Adaptive Dietary Intervention (ADI) for Asian Americans With Type 2 Diabetes

NCT07278531 | Not Yet Recruiting

• 1 other identifier: 24-01868
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (8)

• Recruitment Rate

  Proportion of eligible participants who enroll in the trial.

  Baseline

• Retention Rate

  Proportion of recruited participants who complete the trial.

  Week 24

• Glycated Hemoglobin (A1c) Level - Baseline

  Baseline

• Glycated Hemoglobin (A1c) Level - Week 12

  Week 12

• Glycated Hemoglobin (A1c) Level - Week 24

  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.

  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.

  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.

  Week 24

Study Arms (3)

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.

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.

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.

Interventions

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.

CGM Alone; CGM Alone, then CGM-GEM

Adaptive dietary intervention (GEM) BEHAVIORAL

Adapted glycemic excursion minimization (CGM-GEM).

CGM Alone, then CGM-GEM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Yaguang Zheng, PhD, RN

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaguang Zheng, PhD, RN

CONTACT

212-998-5170; Yaguang.Zheng@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 12, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Yaguang.Zheng@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.

Locations

US (1)