Moving Data Towards Solutions
The Leona M. and Harry B. Helmsley Charitable Trust’s (Helmsley) Type 1 Diabetes (T1D) Program is launching a Request for Proposals (RFP) to support the development of novel, real-world solutions to help people with T1D exercise safely and to improve their quality of life. Researchers and clinicians are expected to partner with statistical teams to analyze the real-world data that was collected under Helmsley’s T1D Exercise Initiative (T1-DEXI), build collaborations with other necessary third parties, and to test their novel solutions in studies with people with T1D. The overarching purpose of this initiative is to move real-world data towards real-world solutions.
In people with type 1 diabetes (T1D), glycemic response to exercise is highly variable, both within and among individuals, often increasing the risk for hypoglycemia and hyperglycemia. The reason(s) behind this variability is largely unknown. While continuous glucose monitors (CGMs) and automated insulin delivery (AID) systems hold promise for improved glycemic control during and after exercise, limited research has been conducted outside of a controlled clinical setting.
To address this gap, Helmsley collaborated with the Jaeb Center for Health Research (JCHR) and a group of investigators to conduct two large observational exercise studies, one for adults (T1-DEXI) and one for pediatrics (T1-DEXIP). While initial investigator-led analyses have been conducted on a subset of study-assigned exercise events (ADA abstracts #1, #2), the majority of the data is yet to be analyzed.
One of the major outputs of this effort is publicly available data sets, which can be accessible via Vivli, a platform for sharing clinical data. This data is a unique resource to further research, to develop innovative solutions, to improve decision support tools, and to improve automated insulin delivery algorithms. The genotype data, which will be included in the coming weeks, may also provide an opportunity for the data from these studies to be combined with other publicly available data sets and further expand potential use in line with Helmsley’s T1D program’s data sharing goals.
T1-DEXI: The adult study collected 4 weeks of real-life data from approximately 500 people with T1D between the ages of 18 to 70 with T1D wearing a Continuous Glucose Monitor (CGM), using automated insulin delivery (AID) systems, insulin pumps, and multiple daily injections (MDI). During the 4-week real-world observational exercise study period participants were asked to complete at least 150 total minutes of activity per week and use the data collection tools. In addition to typical activity and exercise, each participant was assigned to complete a structured study exercise types: aerobic, high-intensity interval training, or resistance.
T1-DEXIP: The pediatric study was designed to collect 10 days of real-world data from 250 youth with T1D between the ages of 12 to 17 using CGM’s, AID systems, insulin pumps or MDI. 50 of the participants are new onset.
Both study designs include (but are not limited to) the collection and aggregation of the following data around structured and unstructured exercise:
NOTES:
*The Vivli Platform will only have processed activity data. If algorithm research groups are interested in accessing raw activity data (protobin), please contact ddalton@Helmsleytrust.org separately.
Pertinent study resource documents and a metadata file describing dataset contents are available in the Vivli platform. See CDISC section below for additional information.
The links for the study protocols are here: T1-DEXI and T1-DEXIP.
Helmsley partnered with the Clinical Data Interchange Standards Consortium (CDISC) and T1D experts to expand upon existing diabetes standards and to develop new data standards for Type 1 Diabetes exercise, nutrition, pediatrics, and devices. As part of the Helmsley T1D Program’s data sharing goals, these data standards were used for subsequent T1-DEXI and T1-DEXIP Study Data Tabulation Model (SDTM) tabulations as provided. Collaboration and subsequent efforts are meant to encourage the use of controlled terminology, promote interoperability and data re-use, and increase operational efficiencies in combining data sets. We encourage applicant teams to include a statistician, bioinformatician, engineer, data manager, or a colleague with other similar expertise.
Serving as the data dictionary, a Define-XML metadata file describing the contents of each SDTM data set is provided at the Vivli platform. Additional study documents available to support use of the SDTM data sets include: study protocol, annotated CRFs, and a Study Data Reviewer’s Guide.
Helmsley partnered with Vivli to make the T1-DEXI and T1-DEXIP data sets publicly available and easily accessible. Vivli is an independent, non-profit entity whose mission is to promote, coordinate, and facilitate clinical research data sharing through a global clinical research data sharing platform. The Vivli team is dedicated to helping researchers share and access data from clinical trials to advance science. Furthermore, the Vivli platform hosts other T1D data sets that can be combined with T1-DEXI data. Vivli is also one of six generalist repositories that will work with the National Institute of Health (NIH) Office of Data Science Strategy (ODSS) as part of the Generalist Repository Ecosystem Initiative (GREI).
Helmsley T1D Program seeks to fund studies that lead to solutions that improve management of exercise with T1D in the real world. The goal of the projects should be learning from the T1-DEXI data to provide people with T1D and healthcare providers practical management solutions for T1D and exercise and to improve clinical guidelines in a way that can be applied in the real world. All potential projects are expected to include a study component involving people with T1D.
The following are examples of project ideas that could be applicable for this RFP, however applicants are also encouraged to propose new research directions that may not have been exemplified here:
NOTE: Excluded from the scope of the funding opportunity are (a) resources to initially look at the data sets and develop the Concept Note for the RFP (b) studies primarily focused on animal model-based activities.
NOTE: Timing of the RFP process is subject to change.
Phase 1: September 2022 – April 30, 2023 (7 months)
Accessing and Exploring the T1-DEXI data sets via Vivli Platform, Registering the Organization with Helmsley Grants Management System & Submitting a Concept Note by April 30, 2022
Phase 1A – Register with Vivli
NOTE: Applicants MUST use the T1-DEXI and/or T1-DEXIP data sets as part of their basis for the proposal. This is a pre-requisite for submitting a Concept Note (due April 30, 2023).
Phase 1B – Register with Fluxx and Submit a Concept Note
Phase 2: May 2023 – June 30, 2023 (2-3 months)
After review of Concept Notes, selected applicants will be invited to submit Full Grant Proposals, which will include, but not be limited to:
Helmsley staff will review submitted material. Helmsley may choose to engage external advisors in the review process.
Additionally, if there are algorithm research groups interested in raw data files from the Study Watch, please contact Helmsley (ddalton@helmsleytrust.org) in addition to completing steps above.
Applicants should complete the requested information in Fluxx AND upload a Word document or PDF (with figures) of no more than 1,200 words (figures do not count against the word limit) addressing the topics below.
The proposed funding term can be up to three years. If additional years are required, describe the project in stages, with the first stage lasting up to three years. Requested funding amounts can range, based on activities, but should not exceed $3M over three years. If the research plan cannot be executed within the funding opportunity’s boundaries, justify an alternative in the Concept Note. All funding decisions are subject to approval by Helmsley’s Board of Trustees.
Proposed projects will be assessed based on:
Any individual with a faculty-level (or equivalent) appointment at an institution performing medical research, with the skills, knowledge, and resources (individual and institutional) necessary to carry out the proposed research is invited to work with their organization to develop an application for support. Non-US institutions invited to submit a Full Grant Proposal will be required to submit additional information at that stage.
Direct any application-related questions to:
Deniz Dalton, T1D Program Officer (ddalton@helmsleytrust.org)
Sean Sullivan, T1D Program Officer (ssullivan@helmsleytrust.org)
Grants Management (fluxxhelp@helmlseytrust.org) for technical assistance.
Applicants (Principal Investigators) will need to register with Vivli to access and explore the T1-DEXI Adult and T1-DEXIP Pediatric Data Sets