255 Participants Needed

Personalized Dietary Management for Type 2 Diabetes

(DiaTeleMed Trial)

MC
MB
LH
Overseen ByLu Hu, PhD, RN
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

In a randomized trial of 255 participants with early-stage T2D, participants will be randomized to 1 of 3 groups: Standardized, Personalized, or a Usual Care Control (UCC). In the first phase, participants will be randomized with equal allocation to these 3 groups. In the second phase (current phase), the remaining participants will be randomized with equal allocation to the Standardized and UCC groups.

Do I have to stop taking my current medications for the trial?

The trial requires that participants are only on metformin for diabetes management and have not taken antibiotics, antifungals, or other specified medications in the past 3 months. If you are on other diabetic medications or certain other drugs, you may need to stop them to participate.

What data supports the effectiveness of the treatment Personalized Dietary Management for Type 2 Diabetes?

Research suggests that personalized dietary approaches, such as those using a machine-learning algorithm to predict glycemic response, can improve glycemic control in individuals with type 2 diabetes. Additionally, combining Mediterranean diets with genetic information has shown promise in achieving better glycemic control, as evidenced by a case study of a patient with type 2 diabetes.12345

Is personalized dietary management for type 2 diabetes safe for humans?

The research does not specifically address safety concerns, but personalized dietary management approaches, like the Mediterranean diet and personalized postprandial glucose response-targeting diets, are generally considered safe and focus on improving metabolic health and glycemic control.12467

How is the Personalized Dietary Management for Type 2 Diabetes treatment different from other treatments?

This treatment is unique because it combines a Mediterranean diet with personalized guidance to minimize blood sugar spikes after meals, using a gut microbiome-based algorithm and behavioral counseling. This personalized approach aims to improve blood sugar control by tailoring dietary advice to individual responses, unlike standard one-size-fits-all dietary recommendations.12458

Research Team

CJ

Collin J Popp, PhD, RD

Principal Investigator

NYU Langone Health

Eligibility Criteria

Adults aged 21-80 with early-stage Type 2 Diabetes (T2D), HbA1c<8%, on a stable diabetes regimen including metformin, able to use a smartphone and attend online sessions. Excludes those with certain chronic diseases, unable or unwilling to follow the diet plan, pregnant women, those with limited mobility or control over their diet, substance abusers, and people on specific medications.

Inclusion Criteria

Those who are willing and able to use a smart phone to self monitor their diet and to attend WebEx sessions
I have early-stage Type 2 Diabetes with HbA1c under 8%, managed with lifestyle changes and metformin for the past 3 months.
I am between 21 and 80 years old.

Exclusion Criteria

Those who are unable or unwilling to adhere to an intervention that requires dietary self-monitoring
You have limited control over what you eat, for example, if you are homeless, in a nursing home, or in jail.
I have been diagnosed with a long-term inflammatory or cancerous disease in the last 3 years.
See 12 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Randomization and Initial Intervention

Participants are randomized into Standardized, Personalized, or Usual Care Control groups and receive initial dietary counseling and education

0-3 months
1 visit (in-person) at baseline

Intervention Continuation

Participants continue with their assigned dietary intervention and receive ongoing counseling

3-6 months
1 visit (in-person) at 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 visit (in-person) at 6 months

Treatment Details

Interventions

  • Isocaloric Mediterranean Diet Advice
  • Personalized Guidance to Minimize Postprandial Glycemic Response (PPGR)
  • SCT-Based Behavioral Counseling
  • Standardized
  • Usual Care Control (UCC)
Trial OverviewThe trial is testing how effective personalized dietary guidance is at managing blood sugar after meals compared to standardized advice and usual care in people with T2D. It randomly assigns participants into three groups: Standardized Guidance Group, Personalized Guidance Group, or Usual Care Control Group.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Usual Care Control (UCC)Experimental Treatment1 Intervention
Baseline advice about the Mediterranean-style diet and attention control.
Group II: PersonalizedActive Control3 Interventions
Dietary counseling to follow a Mediterranean-style diet personalized to reduce postprandial glycemic response
Group III: StandardizedActive Control2 Interventions
One-size-fits-all dietary counseling to follow a Mediterranean-style diet

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials
623
Recruited
10,400,000+

Findings from Research

The Personal Diet Study is investigating the effectiveness of two dietary interventions for weight loss in individuals with prediabetes and type 2 diabetes: a standard low-fat diet and a personalized diet based on machine-learning predictions of glycemic response.
The study will assess changes in body weight, body composition, and resting energy expenditure over a 6-month intervention period, followed by a 6-month observation period to evaluate the maintenance of weight loss, utilizing mobile health technology for behavioral support.
The rationale and design of the personal diet study, a randomized clinical trial evaluating a personalized approach to weight loss in individuals with pre-diabetes and early-stage type 2 diabetes.Popp, CJ., St-Jules, DE., Hu, L., et al.[2022]
High-quality diets and healthy lifestyles are crucial for managing type 2 diabetes mellitus (T2DM), but there is no consensus on the ideal macronutrient proportions for those with pre-diabetes or T2DM.
Personalized dietary approaches, such as coupling Mediterranean diets with genetic information, can lead to improved glycemic control, as demonstrated by a case study of a T2DM patient who achieved rapid results with this tailored diet.
Genetically Guided Mediterranean Diet for the Personalized Nutritional Management of Type 2 Diabetes Mellitus.Gkouskou, K., Lazou, E., Skoufas, E., et al.[2021]
In a study of 136 Japanese adults with type 2 diabetes, individualized dietary advice led to a greater reduction in HbA1c levels (-1.1%) compared to conventional dietary advice (-0.7%) over 6 months, indicating its effectiveness in managing blood sugar levels.
Participants receiving individualized advice also made healthier dietary changes, such as reducing energy intake and consumption of sweets and fats, which contributed to improvements in weight and lipid profiles, although these changes were not significantly different from the conventional group.
Effects of individualized dietary advice compared with conventional dietary advice for adults with type 2 diabetes: A randomized controlled trial.Omura, Y., Murakami, K., Matoba, K., et al.[2022]

References

The rationale and design of the personal diet study, a randomized clinical trial evaluating a personalized approach to weight loss in individuals with pre-diabetes and early-stage type 2 diabetes. [2022]
Genetically Guided Mediterranean Diet for the Personalized Nutritional Management of Type 2 Diabetes Mellitus. [2021]
Effects of individualized dietary advice compared with conventional dietary advice for adults with type 2 diabetes: A randomized controlled trial. [2022]
Personalized Postprandial Glucose Response-Targeting Diet Versus Mediterranean Diet for Glycemic Control in Prediabetes. [2022]
Effects of personalized diets by prediction of glycemic responses on glycemic control and metabolic health in newly diagnosed T2DM: a randomized dietary intervention pilot trial. [2022]
Effect of a Personalized Diet to Reduce Postprandial Glycemic Response vs a Low-fat Diet on Weight Loss in Adults With Abnormal Glucose Metabolism and Obesity: A Randomized Clinical Trial. [2022]
A New Approach to Personalized Nutrition: Postprandial Glycemic Response and its Relationship to Gut Microbiota. [2023]
The Meaningful Effects of a Personalized Nutrition and Coaching Program for Type 2 Diabetes Mellitus: Two Case Reports. [2023]