Introduction and Purpose of the Study
We invite you to take part in a study titled the Tastermonial Glucose Challenge. The purpose of this study is to obtain information on the changes in blood glucose levels in the body, as measured by a Continuous Glucose Monitoring (CGM) sensor, that are associated with the consumption of food/beverages and/or supplements.
You are being offered the opportunity to take part in this study because you are an adult who reports no major illnesses and you have an interest in glucose responses to food/beverages and/or supplements.
Procedures
We will ask you to wear a CGM sensor to collect data about glucose levels in your body. We will also ask you to record the food/beverages and/or supplements you consume using the Tastermonial smartphone app while wearing the sensor.
You will be asked to do the following in the study:
- Answer some questions at the start of the study about yourself and your health history
- Have daily access to a smartphone
- Download the Tastermonial app on your smartphone
- Obtain Abbott’s FreeStyle CGM sensor (Libre 14-day or Libre 2 or Libre 3) through your doctor or through a practice associated with Tastermonial
- Download Abbott's FreeStyle app (LibreLink or Libre 2 or Libre 3) on your smartphone
- Connect the Freestyle Libre app to Tastermonial Libre and give permission to have your CGM data accessed
- Follow instructions on consuming food/beverages and/or supplements and recording them on the Tastermonial app
- Use the CGM sensor for the duration of the study
- Answer a short survey at the end of the study or as needed (under 4 minutes of your time)
Duration of the Study
The duration of your participation in this study will vary depending on the specific Tastermonial Challenge you engage in or other instructions made available.What do I need to do to participate?
Benefits and Risks
While this study does not provide medical advice or diagnosis, one of the primary benefits is that you will receive personalized insights based on your data. These insights, delivered via individualized reports, will help you better understand your blood glucose responses to the foods, beverages, and supplements you consume. This information may assist you in making more informed decisions about your diet and overall health. These reports are designed to empower you with valuable data about your body's unique responses, though they are not a substitute for medical advice.
The results of this study may also help researchers improve their understanding of the relationship between blood glucose levels and various dietary factors, potentially contributing to better health recommendations in the future.
It is important to note that there are minimal risks associated with participating in this study. Possible adverse effects of wearing a Continuous Glucose Monitoring (CGM) sensor may include local redness, infection, inflammation, pain, discomfort, bleeding, bruising, itching, scarring, or adhesive irritation at the sensor site.
Confidentiality and Data Privacy
Tastermonial is committed to protecting your privacy and ensuring that your personal information is handled with the utmost care. We follow strict data protection protocols and exceed industry standards in the collection, analysis, storage, and use of your data. Your private information, including demographic data, will never be shared in a way that identifies you. All data shared with external parties will be fully anonymized, ensuring that your identity remains protected.
To further support your health journey, Tastermonial is dedicated to empowering you with access to your data. At any time, you may request an export of your data from the Tastermonial app by writing to study@tastermonial.com. We are also committed to providing valuable insights through personalized reports, helping you better understand your health metrics and responses to food, supplements, or lifestyle choices.
All data collected will be de-identified and encrypted, with each participant assigned a unique ID. Only anonymized data will be shared with select research partners or used in future studies without additional consent. In any publication or presentation resulting from this study, no personally identifiable information will be disclosed.
Our mission at Tastermonial is to crowdsource information that advances the knowledge of nutrition and public health while providing individuals with tools and insights to better manage their own health.
Your Data Access Rights
As a participant in this study, you have the right to access the data collected about you. Tastermonial believes in transparency and empowering individuals with their health data. You can request an export of all your data from the Tastermonial app at any time by contacting us at study@tastermonial.com.
You will also have access to personalized reports that summarize insights from your data, which may help you understand your glucose responses and how different foods, beverages, or supplements impact your health. This information is provided as part of our commitment to empowering you with knowledge and insights based on your participation in this study.
We will do our best to provide you with valuable, actionable insights from your data, but please note that these are not medical diagnoses or personalized treatment recommendations. You should always consult with a healthcare professional before making significant changes to your health or diet based on these reports.
Cost for Participation
There is no cost to participate in the study. The CGM sensor you obtain through a prescription from your doctor or through a medical practice associated with Tastermonial may or may not be covered by your medical insurance. The typical out-of-pocket cost for a CGM sensor is around $60.
Compensation for Participation
Depending on the specific challenge, you may or may not be compensated for your participation in the study. But free samples of food/beverages and/or supplements might be provided and delivered to you at no cost.
Study Funding
Tastermonial is currently receiving compensation for some of its studies. If you are accepted to participate in a sponsored study (the challenge), we will provide you with the full disclosure.
Voluntary Participation and Withdrawal
Taking part in this study is entirely voluntary. The alternative is not to participate in this study. If you choose to take part, you have the right to stop at any time. If you decide not to participate or if you decide to stop at a later date, there will be no penalty for doing so. If you decide to participate you must electronically sign this form to show that you want to take part.
Contact Information for Questions or Concerns
You have the right to ask any questions you may have about this study. If you have questions, complaints or concerns now or during the study, please contact the PI, Guillermo Repizo, PhD at study@tastermonial.com.
Signature and Consent
I voluntarily give my consent to participate in this study. I may opt-out at any time without penalty. I have read the information above or the information was read to me. I was given the opportunity to ask questions and these were answered to my satisfaction.
You will receive a copy of the signed and dated form for your reference.