ED Diabetes Screening and Outpatient Care

NCT ID: NCT05899023

Last Updated: 2026-01-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2028-05-31

Brief Summary

This goal of this NIH funded R01 study is to identify risk factors for not being able to follow-up for a new diagnosis of diabetes in the emergency department and improve linkage of these newly diagnosed patients to appropriate outpatient care. Its three aims will be accomplished through 1) a retrospective chart review of emergency department (ED) patients screened for diabetes, 2) a series of prospective qualitative interviews among ED patients with newly diagnosed diabetes who fail to follow-up for outpatient care, and 3) a simple randomized controlled trial to test the efficacy of telehealth bridge visits to connect ED patients with newly diagnosed diabetes to outpatient primary care.

Conditions

Diabetes Mellitus; Non Insulin Dependent Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Telehealth Bridge Visits

Patients in the experimental arm will receive post-emergency department telehealth bridge visits to connect ED patients with newly diagnosed diabetes to outpatient primary care.

Group Type: EXPERIMENTAL

Telehealth Bridge Visits

Intervention Type: OTHER

Patients will be scheduled for a telemedicine visit staffed by a family or internal medicine trained physician who will assess their understanding and answer any questions about the new diagnosis of diabetes, start initial conversations about how to improve their habits around diet and exercise, and discuss medication options for diabetes and, if appropriate, initiate treatment. At the end of the telemedicine visit, providers will attempt to address any difficulties that patients are experiencing in accessing primary care by providing an alternative contact for care or reaching out to a primary care doctor as necessary. If the patient experiences difficulties accessing a primary care provider based on their first telemedicine visit, then an additional telemedicine visit can be scheduled for the patient.

Control

Patients in the control arm will receive standard of care.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

Standard of care currently includes calls from the site's follow-up center to see if patients received their HbA1c result, understood what their result meant, had any problems accessing medications prescribed or any difficulty scheduling an outpatient follow-up visit.

Interventions

Telehealth Bridge Visits

Patients will be scheduled for a telemedicine visit staffed by a family or internal medicine trained physician who will assess their understanding and answer any questions about the new diagnosis of diabetes, start initial conversations about how to improve their habits around diet and exercise, and discuss medication options for diabetes and, if appropriate, initiate treatment. At the end of the telemedicine visit, providers will attempt to address any difficulties that patients are experiencing in accessing primary care by providing an alternative contact for care or reaching out to a primary care doctor as necessary. If the patient experiences difficulties accessing a primary care provider based on their first telemedicine visit, then an additional telemedicine visit can be scheduled for the patient.

Intervention Type: OTHER

Standard of Care

Standard of care currently includes calls from the site's follow-up center to see if patients received their HbA1c result, understood what their result meant, had any problems accessing medications prescribed or any difficulty scheduling an outpatient follow-up visit.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Emergency patient receiving lab tests with an initial HbA1c test result of ≥ 6.5%
• Residential address in New York City or Long Island
• Primary language is English or Spanish
• Able to provide informed consent

Exclusion Criteria

• No prior history of diabetes
• No medical condition that would result in a spurious HbA1c test (e.g., sickle cell, recent blood loss)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David C. Lee

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

David C. Lee

Role: CONTACT

David.Lee@nyulangone.org

212-562-6561

Other Identifiers

23-00571

Identifier Type: -

Identifier Source: org_study_id