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

Официальное название

Adaptive Dietary Intervention (ADI) Leveraging Continuous Glucose Monitoring for Asian Americans With Type 2 Diabetes

Обзор

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").

Вмешательства

• Устройство Continuous 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.
• Поведенческое Adaptive dietary intervention (GEM)
  Adapted glycemic excursion minimization (CGM-GEM).

Первичные конечные точки

• Recruitment Rate [Срок оценки: Baseline]
• Retention Rate [Срок оценки: Week 24]
• Glycated Hemoglobin (A1c) Level - Baseline [Срок оценки: Baseline]
• Glycated Hemoglobin (A1c) Level - Week 12 [Срок оценки: Week 12]
• Glycated Hemoglobin (A1c) Level - Week 24 [Срок оценки: Week 24]
• Time in Range (TIR) - Baseline [Срок оценки: Baseline]
• Time in Range (TIR) - Week 12 [Срок оценки: Week 12]
• Time in Range (TIR) - Week 24 [Срок оценки: Week 24]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• NYU Langone Health — New York

Идентификаторы

NCT: NCT07278531 · 24-01868

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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