Adaptive Dietary Intervention for Type 2 Diabetes

Overseen By Yaguang Zheng, PhD, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Insulin, Sulfonylureas, Prednisone, Antipsychotics

Disqualifiers: Pregnancy, Cancer, Renal impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special diet plan to help Asian Americans with Type 2 diabetes manage their blood sugar levels more effectively. Researchers will divide participants into two groups: one will use a glucose monitor alone, while the other will combine the monitor with a personalized diet plan if needed. The study aims to evaluate the effectiveness and ease of following these methods. It is suitable for Chinese or Vietnamese Americans with Type 2 diabetes who are not using certain diabetes medications and own a smartphone or similar device. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance diabetes management for many.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that changing one's diet can safely and effectively manage type 2 diabetes. One study found that these changes reduced diabetes-related stress and improved participants' overall well-being. Another study demonstrated that the GEM (glycemic excursion minimization) method enhanced both emotional health and physical activity.

These dietary changes are generally safe and manageable. No major negative effects have been directly linked to GEM. Since dietary changes do not involve surgery or medication, they often carry fewer risks. However, individual differences exist, so consulting a doctor before starting any new diet plan is important to ensure its suitability. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how adaptive dietary interventions, combined with continuous glucose monitoring (CGM), might improve blood sugar control in people with type 2 diabetes. Unlike standard treatments that primarily rely on medication and regular monitoring, this approach uses a dynamic dietary plan to adjust food intake based on real-time glucose data. By potentially providing more personalized and immediate adjustments to diet, this method could lead to better and faster control of blood sugar levels, offering a promising alternative to current standard care options.

What evidence suggests that this trial's treatments could be effective for Type 2 diabetes?

Research shows that changing one's diet, such as using the GEM (Glucose Excursion Minimization) method, which participants in this trial may receive, can help manage type 2 diabetes. Studies have found that lifestyle changes can reduce the risk of developing diabetes by 25% and improve blood sugar levels. One study found that certain diet plans improved the quality of food choices for people with type 2 diabetes. Another study noted that lowering HbA1c (a measure of average blood sugar) by just 1% reduced the risk of diabetes-related deaths by 21%. These findings suggest that dietary changes may help control blood sugar and reduce health risks for people with type 2 diabetes. ^{1 6 7 8 9}

Who Is on the Research Team?

Yaguang Zheng, PhD, RN

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for Asian Americans with Type 2 diabetes, specifically targeting Chinese and Vietnamese communities. Participants should be willing to undergo a dietary intervention and use continuous glucose monitoring (CGM) devices. The study excludes individuals who don't meet the specific ethnic criteria or have conditions that could interfere with the trial.

Inclusion Criteria

Have a smartphone, iPad, tablet, or Apple watch

Eligible participants (N=120; 60 Chinese Americans and 60 Vietnamese Americans)

Hb1Ac > 7.0%

Exclusion Criteria

Currently pregnant, breastfeeding, or contemplating pregnancy within the next 6 months

Have conditions that restrict diet, such as severe gastroparesis, ulcers, or food allergies

Prior or current CGM users including both Dexcom and FreeStyle Libre and plan to continuously use these CGMs in the next 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants undergo an adaptive dietary intervention with continuous glucose monitoring (CGM) for 12 weeks. Initial 4 weeks involve CGM only, followed by either continued CGM or CGM with glucose excursion minimization (GEM) based on glycemic control.

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Adaptive Dietary Intervention (GEM)

Trial Overview The study tests an adaptive dietary intervention over a period of 24 weeks among participants with Type 2 diabetes. It involves initial CGM use, followed by either continued CGM alone or combined with a culturally adapted diet plan based on glycemic control success at week four.

How Is the Trial Designed?

Group I: CGM Alone, then CGM-GEM Experimental Treatment 2 Interventions

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.

Group II: CGM Alone Experimental Treatment 1 Intervention

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.

Group III: Standard of Care (SC) Active Control 1 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.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12329975/

Effects of 12 nutritional interventions on type 2 diabetes The LGI + LGL intervention was most effective in reducing TC (SUCRA = 88.3%), TG (SUCRA = 80.6%), and BMI (SUCRA = 99.8%), with statistically ...

2. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(22)00380-7/fulltext

The effectiveness of lifestyle interventions on type 2 ... Lifestyle interventions decreased the incidence risk ratio of type 2 diabetes by 25% (0·75 [95% CI 0·61 to 0·91]), and reduced the levels of ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34222067/

Effectiveness of an adapted diabetes nutrition education ... Conclusions: NEP had limited effects on HbA1c, targeted dietary behaviors and behavior mediators but showed positive effects on blood pressure.

4. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2021.583125/full

Effectiveness of the Beyond Good Intentions Program on ... The BGI program was significantly effective in improving dietary quality among preselected people with T2DM compared to care as usual.

5. nature.com nature.com/articles/s41387-023-00240-8

results of the T2Diet Study randomised controlled trial Each 1% reduction in HbA1c represents a risk reduction of 21% for diabetes-related deaths, 14% for heart attacks, and 37% for microvascular ...

6. nature.com nature.com/articles/s41598-024-76584-7

One-year outcomes of a digital twin intervention for type 2 ... A decrease of 1% in HbA1c levels was linked with a 37% lower risk of microvascular complications and a 21% reduction in the risk of any diabetes ...

7. drc.bmj.com drc.bmj.com/content/8/2/e001795

Glycemic excursion minimization in the management of ... Only GEM participants significantly improved diabetes empowerment, diabetes distress, depressive symptoms, steps/day, and active hours and ...

8. diabetesjournals.org diabetesjournals.org/care/article/48/12/2181/163414/Type-2-Diabetes-Remission-A-Systematic-Review-and

Type 2 Diabetes Remission: A Systematic Review and Meta ... Other significant outcomes for intervention groups compared with control groups included change in A1C, weight loss, and quality of life and ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT01777893

Effect of Diet and Physical Activity on Incidence of Type 2 ... The primary endpoint of the study is the incidence of Type-2 diabetes in the adults during 3 years (156 weeks) according to diet (high protein/low-GI versus ...