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Personalized Dietary Management for Type 2 Diabetes (DiaTeleMed Trial)

N/A
Recruiting
Led By Mary Sevick, ScD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must be an adult 21-80 years of age
Be older than 18 years old
Must not have
Those who have been diagnosed with a chronic active inflammatory or neoplastic disease in the past 3 years
Those who have been prescribed: (1) antibiotics or antifungals in the past 3 months, (2) diabetic medications other than metformin, (3) weight loss medications, (4) chronic use of steroids or immunosuppressants, (5) atypical antipsychotics, and (6) chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a Standardized or Personalized treatment plan is better for early-stage T2D than the Usual Care Control.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Since this trial focuses on dietary management rather than medication or invasive procedures, side effects are minimal but may include potential discomfort from changing eating habits such as digestive changes or food cravings.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 21 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with a long-term inflammatory or cancerous disease in the last 3 years.
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I have not taken antibiotics, antifungals, certain diabetes drugs, weight loss drugs, steroids, immunosuppressants, atypical antipsychotics, or chemotherapy in the last 3 months.
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I need a special diet due to kidney disease, cirrhosis, or HIV.
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I am unable or unwilling to give my consent for participation.
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I have a long-term gut condition like Crohn's disease or celiac.
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I need a walker or cane to walk 2 city blocks.
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I am willing to accept any treatment group I am assigned to.
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I have a chronic condition like Cushing's, acromegaly, or hyperthyroidism.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean Amplitude of Glycemic Excursion (MAGE)
Secondary study objectives
HbA1c Levels

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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 Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,408 Previous Clinical Trials
855,488 Total Patients Enrolled
National Institute of Nursing Research (NINR)NIH
600 Previous Clinical Trials
10,377,518 Total Patients Enrolled
Mary Sevick, ScDPrincipal InvestigatorNYU Langone Health

Media Library

Isocaloric Mediterranean Diet Advice Clinical Trial Eligibility Overview. Trial Name: NCT05046886 — N/A
Type 2 Diabetes Research Study Groups: Personalized, Usual Care Control (UCC), Standardized
Type 2 Diabetes Clinical Trial 2023: Isocaloric Mediterranean Diet Advice Highlights & Side Effects. Trial Name: NCT05046886 — N/A
Isocaloric Mediterranean Diet Advice 2023 Treatment Timeline for Medical Study. Trial Name: NCT05046886 — N/A
~65 spots leftby Nov 2025
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