Type 2 Diabetes
Conditions
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").
Interventions
DEVICEContinuous Glucose Monitoring (CGM)
Participants will receive a walk-through for CGM use with the research staff, including insertion and initiation of CGM, alarm parameter settings, data sharing via LibreView, checking and reviewing CGM glucose values and trends via Libre app or CGM reader, and the relationship between food intake and CGM results.
BEHAVIORALAdaptive dietary intervention (GEM)
Adapted glycemic excursion minimization (CGM-GEM).
Sponsors
NYU Langone Health
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | Baseline | Proportion of eligible participants who enroll in the trial. |
| Retention Rate | Week 24 | Proportion of recruited participants who complete the trial. |
| Glycated Hemoglobin (A1c) Level - Baseline | Baseline | — |
| Glycated Hemoglobin (A1c) Level - Week 12 | Week 12 | — |
| Glycated Hemoglobin (A1c) Level - Week 24 | Week 24 | — |
| Time in Range (TIR) - Baseline | 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 | 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 | Week 24 | "Time in range" (TIR) refers to the percentage of time a participant spends with their blood glucose levels within the target range. |
Countries
United States
Contacts
CONTACTYaguang Zheng, PhD, RN
PRINCIPAL_INVESTIGATORYaguang Zheng, PhD, RN
NYU Langone Health
Outcome results
None listed