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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health

About this trial

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").

Eligibility criteria

Qualifiers

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%

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Continuous Glucose Monitoring (CGM)
  • Adaptive dietary intervention (GEM)

Treatment groups

120 Participants
are divided into 3 treatment groups

Sponsors and collaborators

NYU Langone Health

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator