Adaptive Dietary Intervention (ADI) Leveraging Continuous Glucose Monitoring for Asian Americans With Type 2 Diabetes
| Registry | NCT07278531 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, supportive care |
| Enrollment | 120 (Estimated) |
| Sponsor | NYU Langone Health (Other); collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Conditions | Type 2 Diabetes |
| Interventions | Continuous Glucose Monitoring (CGM), Adaptive dietary intervention (GEM) (Device, behavioral) |
| Dates | start 2027-02-01 (estimated), primary completion 2028-08-31 (estimated), completion 2028-08-31 (estimated), first posted 2025-12-12, last updated 2026-08-13 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Type 2 Diabetes All trials of Continuous Glucose Monitoring (CGM) All trials of Adaptive dietary intervention (GEM)
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").
| Arm | Type | Interventions | Description |
|---|---|---|---|
| CGM Alone | Experimental | Device: Continuous Glucose Monitoring (CGM) | 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. |
| CGM Alone, then CGM-GEM | Experimental | Device: Continuous Glucose Monitoring (CGM); Behavioral: Adaptive dietary intervention (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. |
| Standard of Care (SC) | No intervention | 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. |
Sex: All, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| NYU Langone Health | New York, New York | United States |