Type 2 DiabetesNCT07278531
Adaptive Dietary Intervention (ADI) for Asian Americans With Type 2 Diabetes
A study testing Continuous Glucose Monitoring (CGM) and Adaptive dietary intervention (GEM) in people with Type 2 Diabetes, run by NYU Langone Health at 1 site in United States.
Trial summary
The investigators will examine the feasibility, acceptability, and effect of an adaptive dietary intervention over 24 weeks (12-week intervention, 12-week follow-up) among Asian Americans with Type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Continuous Glucose Monitoring (CGM) and Adaptive dietary intervention (GEM)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2027to 31 Aug 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible participants (N=120; 60 Chinese Americans and 60 Vietnamese Americans)
- Community-dwelling adults aged ≥ 18 with independent living;
- Diagnosed with T2D;
- Hb1Ac>7.0%
- Self-identified as first- or second-generation Chinese or Vietnamese immigrants;
- Able to communicate in English, Chinese, or Vietnamese. We will focus on Mandarin-, Cantonese- or English-speaking Chinese Americans because the two best-known and most-spoken variants of Chinese are Mandarin and Cantonese, who use the same writing system;
- Have a smartphone, iPad, tablet, or Apple watch
Who cannot join
- Taking hypoglycemia agents (e.g., insulin and sulfonylureas) with the major side effect of hypoglycemia that need close monitoring the occurrence of hypoglycemia to adjust/reduce medications to avoid future hypoglycemia.
- Taking medications that impede weight loss (e.g., prednisone) within the last 3 months.
- Currently pregnant, breastfeeding, or contemplating pregnancy within the next 6 months.
- Have serious physical complications (e.g., severe neuropathy cardiovascular disease, COPD/emphysema, osteoarthritis, or stroke) or mental disease (e.g., schizophrenia, bipolar disorder, manic depressive illness, severe depression, or active substance abuse).
- Have conditions that restrict diet, such as severe gastroparesis, ulcers, or food allergies. These conditions may need special dietary intervention.
- Undergoing treatment for cancer, as cancer treatment may impact the outcome of glucose changes.
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- Have marked renal impairment (eGRF<45; CKD-3b), as renal impairment may needs special dietary intervention and they also may impact glucose changes.
- Are taking psychotropic medications that raise blood glucose (e.g., atypical antipsychotics).
- Are prior or current CGM users including both Dexcom and FreeStyle Libre and plan to continuously use these CGMs in the next 6 months.
- Are participating in another T2D intervention study.
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: Adaptive Dietary Intervention (ADI) Leveraging Continuous Glucose Monitoring for Asian Americans With Type 2 Diabetes
The investigators will examine the feasibility, acceptability, and effect of an adaptive dietary intervention over 24 weeks (12-week intervention, 12-week follow-up) among Asian Americans with Type 2 diabetes. Participants (N=120; 60 Chinese Americans and 60 Vietnamese Americans) will be 2:1 randomized to one of two arms: adaptive dietary intervention or standard of care (SC). The intervention will begin with continued glucose monitoring (CGM) use only during weeks 0-4. At week 4, participants who achieve the glycemic control goal (at least an 8% increase in time in range [TIR] from baseline) will continue with the CGM alone during weeks 4-12 ("CGM Alone"); otherwise, culturally and linguistically adapted glucose excursion minimization (GEM) will be augmented with CGM ("CGM-GEM").
- Conditions
- Type 2 Diabetes
- Being tested
- Continuous Glucose Monitoring (CGM), Adaptive dietary intervention (GEM)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose Monitoring (CGM)Device
Participants will receive a walk-through for CGM use with the research staff, including insertion and initiation of CGM, alarm parameter settings, data sharing via LibreView, checking and reviewing CGM glucose values and trends via Libre app or CGM reader, and the relationship between food intake and CGM results.
Adaptive dietary intervention (GEM)Behavioural
Adapted glycemic excursion minimization (CGM-GEM).
| Study group | Role | What they receive |
|---|---|---|
| CGM Alone | Experimental | CGM only for weeks 1-4, continue with CGM only for weeks 4-12; this arm includes individuals who achieved the glycemic control goal at week 4. Receives: Device: Continuous Glucose Monitoring (CGM) |
| CGM Alone, then CGM-GEM | Experimental | CGM only for weeks 1-4; then CGM augmented with CEM for weeks 4-12; this arm includes individuals who did NOT achieve the glycemic control goal at week 4. Receives: Device: Continuous Glucose Monitoring (CGM); Behavioral: Adaptive dietary intervention (GEM) |
| Standard of Care (SC) | No intervention | Usual diabetes care. Current standard of care will be followed, including regular appointments (2-4 times/year) with A1c monitoring, medication titration, and screening for diabetes complications. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Proportion of eligible participants who enroll in the trial.
Measured: Baseline
Retention Rate
Proportion of recruited participants who complete the trial.
Measured: Week 24
Glycated Hemoglobin (A1c) Level - Baseline
Measured: Baseline
Glycated Hemoglobin (A1c) Level - Week 12
Measured: Week 12
Glycated Hemoglobin (A1c) Level - Week 24
Measured: Week 24
Time in Range (TIR) - Baseline
"Time in range" (TIR) refers to the percentage of time a participant spends with their blood glucose levels within the target range.
Measured: Baseline
Time in Range (TIR) - Week 12
"Time in range" (TIR) refers to the percentage of time a participant spends with their blood glucose levels within the target range.
Measured: Week 12
Time in Range (TIR) - Week 24
"Time in range" (TIR) refers to the percentage of time a participant spends with their blood glucose levels within the target range.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study startFeb 2027 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yaguang Zheng, PhD, RN, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278531
- Sponsor's protocol ID
- 24-01868
- Status last verified
- Aug 2026
- First submitted
- 3 Dec 2025
- Last updated
- 13 Aug 2026
- 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 3 months to 5 years after publication, 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: Yaguang.Zheng@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. The informed consent form, clinical study report and analytic code will also be shared.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Dietary Intervention (ADI) Leveraging Continuous Glucose Monitoring for Asian Americans With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07278531
- Acronym / sponsor ID
- 24-01868
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Feb 2027 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 12 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 investigators will examine the feasibility, acceptability, and effect of an adaptive dietary intervention over 24 weeks (12-week intervention, 12-week follow-up) among Asian Americans with Type 2 diabetes. Participants (N=120; 60 Chinese Americans and 60 Vietnamese Americans) will be 2:1 randomized to one of two arms: adaptive dietary intervention or standard of care (SC). The intervention will begin with continued glucose monitoring (CGM) use only during weeks 0-4. At week 4, participants who achieve the glycemic control goal (at least an 8% increase in time in range [TIR] from baseline) will continue with the CGM alone during weeks 4-12 ("CGM Alone"); otherwise, culturally and linguistically adapted glucose excursion minimization (GEM) will be augmented with CGM ("CGM-GEM").
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CGM Alone | Experimental | Device: Continuous Glucose Monitoring (CGM)CGM only for weeks 1-4, continue with CGM only for weeks 4-12; this arm includes individuals who achieved the glycemic control goal at week 4. |
| CGM Alone, then CGM-GEM | Experimental | Device: Continuous Glucose Monitoring (CGM), Behavioral: Adaptive dietary intervention (GEM)CGM only for weeks 1-4; then CGM augmented with CEM for weeks 4-12; this arm includes individuals who did NOT achieve the glycemic control goal at week 4. |
| Standard of Care (SC) | No intervention | –Usual diabetes care. Current standard of care will be followed, including regular appointments (2-4 times/year) with A1c monitoring, medication titration, and screening for diabetes complications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Eligible participants (N=120; 60 Chinese Americans and 60 Vietnamese Americans)
- Community-dwelling adults aged ≥ 18 with independent living;
- Diagnosed with T2D;
- Hb1Ac>7.0%
- Self-identified as first- or second-generation Chinese or Vietnamese immigrants;
Key exclusion criteria (10 listed)
- Taking hypoglycemia agents (e.g., insulin and sulfonylureas) with the major side effect of hypoglycemia that need close monitoring the occurrence of hypoglycemia to adjust/reduce medications to avoid future hypoglycemia.
- Taking medications that impede weight loss (e.g., prednisone) within the last 3 months.
- Currently pregnant, breastfeeding, or contemplating pregnancy within the next 6 months.
- Have serious physical complications (e.g., severe neuropathy cardiovascular disease, COPD/emphysema, osteoarthritis, or stroke) or mental disease (e.g., schizophrenia, bipolar disorder, manic depressive illness, severe depression, or active substance abuse).
- Have conditions that restrict diet, such as severe gastroparesis, ulcers, or food allergies. These conditions may need special dietary intervention.
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 |
|---|---|---|
| Continuous Glucose Monitoring (CGM)Participants will receive a walk-through for CGM use with the research staff, including insertion and initiation of CGM, alarm parameter settings, data sharing via LibreView, checking and reviewing CGM glucose values and trends via Libre app or CGM reader, and the relationship between food intake and CGM results. | Device | CGM Alone, CGM Alone, then CGM-GEM |
| Adaptive dietary intervention (GEM)Adapted glycemic excursion minimization (CGM-GEM). | Behavioural | CGM Alone, then CGM-GEM |
Primary outcome
Recruitment Rate
Time frame: Baseline
Proportion of eligible participants who enroll in the trial.
Retention Rate
Time frame: Week 24
Proportion of recruited participants who complete the trial.
Glycated Hemoglobin (A1c) Level - Baseline
Time frame: Baseline
Glycated Hemoglobin (A1c) Level - Week 12
Time frame: Week 12
Glycated Hemoglobin (A1c) Level - Week 24
Time frame: Week 24
Time in Range (TIR) - Baseline
Time frame: Baseline
"Time in range" (TIR) refers to the percentage of time a participant spends with their blood glucose levels within the target range.
Time in Range (TIR) - Week 12
Time frame: Week 12
"Time in range" (TIR) refers to the percentage of time a participant spends with their blood glucose levels within the target range.
Time in Range (TIR) - Week 24
Time frame: Week 24
"Time in range" (TIR) refers to the percentage of time a participant spends with their blood glucose levels within the target range.
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 13 Aug 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 3 months to 5 years after publication, 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: Yaguang.Zheng@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. The informed consent form, clinical study report and analytic code will also be shared.
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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.
Yaguang Zheng, PhD, RN 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 Continuous Glucose Monitoring (CGM) and Adaptive dietary intervention (GEM) in people with Type 2 Diabetes, 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 10 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 13 Aug 2026. 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 Yaguang Zheng, PhD, RN (212-998-5170, Yaguang.Zheng@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: Baseline). The study lists 8 primary outcomes in all. 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 13 Aug 2026.