September 30, 2021
University of Michigan PROviding Mental Health Precision Treatment (PROMPT) Digital Clinical Research Study
Clinical Trials & Research
May 25, 2022
The Scripps Research Digital Trials Center launched the PRediction Of Glycemic RESponse Study (PROGRESS) as part of their efforts to understand metabolic health and diseases like type 2 diabetes. CareEvolutions’ MyDataHelps™ digital clinical trial and research platform is utilized for recruitment, screening, electronic consent (eConsent), engagement, and retention, and it integrates data collected through electronic patient-reported outcomes (ePROs), wearable devices, electronic health or medical records (EHR/EMR), and kitting fulfillment.
Type 2 diabetes (T2D) is a highly prevalent chronic disease found in approximately 13% of all adults in the United States. A significant risk factor for T2D is obesity, which plagues nearly 40% of US adults and, at the population level, is greatly impacted by nutrition intake. However, the specific link between nutrition, obesity, and subsequent T2D risk is unknown on an individual level.
The recent shift towards exploring variables such as food intake, genetics, and other physiological measures and their relationship with the onset of T2D or pre-diatebetes has led to the burgeoning field of precision nutrition. Enabled by digital health platforms, clinical studies are now able to collect a sufficient depth of real-world data to investigate these relationships. With sponsorship by Tempus, the Scripps Digital Trials Center’s PROGRESS is leveraging the power of CareEvolution’s MyDataHelps™ digital clinical trial platform to study the impact of dietary intake on glucose response. Overall, the study intends to use data collected through ePROs (health, lifestyle, and nutrition intake), digital endpoints, electronic health records (EHR), and biosamples to develop a predictive model that accounts for individual multi-omics, physiologic, clinical, and lifestyle information.
Participants to Date
Participants Share EHR
PROGRESS aims to enroll 1000 participants 18 years old and up, half of whom have type 2 diabetes and half without the disease. Participants will also be able to self-report their status as pre-diabetic.
A rich array of participant data is collected on PROGRESS participants:
Data collection is split into two main phases: an active and a passive phase. During the active data collection phase, ePROs and biosamples are collected and the participant shares their EHR data and connects to the study-provided trackers and sensors. During a specified 10-day data collection period, participants are asked to continuously wear their CGM and Fitbit and to track their food and drink intake with precise timing. After the active collection phase is complete, participants can still passively share their EHR and wearable data. Ultimately, the Scripps Research team will use the glycemic response outcome data to develop a predictive model that incorporates individual features.
CareEvolution’s MyDataHelps™ digital clinical trial and research platform integrates data collected throughout the active and passive phases of PROGRESS and facilitates participant engagement and retention.
Pre-study period: People interested in participating in the study are directed to download the MyDataHelps app and complete a “screener” survey. If they are eligible to participate, they are then provided eConsent and, upon enrollment, prompted to complete ePROs, share their EHR data, and connect to the trackers and sensors used in the study all within the app. MyDataHelps™ also enables automated email and push notification reminders for any incomplete activities. Additionally, participants are able to request a biosamples kit to be delivered to their home through MyDataHelps™.
10-day study period: CGM, Fitbit, and food and drink data collected during the 10-day study period is continuously integrated through the MyDataHelps™ app. In addition, participants receive push notifications throughout this period that serve as reminders. Within the app, participants can also view their individual glycemic response to various foods.
During the 3 years of follow up, participants can continue to use the MyDataHelp™s app to view their personal results. They may also opt to provide a yearly blood draw and continue to share EHR data (they may be prompted to refresh this connection annually), coordinated through MyDataHelps™.
Participant engagement and retention
In addition to data integration, MyDataHelps™ functionality enables PROGRESS participant engagement and retention through an incentives feature. Participants earn points throughout the study by completing tasks, including ePROs, collecting biosamples, and connecting their Fitbit. At various thresholds, participants can then elect to redeem their points, triggering an automated gift card delivery through MyDataHelps’ connection to the Amazon Gift Card API. This allows for flexibility in when and how points are awarded that can then be converted to a reward.
PROGRESS will continue to enroll people in their diabetic and non-diabetic cohorts until their goal participation has been reached. Ultimately, the data collected through PROGRESS are a valuable tool for precision nutrition research.