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NCT Number: NCT07296211

INcreasing the Uptake of DSMES Program and Addressing Social Needs in Low-Income VulneRablE Immigrants

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

About this study

In stage 1, the 8 family health center (FHC) clinics will be randomized 1:1 into Experimental Cohort A, which will receive the Community Health Worker (CHW)-enabled community-clinic linkage model (CCL) or Control Cohort B, with FHCs that will not receive the CHW-enabled CCL. Then, in stage 2, patients in clinics that received the CHW-enabled CCL will be randomized in a 1:1 ratio to Arm A who will receive text-based mhealth diabetes education videos or Arm B who will not receive mhealth.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

  • ≥18 years old and ≤ 70 years old
  • Self-identify their primary language as English, Mandarin, Cantonese, or Spanish
  • Diagnosed with T2DM
  • 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

  • Willing to receive text messages with brief videos regarding T2DM management

Exclusion criteria

  • Unable or unwilling to provide informed consent
  • Unable to participate meaningfully in the intervention (e.g. uncorrected sight and hearing impairment)
  • 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.)

Treatment and study plan

CHW-enabled CCL

Behavioral

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

Behavioral

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

Primary outcomes

  1. Change in HbA1c levels

    Time frame: Baseline, Month 6

Secondary outcomes

  1. Level of satisfaction with community-clinic linkage (CCL) and mHealth

    Time frame: Month 12

    Participants are asked to rate satisfaction on a scale of 1 (not satisfied at all) to 10 (very satisfied).

  2. Percentage of patients accepting Community Health Worker (CHW) support

    Time frame: Month 12

  3. Percentage of patients accepting mHealth

    Time frame: Month 12

  4. Percent completion of social service referrals

    Time frame: Month 6

  5. Percent mhealth videos watched

    Time frame: Month 12

Study contacts

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

Brita Roy

CONTACT

[email protected]

347-377-3157

Julia Duch

CONTACT

[email protected]

201-424-3571

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Acronym: INSPIRE

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Dec 22, 2025
Registry last updated
Dec 22, 2025

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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