What You Need to Know to Participate

Study Title	How Does YES Bar Affect Blood Glucose Levels?
Principal Investigator	Matthew Amsden
Sub-Investigator for Safety	Viral Patel, MD
Study Author	Brennan Spreitzer, Matthew Amsden
Total Cost to Participant Purpose	$67 To understand how YES Bars affect blood sugar levels using continuous glucose monitoring (CGM).
Outcome Measures	Baseline and post-snack blood glucose readings to assess glycemic impact over four to six separate days
Included Products	YES Bar 6-Bar Variety Pack, Abbott Lingo CGM & App
What You’ll Do	Use a CGM to monitor blood glucose before and after eating YES Bars and a control snack, following a structured timeline.
Study Length	Approx. 7–10 days with about 15-20 minutes of active effort on four days and two optional days.
Your Responsibilities	Follow fasting and eating instructions, log glucose data, and report any issues to help@efforia.com.
Compensation	A gift card will be provided upon completion.
Possible Benefits	Potential personal insights about your response to YES Bars and may help expand scientific understanding of diet and glucose.
Risks	Possible allergic reaction; mild pain.
Medical Support	Efforia does not offer direct medical services or emergency response capabilities. Seek help from a healthcare provider or 911 in emergencies.
Privacy	Your data is protected, but no system is risk-free. See https://efforia.com/privacy-policy.
Voluntary Participation	Participation is optional. You may withdraw at any time without penalty.
Questions?	Email: help@efforia.com Phone Number: (646) 679-2479  Or click the chat button on your screen

👍Please review this table above for a summary of key details. Read the full document below for complete information.

Introduction and Summary

Welcome to this research study on the Efforia platform, made possible by your support through participation and financial contribution. This document will help you understand the study, its purpose, and your role, so you can decide whether to take part. Participation is voluntary, and you may leave the study at any time without penalty. Please ask any questions  you may have before proceeding.

Efforia is a citizen science platform where research studies are supported by you, the participants. Unlike regular research studies, you pay for all the supplies, services, information, and tools needed for participation at one time. This way, we can do studies that might not be possible otherwise.

Although you could buy these products and services separately for a similar cost, Efforia bundles them into one purchase for convenience. Efforia organizes these items and provides instructions to create a complete, data-driven research experience. This setup allows you to track and understand the impact that participating in the study may have on your own life through detailed reports, making it easier to make informed personal health decisions. It also helps advance research that can benefit others who might not be able to afford these products without guaranteed results.

Efforia is committed to equal participation. If the $67cost of the YES Bars and the glucose monitor is too high for you, click the large Efforia logo at the top of the screen to explore other study opportunities. Efforia offers studies on various topics at different price points, including free options, so you can find one that suits your goals and budget.

Purpose of the Study

The purpose of this study investigates how YES Bars affect blood glucose levels and aims to contribute to scientific knowledge on dietary impacts on glucose. You will be asked to use the Abbott Lingo Continuous Glucose Monitor (CGM) and app to track glucose changes while consuming YES Bars and a control snack. This research could benefit society by providing insights into managing blood glucose levels through dietary choices.

The number of participants in this study will be determined by the number of people willing to sign up.

What You Will Do as Part of this Study

While participating in this research study, you will need to:

• Be willing and able to follow the study directions and procedures
• Tell Efforia about any side effects or problems by communicating with help@efforia.com or online chat.
• Ask questions as you think of them, via help@efforia.com or online chat.
• Inform Efforia if you change your mind about staying in the study. You may leave the study at any time by communicating with help@efforia.com or via online chat.

If you agree to participate in this study, you will be asked to  use an Abbott Lingo CGM to monitor glucose levels while consuming YES Bars and a control sweet snack. The Abbott Lingo CGM is worn on your upper arm and offers glucose tracking via an app. 

You will be asked to eat at least four YES Bars on separate days over 7 to 10 days following a timeline and to record your glucose responses. You will begin by eating a favorite sweet treat to establish a baseline and observe its effects on your glucose levels. You will wear the CGM device and manually enter glucose data into the app. 

The schedule includes eating YES Bars on at least four separate days, with each session requiring a 1.5 to 2-hour fasting period before you eat the YES Bar in order to make sure you get an accurate baseline reading. You must log your glucose levels immediately before and after consuming the bars and the control snack. You are encouraged to enter additional data such as sleep quality, stress levels, and recent physical activity, as these factors can affect glucose responses.

You will also have the option to consume two additional YES Bars and log your glucose levels.

Following the timeline and instructions are important to make sure the study results are reliable. 

Will There be Any Costs?

You will be responsible for certain costs related to your participation in this study, such as the $17 cost of the YES Bar 6-Bar Variety Pack and the $49 cost of the Lingo Continuous Glucose Monitor (CGM) and app by Abbott. If you have any questions about the costs associated with this study, please contact Efforia.

Will I be Paid for Participating?  

You will not be paid for participating in this research study, but after you complete the study you will receive a $17 gift card you can use for your next purchase of YES Bars.

Personal and Overall Findings

Efforia will provide you with both personal outcomes as well as overall study findings. These findings will be made available at various points during the study or as they are discovered by Efforia. The results and findings may impact your interest and willingness to stay involved in the study. Participation is voluntary and you may stop the study at any time by e-mailing help@efforia.com.

Benefits of Being in the Study

Participating in this study may offer a chance to gain insights into how your body responds to specific foods, potentially leading to more informed dietary choices. Your participation may also contribute to broader scientific understanding, which can help others manage their glucose levels. However, there is a possibility that there will be no measurable benefit to you, other than seeing reports that the intervention or treatment had no measurable impact.

Risks Related to Study Participation 

It is your responsibility to weigh the risks and benefits and decide if you should participate. You are encouraged to consult with your healthcare providers and conduct further research before enrolling in the study.

Known Risks

It is expected that the study will pose no more than minimal risk to you.  Side effects that are known to be associated with YES Bars include: 

Allergic Reaction:  Signs of an allergic reaction may include rash, flushing (reddening of the skin), itching, sneezing or runny nose, coughing or wheezing, diarrhea, vomiting, and swollen lips, eyes, face, or throat.  Anaphylaxis is a severe, potentially life-threatening allergic reaction.  Signs of anaphylaxis may include hives, itching, flushed or pale skin, low blood pressure, swollen tongue or throat which can cause wheezing and trouble breathing, weak and rapid pulse, nausea, vomiting, diarrhea, dizziness, or fainting. 

Side effects that are known to be associated with the Lingo Continuous Glucose Monitor (CGM)  include mild pain (rare).  

Possible Risks

The following risks are theoretically possible but have not been observed with any frequency: Infection at the Lingo application site.

For your safety, you should not participate if you have any of the following conditions: You should not enroll in this study if you are diabetic as the device is not approved for blood glucose management in diabetics. The user is not intended to take medical action based on the device output without consultation with a qualified healthcare professional . This System is NOT intended for diagnosis of diseases, including diabetes.

Serious Adverse Reactions

If you experience any severe or concerning symptoms while participating in this study, please seek immediate medical attention by dialing 911. After receiving needed care, please contact Efforia using the information on the first page of this document to report the incident. This will help us track the safety and effectiveness of the treatment product and support ongoing research efforts.

Efforia's limitations in providing direct medical support

Efforia does not offer direct medical services or emergency response capabilities. You are encouraged to maintain contact with your healthcare provider for advice and treatment of any medical conditions or symptoms experienced during the study.

Privacy and Security Risks

Your research records will be kept confidential to the extent permitted by applicable laws and/or regulations. Efforts will be made to keep your personal information private, however, total confidentiality cannot be guaranteed. The results of this study may also be published or presented at medical meetings, but your identity will not be disclosed.  

You should review the Efforia general privacy policy, which is available here: https://efforia.com/privacy-policy/

Personal information may be collected through the use of the Lingo app.  The Lingo Privacy Policy may be found at: https://www.hellolingo.com/privacy-notice   The terms may appear to limit your legal rights, but you do not give up any legal rights by signing this form. 

There are certain limits to the rights of your privacy:

• We may reach out to local help if we have reason to believe you may be a harm to yourself and/or others.
• Regulators, like the US Food and Drug Administration (FDA) or similar agency, or Institutional Review Boards may review records that have your identifying information.

What to do if you have a study related injury

If you experience a study-related injury, seek local medical care first, if necessary. Efforia cannot provide emergency medical care. However, it's important to contact Efforia if you experience any problems, have any side effects, or have a study-related injury after you've received the necessary treatment. You can contact Efforia at the contact details in the beginning of this consent. 

Study related injury care and compensation

Efforia does not plan to offer financial compensation nor to absorb the costs of medical treatment should you be injured as a result of participating in this research. Efforia makes no commitment to provide free medical care or payment for any unfavorable outcomes resulting from participation in this research.

In the case of medical emergency

In the case of medical emergency please dial 911 immediately. You should contact Efforia after the emergency has passed.  If at any time during the study you have any thoughts of hurting yourself or someone else, you can call the toll-free 24-hour National Suicide Prevention Lifeline at 1-800-273-TALK (8255) or call or text 988.

Alternatives to Participating in the Study

This study is not for treatment purposes.  You do not have to take part in this study. The alternatives are you may use YES Bars and/or the Abbott Lingo Continuous Glucose Monitor outside of your participation or you can choose not to participate. 

Your Rights as a Participant

Your participation in this study is completely voluntary, and you are free to withdraw at any time without any consequences. You are not giving up any rights by signing this document.

Right to Your Own Results

You have the right to a complete explanation of the research once your participation has ended.

The Right to Leave a Study without Penalty at Any time

If you decide to withdraw from the study, you can do so at any time by visiting your Profile page, selecting "Your Protocols," and clicking "Leave." Upon leaving the study, you will be refunded for any consumable products that have not yet been shipped. For non-consumable products, a full refund will be issued upon the return of the product in accordance with our return policy. This ensures that you can participate in the study and that your purchases are handled fairly.

We will tell you of any information learned during this study that might cause you to change your mind about continuing to take part.   

Conflict of Interest Statement

As part of our commitment to ethical conduct and openness in our citizen science clinical trial, it is important to explain the unique structure of our study. This clinical trial is hosted by Efforia, but it is uniquely sponsored by you, the participants. Efforia serves as the platform provider and does not sponsor or influence the study outcomes.

Efforia takes a transaction fee on all the products and services included in this study. Otherwise, we have no financial interest or conflicts of interest. To further reduce conflicts of interest, we will remind you once if you do not complete enrollment in this study. We will not remarket to you, nor otherwise push you to join the study.

How we Reduce Conflicts of Interest

It is important that participants do not have any financial relationship with the intervention methods or measurement providers used in the study, nor should they be employees, investors, stakeholders, or protocol authors associated with these entities. Participation under such conflicts of interest could significantly affect the study's integrity and results.

Consequences of Conflict of Interest Non-Compliance

Should you fail to disclose such a conflict of interest or if a breach of this policy is discovered, you will be subject to immediate suspension from this platform and payments may not be refunded.

By joining this study, you affirm that you understand the above conflict of interest restrictions and agree to follow them. Your participation is valued, and your commitment to following these guidelines helps make sure that our collective scientific efforts are accurate and reliable.

Data Protections

Data will be collected, used, and protected in compliance with data protection laws.

What you can do to improve your privacy and security:

As part of participating in this study, you will receive notifications via e-mail, SMS, or push notification when new study tasks like questionnaires and reminders are ready for you. You can adjust your communication preferences in the Efforia application at any time. If you do not want to receive notifications from this study, please do not press the Accept button. You can decide not to join this study, and will not receive notifications. To ensure others don’t see these alerts, you should make sure your phone or desktop computer and your e-mail accounts are protected by a password, pin, or other form of “access control.” You should also avoid sharing your accounts with others or sharing your account passwords.  You can learn more about Your Privacy and Security rights on Efforia here: https://efforia.com/privacy-policy.

Who will have access to your data?

Efforia will have access to your data. There may also be partners who have access to your data, such as connected health devices.

What will we do with your data

We will use the data to show you your own personal results and pool your results with other participants to provide general outcomes. We will not use your information connected with your name or anything that connects the data with you without your permission.

California Experimental Research Subject’s Bill of Rights

Information about the California Experimental Research Subject Bill of Rights is available on Efforia. You can find the Efforia privacy policy here.

A description of this clinical trial will be available on https://www.ClinicalTrials.gov, as required by U.S. Law.  This Web site will not include information that can identify you.  At most, the Web site will include a summary of the results. You can search this Web site at any time.

Who to Contact for Questions or Concerns

If you have questions, concerns, or complaints about this study or to report a study-related injury, contact:

Email: HELP@EFFORIA.COM
Phone Number: (646) 679-2479
OR CLICK THE CHAT BUTTON ON YOUR SCREEN

If you are unable to reach anyone with the contact information listed above and you require immediate (life-threatening) medical attention, please go to the nearest emergency room. 

An institutional review board (IRB) is an independent committee that helps to protect the rights and welfare of research participants. If you have any questions about your rights and welfare as a research participant, or have concerns or complaints regarding this research study, please contact Univo IRB at (919) 910-7743 or via email at info@univo-group.com.