Recruiting

Telehealth Visits

Sponsor:

NYU Langone Health

Code:

NCT05899023

Conditions

Diabetes Mellitus

Non Insulin Dependent Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 20 - 70

Healthy Volunteers: Not accepted

Interventions

Telehealth Bridge Visits

Standard of Care

Study Details

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 ID

NCT05899023

Start date

Dec 1, 2025

Status verified date

May, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 70

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: Control

Patients in the control arm will receive standard of care.

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.

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.

Primary outcome measure

  • Percent of Patients who Complete at least One In-Person Follow-up Outpatient Visit [ Time Frame: Up to Month 6 Post-Diagnosis ]

Central Contacts and Locations

Central contacts

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

May 19, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-05-19.