Adaptive Dietary Intervention (ADI) for Asian Americans With Type 2 Diabetes
Adaptive Dietary Intervention (ADI) Leveraging Continuous Glucose Monitoring for Asian Americans With Type 2 Diabetes
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 24 weeks
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This 24-week study tests a food and blood sugar tracking program against usual care for Chinese and Vietnamese American adults with type 2 diabetes. The program starts with a sensor that tracks blood sugar, then adds food guidance in the person's language and culture if blood sugar does not improve enough. Researchers will check how well the program works and whether people find it easy to use and acceptable.
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").
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 18 or older and living independently in the community.
- Have type 2 diabetes.
- Have an A1C above 7.0%. This blood test shows average blood sugar over the past few months.
- Identify as a first- or second-generation Chinese or Vietnamese immigrant.
- Can communicate in English, Chinese, or Vietnamese. The study focuses on Mandarin, Cantonese, or English for Chinese Americans.
- Have a smartphone, iPad, tablet, or Apple Watch.
Who can't join
- Take medicines such as insulin or sulfonylureas that can cause low blood sugar and need close checks or dose changes.
- Have taken medicine that makes weight loss harder, such as prednisone, in the past 3 months; or take mental health medicines that raise blood sugar.
- Are pregnant, breastfeeding, or planning pregnancy in the next 6 months.
- Have serious physical or mental health problems, such as severe nerve damage, heart or lung disease, osteoarthritis, stroke, schizophrenia, bipolar disorder, severe depression, or active substance abuse.
- Have a condition that limits your diet, such as severely slowed stomach emptying, ulcers, or food allergies; or have greatly reduced kidney function (eGFR below 45).
- Are being treated for cancer.
- Have used or currently use a continuous blood sugar sensor, including Dexcom or FreeStyle Libre, and plan to keep using it over the next 6 months.
- Are in another study testing a treatment or program for type 2 diabetes.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.
Study sites (1)
NY
- NYU Langone Health · New York, NY 10016More trials in New York