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NCT07278531
Adaptive Dietary Intervention (ADI) for Asian Americans With Type 2 Diabetes
Conditions: Type 2 Diabetes
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 120
Sponsor: NYU Langone Health
Location: NYU Langone Health New York New York
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").
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\
Source: ClinicalTrials.gov (NCT07278531). StuddyBuddy aggregates publicly available trial information.