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

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").

Study Overview

• Status: Not yet recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Device: Continuous Glucose Monitoring (CGM); Behavioral: Adaptive dietary intervention (GEM)

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yaguang Zheng, PhD, RN; Phone Number: 212-998-5170; Email: Yaguang.Zheng@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CGM Alone; 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); 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.
Experimental: CGM Alone, then CGM-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.	Device: 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.; Behavioral: Adaptive dietary intervention (GEM); Adapted glycemic excursion minimization (CGM-GEM).
No Intervention: Standard of Care (SC); 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Yaguang Zheng, PhD, RN, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: December 3, 2025
• First Submitted That Met QC Criteria: December 3, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Blood Chemical Analysis; Clinical Chemistry Tests; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Continuous Glucose Monitoring
• Other Study ID Numbers: 24-01868

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes