Recruiting

Observational Study

Sponsor:

NYU Langone Health

Code:

NCT07296211

Conditions

Type2 Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

CHW-enabled CCL

Mobile health (mHealth) diabetes self-management education and support (DSMES) videos

Study Details

Brief summary:

The purpose of this study is to evaluate a multi-level approach to improve diabetes control via access to social service supports and online, culturally-tailored diabetes self-management education and support (DSMES) videos among a community of primarily Chinese and Latino/a immigrants. The study aims to assess patient uptake, provider adoption, and INSPIRE program acceptability, appropriateness, feasibility, fidelity, penetration/reach, and maintenance.

Conditions

Type2 Diabetes Mellitus

Study ID

NCT07296211

Start date

Aug 14, 2026

Status verified date

Nov, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

To be eligible to participate in this study, the patient participant must meet all the following criteria:

1. ≥18 years old and ≤ 70 years old
2. Self-identify their primary language as English, Mandarin, Cantonese, or Spanish
3. Diagnosed with T2DM
4. Has their most recent HbA1c ≥8% or have a new diagnosis of T2DM within the past 6 months

For patient participants randomized to the mHealth cohort, they must meet the below inclusion criteria

1\. Willing to receive text messages with brief videos regarding T2DM management

Exclusion Criteria:

1. Unable or unwilling to provide informed consent
2. Unable to participate meaningfully in the intervention (e.g. uncorrected sight and hearing impairment)
3. Is currently pregnant (Pregnant women will be excluded from this study because they may have special dietary restrictions that are not covered by our DSMES videos for the general population with T2DM.)

Study Design

Enrollment

480 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Patients in a CHW-enabled clinic that receive mobile health (mHealth) videos

For the first 6 months participants will receive CHW-enabled services from their clinic. Over the next 6 months participants will receive 24 culturally tailored diabetes education videos via text message.

experimental: Patients in a CHW-enabled clinic that do not receive mHealth videos

For the first 6 months participants will receive CHW-enabled services from their clinic. Over the next 6 months participants will continue to receive standard of care (SOC).

no intervention: Patients in a standard clinic that do not receive mHealth videos

For 12 months participants will be followed as they receive SOC from their clinic.

Interventions

CHW-enabled CCL

The FHCs has access to the CHW-enabled CCL. With this intervention, participants will be screened for social determinants of health (SDoH) and be referred to care and social services that address any identified needs.

Mobile health (mHealth) diabetes self-management education and support (DSMES) videos

Participants will receive 24 culturally tailored DSMES videos through text message.

Primary outcome measure

  • Change in HbA1c levels [ Time Frame: Baseline, Month 6 ]

Central Contacts and Locations

Central contacts

Brita Roy

347-377-3157Brita.Roy@nyulangone.org

Julia Duch

201-424-3571Julia.Duch@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Nov 13, 2026

Last verified

Nov, 2026

Keywords

  • T2DM
  • Diabetes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-14. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-11-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.