Adaptive Dietary Intervention (ADI) for Asian Americans With Type 2 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Continuous Glucose Monitoring (CGM), Adaptive dietary intervention (GEM).
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Adaptive Dietary Intervention (ADI) Leveraging Continuous Glucose Monitoring for Asian Americans With Type 2 Diabetes
Overview
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").
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).
Primary outcome measures
- Recruitment Rate [Time frame: Baseline]
- Retention Rate [Time frame: Week 24]
- 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) - Week 12 [Time frame: Week 12]
- Time in Range (TIR) - Week 24 [Time frame: Week 24]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT07278531 · 24-01868