Research & Projects

Clinical Care | Health Information Systems | Medical Device Development and Regulation | Global Health

Clinical Care

Rising T1DE Alliance - Project Sail

The Rising T1DE Alliance (RTA) is a collaborative network dedicated to transforming type 1 diabetes care through data-driven, patient-centered approaches. With support from the Helmsley Charitable Trust, RTA has developed innovative tools like the Diabetes Data Dock (D-Data Dock), a cloud-based platform integrating EHR, self-management device data, and patient-reported outcomes. In 2024, RTA expanded its focus to disseminating its technologies and methodologies across the diabetes ecosystem. Key priorities include integrating diabetes data into EHRs, enhancing predictive models, packaging D-Data Dock for broader adoption, and fostering a community of innovators in diabetes care. RTA envisions a future where diabetes management is proactive, technology-driven, and seamlessly integrated into personalized care delivery.

FoodSpace

FoodSpace, a National Institute of Allergy and Infectious Diseases (NIAID) initiative, will be a single unified hub or repository of food allergy resources and data. Think of it as a forum that includes food allergy resources and data that will be shared with the wider scientific community. The development of FoodSpace is a network-wide CoFAR study, led by NU-CoFAR Clinical Research Center at Northwestern University (PI: Dr. Ruchi Gupta and Dr. Juan Espinoza). CoFAR or the Consortium for Food Allergy Research was established in 2005 to support clinical research on food allergy and comprises one Leadership Center and ten Clinical Research Centers).

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Health Information Systems

Diabetes Research Hub

The DRH is a comprehensive data ecosystem designed to accelerate breakthroughs in diabetes research. We empower researchers by unlocking the potential of data trapped in proprietary medical devices and health systems. By creating a secure and user-friendly platform for data collection, analysis, and collaboration, the DRH fuels next-generation research using AI and ML to develop personalized and effective solutions for diabetes.

Integration of Continuous Glucose Monitoring Data into the Electronic Health Record (iCoDE)

The Integration of Continuous Glucose Monitoring Data into the Electronic Health Record (iCoDE) Project is a consortium whose purpose is to facilitate efficient uploading and integration of diabetes device data into the Electronic Health Record (EHR). The two goals of the iCoDE project are to 1) develop technical specifications to integrate CGM data into the EHR and 2) develop workflows and guidelines to facilitate data integration efforts.

Medical Device Development and Regulation

Consortium for Technology & Innovation in Pediatrics

The Consortium for Technology & Innovation in Pediatrics (CTIP) is a pediatric medical device accelerator based at Ann & Robert H. Lurie Children’s Hospital of Chicago and Children's Hospital Los Angeles. Established in 2011 and first funded by the U.S. Food and Drug Administration’s Pediatric Device Consortia (PDC) grant program in 2013, CTIP promotes the commercialization and clinical use of pediatric medical device technology. CTIP has since received PDC awards in 2018 and again in 2023 to continue research and development of MedTech for children (Grant Number: P50FD007963, PI: Espinoza).

To achieve our mission of advancing pediatric medical devices, CTIP supports and promotes high quality research related to medical device development, regulatory science, data integration, programmatic innovation, HealthTech finance, health equity, and diversity, equity and inclusion in HealthTech.

Pediatric Pandemic Network (PPN)

This project, led by Children’s National Hospital and Lurie Children’s, aims to enhance pediatric emergency preparedness by addressing regulatory science gaps in medical device development. In collaboration with FDA’s Office of Science and Engineering Laboratories (OSEL) and the Blue Knight Program, the initiative will prioritize unmet needs related to pediatric medical devices and Software as a Medical Device (SaMD), including AI-driven solutions. Key deliverables include white papers on countermeasure priorities, pediatric AI algorithm analysis, and a risk assessment model for rapid software deployment in emergencies. The project will also assess the need for a national pediatric medical device stockpile and launch a competitive funding opportunity for pediatric-focused innovations. By proactively engaging in regulatory science research, this initiative seeks to improve emergency response capabilities and accelerate the safe deployment of pediatric medical technologies.

HCT Product Ethics and Regulations

This project, Community to Commercialization: Early Ethics and Engagement Action towards Dissemination of Complex Therapies, aims to develop an ethics-centered, inclusive, and anticipatory approach to guide the early clinical development, commercialization, and dissemination of pediatric human cell, tissue, and cellular and tissue-based products (HCT/P). Using bladder tissue regeneration as a model, the project will engage affected individuals, families, and marginalized communities to explore ethical, regulatory, and public acceptance challenges related to regenerative medicine. By applying the Total Product Life Cycle framework, researchers will create a commercialization roadmap informed by community perspectives and regulatory strategies to facilitate the translation of novel therapies into clinical practice. The project will also produce a generalizable framework for stakeholder engagement in ethical and regulatory considerations for future HCT/P technologies. Through collaborations with regulatory agencies and industry partners, this initiative seeks to accelerate responsible and inclusive development of pediatric regenerative therapies.