An interventional study of Continuous Glucose Monitoring (CGM) and Adaptive dietary intervention (GEM) in Type 2 Diabetes, sponsored by NYU Langone Health. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Supportive care
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").
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's planned enrollment of 120 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Continuous Glucose Monitoring (CGM)
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.
Device: Continuous Glucose Monitoring (CGM) · Behavioral: Adaptive dietary intervention (GEM)
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.
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.
Adapted glycemic excursion minimization (CGM-GEM).
Recruitment Rate
Proportion of eligible participants who enroll in the trial.
Time frame: Baseline
Retention Rate
Proportion of recruited participants who complete the trial.
Time frame: Week 24
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 in range" (TIR) refers to the percentage of time a participant spends with their blood glucose levels within the target range.
Time frame: Baseline
Time in Range (TIR) - 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 frame: Week 12
Time in Range (TIR) - Week 24
"Time in range" (TIR) refers to the percentage of time a participant spends with their blood glucose levels within the target range.
Time frame: Week 24
Plan to share: Yes — The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 3 months to 5 years after publication, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Yaguang.Zheng@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements. The informed consent form, clinical study report and analytic code will also be shared.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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