Objective
For the Research and Data component we are proposing to link registry participant CGM data and currently collected Registry data – i.e., self-reported data covering general/demographic information, socioeconomic information, general health information, diabetes management data, self-reported outcomes (e.g., related to DKA and hypo- and hyperglycemic events), and psychosocial information (such as a diabetes distress screener) – with large, longitudinal, real-world databases. The objective of the research and data component to provide real-world evidence to make significant progress in effecting change (or if applicable, confirming/underscoring current paradigms) related to the acceptance of CGM-derived metrics as suitable, sufficiently predictive clinical measurements, developing guidelines in how to most effectively leverage CGM use in T1D drug trials, and determine with a high degree of granularity how CGM use/value is distributed by contextual categories (e.g., age group) applicable to these research/advocacy areas.
Background Rationale
T1D Exchange is dedicated to improving outcomes for the entire type 1 diabetes (T1D) population through driving real-world evidence and collaborative change. Aligned with this mission, T1D Exchange is committed to helping to improve clinical outcomes and quality of life for the T1D community by using real-world evidence/data to drive novel research and quality improvement initiatives. To achieve that goal, T1D Exchange has four programs all grounded on the collection and evaluation of data: Quality Improvement and Population Health, T1D Exchange Online Community, T1D Exchange Registry, and Custom Research.
Description of Project
The proposed project involves a collaboration between T1D Exchange and JDRF to conduct a research initiative which support our organizations’ mutual mission of improving outcomes for individuals living with type 1 diabetes (T1D). The design and scope of the data and research data project will be established in a collaborative effort between T1D Exchange and JDRF.
Anticipated Outcome
The anticipated project outcome is to drive a reduction in health disparities in technology use and improved glycemic outcomes, a furthering of the missions of both organizations by unlocking insights related to the relationships between a variety of CGM-derived metrics and key T1D-related clinical outcomes and biomarkers and clinical endpoints for long-term complications of T1D.
Relevance to T1D
The proposed project involves a collaboration between T1D Exchange and JDRF to conduct an array of research initiatives which support our organizations’ mutual mission of improving outcomes for individuals living with type 1 diabetes (T1D).