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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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").
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGM Alone | Experimental | 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. |
|
| CGM Alone, then CGM-GEM | Experimental | 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. |
|
| Standard of Care (SC) | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitoring (CGM) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate | Proportion of eligible participants who enroll in the trial. | Baseline |
| Retention Rate | Proportion of recruited participants who complete the trial. | Week 24 |
| 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 | "Time in range" (TIR) refers to the percentage of time a participant spends with their blood glucose levels within the target range. | 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. | 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. | Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yaguang Zheng, PhD, RN | Contact | 212-998-5170 | Yaguang.Zheng@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Yaguang Zheng, PhD, RN | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
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.
Beginning 3 months and ending 5 years following article publication.
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Yaguang.Zheng@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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|
| Adaptive dietary intervention (GEM) | Behavioral | Adapted glycemic excursion minimization (CGM-GEM). |
|
| D004700 | Endocrine System Diseases |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |