Type2 Diabetes MellitusINSPIRENCT07296211
INcreasing the Uptake of DSMES Program and Addressing Social Needs in Low-Income VulneRablE Immigrants
A study testing CHW-enabled CCL and Mobile health (mHealth) diabetes self-management education and support (DSMES) videos in people with Type2 Diabetes Mellitus, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type2 Diabetes Mellitus
- What is being tested?
- CHW-enabled CCL and Mobile health (mHealth) diabetes self-management education and support (DSMES) videos
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2026to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 1. Willing to receive text messages with brief videos regarding T2DM management
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Type2 Diabetes Mellitus
- Being tested
- CHW-enabled CCL, Mobile health (mHealth) diabetes self-management education and support (DSMES) videos
- Keywords
- T2DM, Diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHW-enabled CCLBehavioural
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) videosBehavioural
Participants will receive 24 culturally tailored DSMES videos through text message.
| Study group | Role | What they receive |
|---|---|---|
| Patients in a CHW-enabled clinic that receive mobile health (mHealth) videos | Experimental | 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. Receives: Behavioral: CHW-enabled CCL; Behavioral: Mobile health (mHealth) diabetes self-management education and support (DSMES) videos |
| Patients in a CHW-enabled clinic that do not receive mHealth videos | Experimental | 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). Receives: Behavioral: CHW-enabled CCL |
| Patients in a standard clinic that do not receive mHealth videos | No intervention | For 12 months participants will be followed as they receive SOC from their clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c levels
Measured: Baseline, Month 6
Secondary outcomes (5)
Level of satisfaction with community-clinic linkage (CCL) and mHealth
Participants are asked to rate satisfaction on a scale of 1 (not satisfied at all) to 10 (very satisfied).
Measured: Month 12
Percentage of patients accepting Community Health Worker (CHW) support
Measured: Month 12
Percentage of patients accepting mHealth
Measured: Month 12
Percent completion of social service referrals
Measured: Month 6
Percent mhealth videos watched
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadia Islam, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296211
- Sponsor's protocol ID
- 24-01080
- Other IDs
- 5U48DP006778
- Acronym
- INSPIRE
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Brita.Roy@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing the Uptake of DSMES Program and Addressing Social Needs in Low-Income Vulnerable Immigrants
- ClinicalTrials.gov ID
- NCT07296211
- Acronym / sponsor ID
- INSPIRE / 24-01080
- Conditions
- Type2 Diabetes Mellitus
- Keywords
- T2DM, Diabetes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients in a CHW-enabled clinic that receive mobile health (mHealth) videos | Experimental | Behavioral: CHW-enabled CCL, Behavioral: Mobile health (mHealth) diabetes self-management education and support (DSMES) videosFor 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. |
| Patients in a CHW-enabled clinic that do not receive mHealth videos | Experimental | Behavioral: CHW-enabled CCLFor 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). |
| Patients in a standard clinic that do not receive mHealth videos | No intervention | –For 12 months participants will be followed as they receive SOC from their clinic. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHW-enabled CCLThe 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. | Behavioural | Patients in a CHW-enabled clinic that do not receive mHealth videos, Patients in a CHW-enabled clinic that receive mobile health (mHealth) videos |
| Mobile health (mHealth) diabetes self-management education and support (DSMES) videosParticipants will receive 24 culturally tailored DSMES videos through text message. | Behavioural | Patients in a CHW-enabled clinic that receive mobile health (mHealth) videos |
Primary outcome
Change in HbA1c levels
Time frame: Baseline, Month 6
5 secondary outcomes
Level of satisfaction with community-clinic linkage (CCL) and mHealth
Time frame: Month 12
Percentage of patients accepting Community Health Worker (CHW) support
Time frame: Month 12
Percentage of patients accepting mHealth
Time frame: Month 12
Percent completion of social service referrals
Time frame: Month 6
Percent mhealth videos watched
Time frame: Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Brita.Roy@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nadia Islam, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHW-enabled CCL and Mobile health (mHealth) diabetes self-management education and support (DSMES) videos in people with Type2 Diabetes Mellitus, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brita Roy (347-377-3157, Brita.Roy@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c levels (time frame: Baseline, Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.