Diabetes Mellitus, Type 2NCT04949568
Self-Management and Glycemic Control in Adult Haitian Immigrants With Type 2 Diabetes
A study testing Diabetes Self-Management Behaviors in people with Diabetes Mellitus, Type 2 and Patient Engagement, run by New York University at 1 site in United States.
Trial summary
The objective of the study is to conduct a pilot randomized study to test feasibility and preliminary efficacy of the developed diabetes self-management education program with 40 adult Haitian immigrants. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Patient Engagement, Patient Education
- What is being tested?
- Diabetes Self-Management Behaviors
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-described Haitian immigrant aged 21 and older
- Known diagnosis of type 2 diabetes for at least one year
- Have lived in the US for at least one year
- Have an HbA1c of 7.5%
- Willing and able to participate in an individual interview
Who cannot join
- Having a diagnosis of type 1 diabetes
- Unable to comprehend, consent and or fully participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Self-Management and Glycemic Control in Adult Haitian Immigrants With Type 2 Diabetes: A Pilot Randomized Study
The objective of the study is to conduct a pilot randomized study to test feasibility and preliminary efficacy of the developed diabetes self-management education program with 40 adult Haitian immigrants.
Read the detailed description
This is a two-arm randomized trial. Participants will be randomized to the culturally tailored Diabetes Self-Management Education Program or standard care condition in a 1:1 allocation. All participants will receive standard type 2 diabetes care at the enrolled clinic and remain under their providers' care for the duration of the study. The culturally tailored Diabetes Education Program involves the following: 1) an initial 45-minute face-to-face consultation; and 2) six 2-hour weekly interactive educational sessions in a format to be determined (TBD) by Aim 1 (e.g., in-person, video/telephone conference call).
- Being tested
- Diabetes Self-Management Behaviors
- Keywords
- Immigrant Health, Diabetes Mellitus, Type 2, Metabolic Diseases, Self-Management Behaviors, Haitian Americans
- Medical subject headings
- Diabetes Mellitus, Type 2, Patient Participation, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Self-Management BehaviorsBehavioural
The intervention is to be delivered by an interventionist.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Self-Management Behaviors | Experimental | Self-Management Education Program The culturally tailored Diabetes Self-Management Education Program involves the following: 1) an initial 45-minute face-to-face private consultation collaboratively determining goals; followed by 2) six 2-hour weekly educational interactive sessions in a format TBD by aim 1. We will deliver culturally targeted written materials and presentations in these sessions. Participants will be asked to practice self-management behaviors concurrently and for four additional weeks. Receives: Behavioral: Diabetes Self-Management Behaviors |
| Usual Type 2 Diabetes Care | No intervention | The usual care arm will receive the clinic's standard type 2 diabetes care and remain under their providers' care for the duration of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summary of Diabetes of Self-Care Activities Scale (11- item)
Change in diabetes self-management behaviors (0-7, higher scores indicate improvement)
Measured: (T0) baseline through (T3) 90 days post-intervention
Stanford Diabetes Self-Efficacy Scale (8- item)
Change in general self-efficacy 1-10, higher scores indicate improvement)
Measured: (T0) baseline through (T3) 90 days post-intervention
Wrist-worn actigraphy (ActiGraph) to be worn while awake
Change in physical activity (Frequent physical activity indicates improvement)
Measured: (T0) baseline through (T3) 90 days post-intervention
Glucose Variability data from continuous glucose monitor (CGM) will be downloaded directly from participants provided (blinded) FreeStyle Libre Pro
Time in range and glucose variability (More time in range and less glucose variability indicates improvement)
Measured: (T0) baseline through (T3) 90 days post-intervention
Secondary outcomes (1)
Diabetes Distress Scale (DDS) (17-item), using Numerical Rating Scale: 0-6
Change in diabetes distress ( 0-6, lower scores indicates improvement)
Measured: (T0) baseline through (T3) 90 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start12 Aug 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by New York UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Behavioral: Diabetes Self-management behaviors
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cherlie Magny-Normilus, PhD, FNP-BC, FAAN, Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949568
- Sponsor's protocol ID
- 2024-9103
- Status last verified
- Oct 2024
- First submitted
- 25 Jun 2021
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Magny-Normilus C, Whittemore R, Wexler DJ, Schnipper JL, Nunez-Smith M, Fu MR. Barriers to Type 2 Diabetes Management Among Older Adult Haitian Immigrants. Sci Diabetes Self Manag Care. 2021 Oct;47(5):382-390. doi: 10.1177/26350106211040435.
PubMed 34610761
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Management and Glycemic Control in Adult Haitian Immigrants With Type 2 Diabetes: A Pilot Randomized Study
- ClinicalTrials.gov ID
- NCT04949568
- Acronym / sponsor ID
- 2024-9103
- Keywords
- Immigrant Health, Diabetes Mellitus, Type 2, Metabolic Diseases, Self-Management Behaviors, Haitian Americans
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Study start
- 12 Aug 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Jul 2021 (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 objective of the study is to conduct a pilot randomized study to test feasibility and preliminary efficacy of the developed diabetes self-management education program with 40 adult Haitian immigrants.
Detailed description
This is a two-arm randomized trial. Participants will be randomized to the culturally tailored Diabetes Self-Management Education Program or standard care condition in a 1:1 allocation. All participants will receive standard type 2 diabetes care at the enrolled clinic and remain under their providers' care for the duration of the study. The culturally tailored Diabetes Education Program involves the following: 1) an initial 45-minute face-to-face consultation; and 2) six 2-hour weekly interactive educational sessions in a format to be determined (TBD) by Aim 1 (e.g., in-person, video/telephone conference call).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Behavioral: Diabetes Self-management behaviors
| Arm | Type | Receives |
|---|---|---|
| Diabetes Self-Management Behaviors | Experimental | Behavioral: Diabetes Self-Management BehaviorsSelf-Management Education Program The culturally tailored Diabetes Self-Management Education Program involves the following: 1) an initial 45-minute face-to-face private consultation collaboratively determining goals; followed by 2) six 2-hour weekly educational interactive sessions in a format TBD by aim 1. We will deliver culturally targeted written materials and presentations in these sessions. Participants will be asked to practice self-management behaviors concurrently and for four additional weeks. |
| Usual Type 2 Diabetes Care | No intervention | –The usual care arm will receive the clinic's standard type 2 diabetes care and remain under their providers' care for the duration of the study. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Self-described Haitian immigrant aged 21 and older
- Known diagnosis of type 2 diabetes for at least one year
- Have lived in the US for at least one year
- Have an HbA1c of 7.5%
- Willing and able to participate in an individual interview
Key exclusion criteria (2 listed)
- Having a diagnosis of type 1 diabetes
- Unable to comprehend, consent and or fully participate in the study
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 |
|---|---|---|
| Diabetes Self-Management BehaviorsThe intervention is to be delivered by an interventionist. | Behavioural | Diabetes Self-Management Behaviors |
Primary outcome
Summary of Diabetes of Self-Care Activities Scale (11- item)
Time frame: (T0) baseline through (T3) 90 days post-intervention
Change in diabetes self-management behaviors (0-7, higher scores indicate improvement)
Stanford Diabetes Self-Efficacy Scale (8- item)
Time frame: (T0) baseline through (T3) 90 days post-intervention
Change in general self-efficacy 1-10, higher scores indicate improvement)
Wrist-worn actigraphy (ActiGraph) to be worn while awake
Time frame: (T0) baseline through (T3) 90 days post-intervention
Change in physical activity (Frequent physical activity indicates improvement)
Glucose Variability data from continuous glucose monitor (CGM) will be downloaded directly from participants provided (blinded) FreeStyle Libre Pro
Time frame: (T0) baseline through (T3) 90 days post-intervention
Time in range and glucose variability (More time in range and less glucose variability indicates improvement)
1 secondary outcome
Diabetes Distress Scale (DDS) (17-item), using Numerical Rating Scale: 0-6
Time frame: (T0) baseline through (T3) 90 days post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Background: PubMed 34610761Magny-Normilus C, Whittemore R, Wexler DJ, Schnipper JL, Nunez-Smith M, Fu MR. Barriers to Type 2 Diabetes Management Among Older Adult Haitian Immigrants. Sci Diabetes Self Manag Care. 2021 Oct;47(5):382-390. doi: 10.1177/26350106211040435.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Cherlie Magny-Normilus, PhD, FNP-BC, FAAN principal investigator
New York University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Self-Management Behaviors in people with Diabetes Mellitus, Type 2 and Patient Engagement, run by New York University 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 22 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Summary of Diabetes of Self-Care Activities Scale (11- item) (time frame: (T0) baseline through (T3) 90 days post-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04949568, which also lists 1 linked publication.
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 Jul 2025.