FORWARD 102 vs MyT1Diabetes

This app is intended for use by participants in the FORWARD 102 study and requires an invitation and activation code from the study site to register. A Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of VX-880 in Subjects With Type 1 Diabetes With a Kidney Transplant. This study has been reviewed and approved by the appropriate regulatory body, e.g. Institutional Review Board (IRB) or Independent Ethics Committee (IEC). Key App Features: - Patient Onboarding – complete study app registration and education - Activities – complete scheduled or on-demand study tasks and assessments - Dashboard – review overall progress in the study and current activities - Resources – view study information in the Learn section of the app - Profile – manage account details and app settings - Notifications – receive in-app reminders - Telehealth – conduct scheduled virtual visits with your study site About THREAD: THREAD’s® purpose is to leverage its clinical research platform to enable studies for everyone, everywhere. The company’s uniquely combined clinical research technology and consulting services help life science organizations to design, operate, and scale next-generation research studies and electronic clinical outcome assessments (eCOA) programs for participants, sites, and study teams. Through its comprehensive platform and scientific expertise, THREAD empowers studies to be accessible, efficient, and centered on the patient.

The MyT1Diabetes app is being used for the ARPA-H BETA (Beta-cell evaluation through data driven assessments) Pilot study conducted by 4YouandMe - a digital health non-profit organization in partnership with the Buck Institute for Research on Aging and Phenome Health. The purpose of the BETA Pilot study is to test the feasibility of using non-invasive, remote digital tools to predict the function of beta-cells, the cells in the pancreas that secrete insulin. This study is being done with individuals with Type 1 diabetes, so that these methods can be tested in a larger study of individuals with Type 2 diabetes or prediabetics. The eventual aim of this work is to develop remote digital tools that can predict the health and functioning of the pancreas in people with prediabetes and Type 2 diabetes, allowing personalized treatment approaches to preserve insulin secretion. If you are 18+ years old, have an established diagnosis of Type 1 diabetes, own and use a Dexcom G7 continuous glucose monitor (CGM), have a glycated hemoglobin (HbA1c) below 8% (64 mmol/mol) and a body mass index between 18-40 kg/m2, you may be eligible to participate. If you decide to participate, after having a conversation with a 4YouandMe representative, you will download the Type1Diabetes App where you will be fully informed of the study details and sign a consent form agreeing to participate. This app will serve as a hub for study participation. Using this app, you can track your study progress, complete surveys and tasks, and connect other mobile apps and wearable devices that will be provided to you that will include an Oura smartring, and Empatica EmbracePlus wrist band you will be asked to use the study app, wear the provisioned wearable devices for up to 5 months, attend 2 clinical research visits at the Buck Clinical Research Unit to complete an Oral Glucose Tolerance Test, complete 6 at-home food and stress challenges that will be provided to you, and communicate with a 4YouandMe Engagement Specialist every 2 weeks to discuss your experience. We expect that using the app for the study will take less than 5 minutes daily. This study has been reviewed and approved by an Institutional Review Board (Advarra).