If you experience a medical emergency, call 911
• If you are injured or have medical concerns because you are taking part in this study, contact your medical provider and tell them you are participating in this study
• It is important to note that the Terms of Use and Privacy Policy for both your Nutrisense membership and the Dexcom CGM may include statements limiting your rights if you are harmed as a result of using them. This does not release the study investigator, study staff, or Nutrisense for responsibilities from mistakes. You also do not waive any of your rights as a research participant.

How your data will be protected

• While we can’t give you a 100% guarantee your data will be safe, our priority is to make sure your information is handled as confidentially as possible
• Study data will be physically and electronically secured and access to any identifying information (such as name, phone number, email, and address) will be restricted to staff who are trained in handling sensitive data
• If Nutrisense publishes or presents study findings, only data that are aggregated or deidentified information will be included to reduce the risk that someone could discover who you are
• If Nutrisense shares your data with other researchers or third parties, we will not share your name or other identifiable information and we will have agreements in place that will govern what can and cannot be done with your information as well as prohibiting any attempt to try to identify you

If you decide to participate in the Longitudinal Outcomes of CGM Use Study:

• You will be supplied with the Dexcom G7 CGM. You will receive onboarding instructions via the web, the Nutrisense app, and email on how to set up Nutrisense with Dexcom (a third party).This will require you to agree to the manufacturer’s Terms of Use and Privacy Policy. Please review these documents carefully.
  
  
• You will be mailed three (3) CGM devices per month. The CGM will need to be replaced every 10 days. This investigational-use-only CGM device is meant to be used for research purposes only.
  
  
• Your CGM will come with instructions on how to attach, cover and activate using the Nutrisense app. If you have questions about the process you can contact Customer Support directly within the app or via email at [email protected].
  
  
• The CGM device will automatically sync with the Dexcom app while you are wearing it via Bluetooth. Your data will then be available to view in the Nutrisense app as long as you have an internet connection. After the 30-minute warm up period, while the sensor is connected, with Bluetooth and Internet available, your data will be available to view in the app.
  
  
• We will ask you to complete a short survey within the app about your health every three (3) months. These surveys are optional and will take about 6-10 minutes to complete.
  
  
• Once the study period is over, you can continue to use the Nutrisense app and nutritionist support. You will also be prompted to participate in continuing research, or return to the non-research sensor. If you decline continuing research, you will be sent the Abbott Freestyle Libre CGM that all regular members who are not research participants receive. (The main difference between the two devices is the Dexcom CGMs last for 10 days each – three total per month – and automatically syncs data to the app by Bluetooth.)  
  
  
• If you have been diagnosed with Type II Diabetes (T2D), or are taking glucose control medication, please consult with your primary care physician before participating.
  
  
• Nutrisense will use the CGM data collected through the app, as well as any self-reported information collected through the app (via logged meals, activities, and notes) and through surveys. If you opt-in to nutritionist support services, we will also use nutritionist notes and guidance for research.

If you have general questions, complaints, concerns, or need technical support, please contact the Nutrisense team at: [email protected].

If you have a medical emergency, please call 911. If you have suffered a research-related injury, get the medical attention you need immediately. We encourage you to notify or consult your primary healthcare provider about participating in the study. If you have general questions, complaints, or concerns related to a medical issue related to this study, please contact our support team [email protected] .

If you have any questions or concerns about the research that you do not wish to discuss with Nutrisense, you can contact the institutional review board (IRB) who reviewed this study and ensures that the rights and welfare of research participants are protected at:

Salus IRB

2111 W. Braker Lane, Ste 100

Austin, TX 78758

Phone: 512-380-1244

If Salus cannot address your questions, and for all other inquiries related to this study, please contact Nutrisense directly at [email protected].

As part of this study, we will be using the Dexcom G7 CGM. This device has been approved for use in people who have been diagnosed with type 1 and type 2 diabetes, but it has not been approved for use in the general population. While participating in the study does not present a potential for serious risk to your health, safety, or welfare, there are a few minor risks you should be aware of. The likelihood of these risks occurring is low.

The physical risks associated with the use of this CGM are small and include discomfort or breakage during insertion, sensitivity or failure of adhesives used with the CGM, and chance of infection during use. There may also be psychological or behavioral risks associated with viewing your CGM data. Finally, there may be risks to your privacy if a data breach occurs, allowing someone to see and/or use your data without your permission. We believe these risks are minimal and not greater than those ordinarily encountered in daily life; however, you should consider them carefully.

To see a full list of anticipated risks, please see the Informed Consent.

You may have additional risks or side effects that we do not expect or know to watch for now. Call the research team or your primary care provider if you have any symptoms or problems.

If you decide to take part in this research, we will collect information about you through our Nutrisense app. This is the tool you have access to by being a Nutrisense member, and it will provide us with information about your daily glucose metrics and any additional diet/lifestyle activities you chose to input (including meal frequency and ingredients, type and frequency of physical activities, and sleep). We will also ask you to complete several short surveys at the start of the study, and a follow up survey every 3 months. Data from these surveys will be used for research purposes. If you decide to work with a Nutrisense nutritionist, we will request additional information about your diet, lifestyle, and the current and past status of your metabolic health. This information will not be used for research purposes, but it is necessary to help the nutritionist provide you with personalized support. You will also be provided with a continuous glucose monitor (CGM) that is specific to this study. It will collect glucose data from your interstitial fluid (this is fluid found in the spaces around cells) and send it to the Nutrisense app.

Use of the study CGM will require you to agree to the manufacturer’s Terms of Use and Privacy Policy. Please review these documents carefully.

This research study is open-ended. We expect that your active research participation (for example, being asked to complete surveys) will last for six (6) months. Once the first six month study period is over, we will notify you. Unless you decide to withdraw, we will continue to collect your glucose data, as well as any meal, activity, and sleep data you provide through the Nutrisense app. You may choose to withdraw from this study at any time. If we learn any new information that might change your mind about being in this research, we will contact you and tell you about it.

Within Nutrisense

• All information generated during this study will be kept confidential in accordance with Nutrisense privacy policies.
• The Investigator and other study staff will use your information for the purpose of conducting the study and publishing results of the study.
• Nutrisense staff may use your de-identified data for the development, improvement, or support of our products and services as described in our Terms of Use. This may include information collected as part of this research.

Outside of Nutrisense

• We will share your de-identified data with the CGM manufacturer Dexcom supporting the study. This means we will not share your name, but we may share the random code assigned to you as described in the How will I be protected if I take part in this research? section above. Dexcom may use such de-identified data to improve its products and develop new products.
• Government agencies, such as the Food and Drug Administration (FDA) and the study IRB (Salus) may review and audit this study, including your study information. This will only happen in the context of a regulatory, privacy, or security compliance review.

No, you cannot purchase or use your own CGMs for use during Nutrisense Research. Because of regulations governing IRB-approved research, you must purchase an investigational-use-only CGM from Nutrisense to enroll in the study. These CGMs are only approved for use in the study. If you choose to withdraw from the study, your Nutrisense account will not be compatible with the investigational Dexcom G7 CGM, and you must properly dispose of any unused study devices.