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 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.
- All Nutrisense members receive a free month of dietitian support, which you may choose to use or disregard. Additional support is available for a fee.
- 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: