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NCT Number: NCT05899023

ED Diabetes Screening and Outpatient Care - Aim 3

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.

Recruiting

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Key information

Conditions

Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Non Insulin Dependent Diabetes Mellitus Nutritional and Metabolic Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Telehealth Bridge Visits

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.

Standard of care

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.

Primary outcomes

  1. Percent of Patients who Complete at least One In-Person Follow-up Outpatient Visit

    Time frame: Up to Month 6 Post-Diagnosis

    A follow-up outpatient visit excludes the telehealth visits assigned to the experimental group. This outcome will be tracked using phone calls and data from Healthix, a regional health information exchange.

Secondary outcomes

  1. Percent of Patients who Complete at least One Follow-Up Hemoglobin A1C (HbA1c) Test within 6 Months of Diagnosis

    Time frame: Up to Month 6 Post-Diagnosis

    Using phone follow-up and Healthix data, investigators will assess whether ED patients with newly diagnosed diabetes have a follow-up HbA1c test within 6 months of their initial diagnosis. Trend between initial and follow-up HbA1c test will be analyzed.

  2. Percent of Patients who Complete at least One Follow-Up Hemoglobin A1C (HbA1c) Test within 12 Months of Diagnosis

    Time frame: Up to Month 12 Post-Diagnosis

    Using phone follow-up and Healthix data, investigators will assess whether ED patients with newly diagnosed diabetes have a follow-up HbA1c test within 12 months of their initial diagnosis. Trend between initial and follow-up HbA1c test will be analyzed.

  3. Percent of Patients who Start on Diabetes Medications within 6 Months of Diagnosis

    Time frame: Up to Month 6 Post-Diagnosis

    Using phone follow-up and Healthix data, investigators will assess whether ED patients with newly diagnosed diabetes are started on any type of diabetes medication within 6 months of their initial diagn

Study contacts

Contact information is provided by the study sponsor or research team.

David C. Lee

CONTACT

[email protected]

212-562-6561

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

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

Registry information

Official study title

Identifying Risk Factors for Poor Glycemic Control Among Emergency Department Patients and Improving Linkage to Outpatient Care

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 12, 2023
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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