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

NYU Langone Health

Status: Not yet enrolling

Conditions: Type 2 Diabetes

Treatments: Behavioral: Adaptive dietary intervention (GEM); Device: Continuous Glucose Monitoring (CGM)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07278531

24-01868

Details and patient eligibility

About

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").

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

CGM Alone

Experimental group

Description:

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.

Treatment:

Device: Continuous Glucose Monitoring (CGM)

CGM Alone, then CGM-GEM

Experimental group

Description:

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.

Treatment:

Device: Continuous Glucose Monitoring (CGM)

Behavioral: Adaptive dietary intervention (GEM)

Standard of Care (SC)

No Intervention group

Description:

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.