NCT05046886

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
294

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Dec 2021

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 16, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

December 14, 2021

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2026

Completed
Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

3.4 years

First QC Date

September 8, 2021

Last Update Submit

May 4, 2026

Conditions

Type 2 Diabetes

Keywords

precision nutritionMediterranean dietbehavioral intervention

Outcome Measures

Primary Outcomes (2)

  • Mean Amplitude of Glycemic Excursion (MAGE)

    MAGE will be evaluated via a continuous glucose monitor (CGM), which captures interstitial glucose readings every 15 minutes for up to 2 weeks from a sensor inserted into the participant's upper arm.

    Month 3

  • Mean Amplitude of Glycemic Excursion (MAGE)

    MAGE will be evaluated via a continuous glucose monitor (CGM), which captures interstitial glucose readings every 15 minutes for up to 2 weeks from a sensor inserted into the participant's upper arm.

    Month 6

Secondary Outcomes (2)

  • HbA1c Levels

    Month 3

  • HbA1c Levels

    Month 6

Study Arms (3)

Usual Care Control (UCC)

OTHER

Baseline advice about the Mediterranean-style diet and attention control.

Behavioral: Usual Care Control (UCC)

Standardized

ACTIVE COMPARATOR

One-size-fits-all dietary counseling to follow a Mediterranean-style diet

Behavioral: StandardizedBehavioral: Usual Care Control (UCC)

Personalized

ACTIVE COMPARATOR

Dietary counseling to follow a Mediterranean-style diet personalized to reduce postprandial glycemic response

Behavioral: StandardizedBehavioral: Usual Care Control (UCC)Behavioral: Personalized Guidance to Minimize Postprandial Glycemic Response (PPGR)

Interventions

Personalized Guidance to Minimize Postprandial Glycemic Response (PPGR)BEHAVIORAL

Participants are instructed to follow a Mediterranean-style diet. Dietary counseling is paired with SCT-based behavioral counseling, which focuses on the role played by self-referent thought in the maintenance of behavior change. Self-efficacy (e.g., the participant's confidence in their ability to engage in healthier behavior) is derived from four major sources of information: mastery experiences, social modeling, verbal persuasion, and physiological states. Participants self-monitor their diet using a mobile app and receive real-time feedback from the app on their predicted PPGR to meals and snacks at the time they enter them into their smart phone. PPGR predictions will be generated from a gut microbiome-based machine learning algorithm.

Personalized
StandardizedBEHAVIORAL

Participants are instructed to follow a Mediterranean-style diet. Dietary counseling is paired with SCT-based behavioral counseling, which focuses on the role played by self-referent thought in the maintenance of behavior change. Self-efficacy (e.g., the participant's confidence in their ability to engage in healthier behavior) is derived from four major sources of information: mastery experiences, social modeling, verbal persuasion, and physiological states. Participants self-monitor their diet using a mobile app and receive real-time feedback from the app on macronutrient distribution.

PersonalizedStandardized
Usual Care Control (UCC)BEHAVIORAL

Participants are instructed to follow a Mediterranean-style diet,

PersonalizedStandardizedUsual Care Control (UCC)

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • must be an adult 21-80 years of age
  • must be diagnosed with early-stage T2D defined as HbA1c\<8% and managed for the past 3 months on a diabetes regimen that included lifestyle plus metformin.
  • those who are willing and able to use a smart phone to self monitor their diet and to attend WebEx sessions

You may not qualify if:

  • those who have conditions or treatments likely to alter the underlying function of the microbiome, an insulin response that is driven by factors other than glycemic response to food, conditions/treatments that make it difficult to isolate the true nature of the relationship between randomization assignment and weight loss, characteristics or preferences that would preclude meaningful participation in the study
  • those who are unable or unwilling to adhere to an intervention that requires dietary self-monitoring
  • 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.
  • those who are pregnant, planning to become pregnant during the study period, or become pregnant during the study
  • those who have a chronic disease that affects energy/glucose metabolism (e.g., Cushing's syndrome, acromegaly, hyperthyroidism)
  • those who require special dietary management (end-stage kidney disease, cirrhosis, HIV)
  • those who are unable or unwilling to provide informed consent
  • those who are unable to participate meaningfully in an intervention that involves self-monitoring using software available in English (e.g., uncorrected sight impairment, illiterate, non-English-speaking, dementia)
  • those who are unwilling to accept randomization assignment
  • those who have limited control over diet (e.g., are homeless or institutionalized, in a nursing home or personal care facility, or incarcerated)
  • those who have previously had bariatric surgery, or are unwilling to delay bariatric surgery for the next 7 months
  • those who are unable to walk without a walker or cane for 2 city blocks
  • those who have been diagnosed with a chronic active inflammatory or neoplastic disease in the past 3 years
  • those who have been diagnosed with a chronic gastrointestinal disorder (e.g., inflammatory bowel disease or celiac disease)
  • those who have an active substance use disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Related Publications (2)

  • Berube LT, Popp CJ, Curran M, Hu L, Pompeii ML, Barua S, Bernstein E, Salcedo V, Li H, St-Jules DE, Segal E, Bergman M, Williams NJ, Sevick MA. Diabetes Telemedicine Mediterranean Diet (DiaTeleMed) Study: study protocol for a fully remote randomized clinical trial evaluating personalized dietary management in individuals with type 2 diabetes. Trials. 2024 Jul 25;25(1):506. doi: 10.1186/s13063-024-08337-w.

    PMID: 39049121DERIVED

  • Berube LT, Popp CJ, Curran M, Hu L, Pompeii ML, Barua S, Bernstein E, Salcedo V, Li H, St-Jules DE, Segal E, Bergman M, Williams NJ, Sevick MA. Diabetes Telemedicine Mediterranean Diet (DiaTeleMed) Study: study protocol for a fully remote randomized clinical trial evaluating personalized dietary management in individuals with type 2 diabetes. Res Sq [Preprint]. 2024 Jun 25:rs.3.rs-4492352. doi: 10.21203/rs.3.rs-4492352/v1.

    PMID: 38978573DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Collin J Popp, PhD, RD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Randomization is performed by the statistician blind to participant identity and baseline data. It is not possible to blind interventionists to randomization group. Outcome assessors will be blind to randomization assignment to the extent possible.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2021

First Posted

September 16, 2021

Study Start

December 14, 2021

Primary Completion

May 22, 2025

Study Completion

January 16, 2026

Last Updated

May 6, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access Criteria
The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to mary.sevick@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US(1)