Telehealth Follow-Up for Diabetes

Overseen By David C. Lee

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Sickle cell, recent blood loss

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

How is the Telehealth Bridge Visits treatment for diabetes different from other treatments?

Telehealth Bridge Visits for diabetes is unique because it uses telehealth technology to provide follow-up care remotely, allowing patients to manage their condition from home. This approach can improve diabetes outcomes by offering continuous support and monitoring, which is different from traditional in-person visits. ^{1 2 3 4 5}

What data supports the effectiveness of this treatment for diabetes?

Research shows that telehealth, including telemedicine and telephone follow-up, can help improve diabetes management by reducing blood sugar levels and cholesterol in patients, especially in underserved areas. Studies like the IDEATel and Mississippi Diabetes Telehealth Network have demonstrated significant improvements in key health measures for diabetes patients using telehealth interventions. ^{1 6 7 8 9}

Who Is on the Research Team?

David C. Lee

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for emergency department patients in New York City or Long Island who speak English or Spanish, can consent to participate, and have an initial HbA1c test result of ≥ 6.5%, indicating new diabetes. It's not for those with a history of diabetes or conditions affecting the HbA1c test.

Inclusion Criteria

Able to provide informed consent

Residential address in New York City or Long Island

Primary language is English or Spanish

Exclusion Criteria

I have never been diagnosed with diabetes.

You do not have any medical condition that could affect the accuracy of the HbA1c test, like sickle cell disease or recent significant blood loss.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Retrospective Chart Review

Retrospective chart review of emergency department patients screened for diabetes

Not specified

Qualitative Interviews

Prospective qualitative interviews among ED patients with newly diagnosed diabetes who fail to follow-up for outpatient care

Not specified

Randomized Controlled Trial

Testing the efficacy of telehealth bridge visits to connect ED patients with newly diagnosed diabetes to outpatient primary care

Up to 6 months

Follow-up

Participants are monitored for completion of at least one in-person follow-up outpatient visit

Up to 6 months post-diagnosis

What Are the Treatments Tested in This Trial?

Interventions

• Standard of Care
• Telehealth Bridge Visits

Trial Overview The study tests if telehealth bridge visits are effective in connecting patients newly diagnosed with diabetes in the ED to follow-up outpatient care, compared to standard practices. It includes chart reviews, interviews, and a randomized controlled trial component.

How Is the Trial Designed?

Group I: Telehealth Bridge Visits Experimental Treatment 1 Intervention

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 II: Control Active Control 1 Intervention

Patients in the control arm will receive standard of care.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

A randomized controlled trial involving 1,665 Medicare recipients with diabetes demonstrated that telemedicine case management significantly improved key health metrics, including hemoglobin A1c, LDL cholesterol, and blood pressure over a 5-year period.

Despite the improvements in health outcomes, the study found no significant difference in mortality rates between the telemedicine and usual care groups, suggesting that while telemedicine is effective for managing diabetes, it does not impact overall survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial comparing telemedicine case management with usual care in older, ethnically diverse, medically underserved patients with diabetes mellitus: 5 year results of the IDEATel study. Shea, S., Weinstock, RS., Teresi, JA., et al.[2022]

Project ECHO is a telementoring program that enhances the management of complex diseases like diabetes in underserved areas by allowing multiple patients to benefit from shared expertise, rather than just one-on-one specialist consultations.

The Endo ECHO program, specifically designed for patients with complex diabetes in rural New Mexico, is undergoing a 4-year evaluation to assess its impact on health outcomes, healthcare utilization, and cost-effectiveness, potentially serving as a model for similar initiatives globally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Taking Telemedicine to the Next Level in Diabetes Population Management: a Review of the Endo ECHO Model. Bouchonville, MF., Paul, MM., Billings, J., et al.[2018]

Citations

1. England pubmed.ncbi.nlm.nih.gov

A randomized trial comparing telemedicine case management with usual care in older, ethnically diverse, medically underserved patients with diabetes mellitus: 5 year results of the IDEATel study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Diabetes: follow-up support for patients with uncontrolled diabetes. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Taking Telemedicine to the Next Level in Diabetes Population Management: a Review of the Endo ECHO Model. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Mississippi Diabetes Telehealth Network: A Collaborative Approach to Chronic Care Management. [2021]

5. Ireland pubmed.ncbi.nlm.nih.gov

Telecare in a structured therapeutic education programme addressed to patients with type 1 diabetes and poor metabolic control. [2011]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Clinical audit and standardised follow up improve quality of documentation in diabetes care. [2010]

7. United States pubmed.ncbi.nlm.nih.gov

Web-based telemedicine for management of type 2 diabetes through glucose uploads: a randomized controlled trial. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Inpatient to outpatient transfer of diabetes care: perceptions of barriers to postdischarge followup in urban African American patients. [2022]

9. Ireland pubmed.ncbi.nlm.nih.gov

The effectiveness of a televisit service for people with type 1 diabetes: An observational, retrospective, single center, one year follow-up study. [2022]