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NCT Number: NCT07278531

Adaptive Dietary Intervention (ADI) 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").

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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)

Behavioral

Adapted glycemic excursion minimization (CGM-GEM).

Primary outcomes

  1. Recruitment Rate

    Time frame: Baseline

    Proportion of eligible participants who enroll in the trial.

  2. Retention Rate

    Time frame: Week 24

    Proportion of recruited participants who complete the trial.

  3. Glycated Hemoglobin (A1c) Level - Baseline

    Time frame: Baseline

  4. Glycated Hemoglobin (A1c) Level - Week 12

    Time frame: Week 12

  5. Glycated Hemoglobin (A1c) Level - Week 24

    Time frame: Week 24

  6. 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.

  7. 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.

  8. 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.

Study contacts

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

Yaguang Zheng, PhD, RN

CONTACT

[email protected]

212-998-5170

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Adaptive Dietary Intervention (ADI) Leveraging Continuous Glucose Monitoring for Asian Americans With Type 2 Diabetes

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 12, 2025
Registry last updated
Dec 12, 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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