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

NCT07278531 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-12-12

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

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

    collaborator NIH

  • NYU Langone Health

    lead OTHER

Principal Investigators

  • Yaguang Zheng, PhD, RN · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2028-08-31
Completion
2028-08-31

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07278531 on ClinicalTrials.gov