Adaptive Dietary Intervention (ADI) Leveraging Continuous Glucose Monitoring for Asian Americans With Type 2 Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- NYU Langone Health
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Time in Range (TIR) - Baseline
Study Overview
Brief 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").
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
CGM Alone
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.
Intervention: Continuous Glucose Monitoring (CGM) (Device)
CGM Alone, then CGM-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.
Intervention: Continuous Glucose Monitoring (CGM) (Device)
CGM Alone, then CGM-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.
Intervention: Adaptive dietary intervention (GEM) (Behavioral)
Standard of Care (SC)
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.
Outcomes
Primary Outcomes
Time in Range (TIR) - Baseline
Time Frame: Baseline
"Time in range" (TIR) refers to the percentage of time a participant spends with their blood glucose levels within the target range.
Time in Range (TIR) - Week 24
Time Frame: Week 24
"Time in range" (TIR) refers to the percentage of time a participant spends with their blood glucose levels within the target range.
Recruitment Rate
Time Frame: Baseline
Proportion of eligible participants who enroll in the trial.
Retention Rate
Time Frame: Week 24
Proportion of recruited participants who complete the trial.
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
Recruitment Rate
Time Frame: Baseline
Proportion of eligible participants who enroll in the trial.
Retention Rate
Time Frame: Week 24
Proportion of recruited participants who complete the trial.
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) refers to the percentage of time a participant spends with their blood glucose levels within the target range.
Time in Range (TIR) - Week 12
Time Frame: Week 12
"Time in range" (TIR) refers to the percentage of time a participant spends with their blood glucose levels within the target range.
Time in Range (TIR) - Week 24
Time Frame: Week 24
"Time in range" (TIR) refers to the percentage of time a participant spends with their blood glucose levels within the target range.
Secondary Outcomes
No secondary outcomes reported