Type 2 DiabetesDiaTeleMedNCT05046886
Personalized Dietary Management in Type 2 Diabetes
A study testing Standardized and Personalized Guidance to Minimize Postprandial Glycemic Response (PPGR) in people with Type 2 Diabetes, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Standardized and Personalized Guidance to Minimize Postprandial Glycemic Response (PPGR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2021to 16 Jan 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Type 2 diabetes (T2D) is an epidemic in the United States, affecting 30.2 million people. Vascular complications of T2D (heart and kidney disease, stroke, retinopathy, and amputation) are associated with poor glycemic control. However, the results of recent clinical trials (ACCORD, ADVANCE, VADT) to aggressively reduce HbA1c with medications have not resulted in cardiovascular benefits and may even be harmful due to risks of polypharmacy. Although HbA1c is directly associated with vascular complications, there is growing evidence that glycemic variability (or GV, defined by postprandial excursions and hypoglycemic nadirs) may be a better treatment target.
Postprandial glycemic excursions are primarily driven by diet. However, the results of dietary intervention studies intended to control postprandial excursions in T2D patients have been mixed and mostly negative. Importantly, these studies used one-size-fits-all dietary strategies that did not consider the fact that individuals vary greatly in their glycemic response to same foods. One-size-fits-all approaches are frustrating to T2D patients who have glycemic excursions despite their best efforts. And failure to adequately manage glycemia in the early stages of the disease has long-term vascular consequences that are not entirely remedied by subsequent, better glycemic control.
Personalized medicine is defined as "the right treatment for the right person at the right time" and has grown out of dramatic advances in genetic testing, molecular profiling, and mobile health (mHealth) technology. Personalizing dietary recommendations to the patient's unique glycemic response to food, using an algorithm derived from the gut microbiome to predict postprandial glycemic response (PPGR), is a proactive approach to early T2D dietary management that could increase mastery and self-management success beyond what can be achieved through a one-size-fits-all diet. The investigators also argue that such an approach could reduce glycemic exposure, preserve β-cell function, and reduce downstream metabolic consequences of T2D.
The purpose of this clinical trial is to determine the efficacy of a Personalized behavioral approach for dietary management of early-stage T2D, versus a Standardized behavioral intervention (which uses one-size-fits-all dietary recommendations), versus a UCC.
Primary aims. Compared to UCC, the study will determine the incremental benefits of Standardized and Personalized interventions on mean amplitude of glycemic excursion (or MAGE, the most frequently used measure of GV).
Hypothesis 1: MAGE-Personalized< MAGE-Standardized < MAGE-UCC at 6 months.
Secondary aim. At each time point, the study will describe the impact of the intervention on HbA1c.
Exploratory aims. The study will describe between-group differences in β-cell deterioration (HOMA-β) and the need to escalate the medication regimen. The study also will describe the mediating effects of changes in self-efficacy on the relationship between randomization assignment and GV, HbA1c, and HOMA-β. The study will describe the impact of the interventions on alternative measures of GV (standard deviation, coefficient of variation, Continuous Overall Net Glycemic Action, area under the curve, and frequency of out-of-range and seriously out-of-range glucose values).
Study Population
The study population includes adult men and women, 21-80 years of age, living in the New York City Metropolitan area and who have early-stage type 2 diabetes (defined as an HbA1c<8.0% and managed on lifestyle alone or lifestyle+metformin).
Description of Sites/Facilities Enrolling Participants/Sample size and Randomization
The study will enroll participants from NYU Langone Faculty Group Practices and NYU Langone affiliates located in the New York City metropolitan area. The study expects to enroll 300 individuals, and randomize 255. Participants will be stratified by medication regimen (metformin versus no metformin) and randomized within strata.
Description of Study Intervention/Experimental Manipulation
Eligible participants will be stratified by treatment with metformin (yes or no) and randomized with equal allocation to UCC, Standardized, or Personalized. All 3 groups will receive usual care plus education regarding the nature of T2D, consequences of uncontrolled glycemia, performance and interpretation of capillary glucose monitoring, and the importance of medication adherence. Participants randomized to Standardized will also experience Social Cognitive Theory (SCT)-based behavioral counseling to follow an isocaloric Mediterranean diet. Participants randomized to Personalized will receive the same SCT-based counseling as Standardized, plus personalized guidance to minimize PPGR, using a gut microbiome-based algorithm.
Measurements will occur at 0, 3, and 6 months. [screening A1c usually takes place before T=0]
- Conditions
- Type 2 Diabetes
- Being tested
- Standardized, Usual Care Control (UCC), Personalized Guidance to Minimize Postprandial Glycemic Response (PPGR)
- Keywords
- precision nutrition, Mediterranean diet, behavioral intervention
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StandardizedBehavioural
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.
Usual Care Control (UCC)Behavioural
Participants are instructed to follow a Mediterranean-style diet,
Personalized Guidance to Minimize Postprandial Glycemic Response (PPGR)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Control (UCC) | Other | Baseline advice about the Mediterranean-style diet and attention control. Receives: Behavioral: Usual Care Control (UCC) |
| Standardized | Active comparator | One-size-fits-all dietary counseling to follow a Mediterranean-style diet Receives: Behavioral: Standardized; Behavioral: Usual Care Control (UCC) |
| Personalized | Active comparator | Dietary counseling to follow a Mediterranean-style diet personalized to reduce postprandial glycemic response Receives: Behavioral: Standardized; Behavioral: Usual Care Control (UCC); Behavioral: Personalized Guidance to Minimize Postprandial Glycemic Response (PPGR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Month 6
Secondary outcomes (2)
HbA1c Levels
Glycosylated hemoglobin will be evaluated from blood sampling (~10 ml) obtained during Clinical Translational Research Center (CTRC) measurement visits, evaluated in the NYU CLIA-certified lab. . Levels from 5.7% to 6.4% indicate prediabetes, while 6.5% or higher typically indicates a diabetes diagnosis.
Measured: Month 3
HbA1c Levels
Glycosylated hemoglobin will be evaluated from blood sampling (~10 ml) obtained during CTRC measurement visits, evaluated in the NYU CLIA-certified lab. Levels from 5.7% to 6.4% indicate prediabetes, while 6.5% or higher typically indicates a diabetes diagnosis.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start14 Dec 2021
- Primary completion22 May 2025
- Study completion16 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Collin J Popp, PhD, RD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046886
- Sponsor's protocol ID
- 20-01088
- Other IDs
- 1R01NR018916
- Acronym
- DiaTeleMed
- Status last verified
- May 2026
- First submitted
- 8 Sep 2021
- Last updated
- 18 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
Publications
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.
PubMed 39049121Berube 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.
PubMed 38978573
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Dietary Management in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05046886
- Acronym / sponsor ID
- DiaTeleMed / 20-01088
- Conditions
- Type 2 Diabetes
- Keywords
- precision nutrition, Mediterranean diet, behavioral intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- 22 May 2025 (actual)
- Study completion
- 16 Jan 2026 (actual)
- First posted
- 16 Sep 2021 (actual)
- Results
- Posted 18 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Type 2 diabetes (T2D) is an epidemic in the United States, affecting 30.2 million people. Vascular complications of T2D (heart and kidney disease, stroke, retinopathy, and amputation) are associated with poor glycemic control. However, the results of recent clinical trials (ACCORD, ADVANCE, VADT) to aggressively reduce HbA1c with medications have not resulted in cardiovascular benefits and may even be harmful due to risks of polypharmacy. Although HbA1c is directly associated with vascular complications, there is growing evidence that glycemic variability (or GV, defined by postprandial excursions and hypoglycemic nadirs) may be a better treatment target.
Postprandial glycemic excursions are primarily driven by diet. However, the results of dietary intervention studies intended to control postprandial excursions in T2D patients have been mixed and mostly negative. Importantly, these studies used one-size-fits-all dietary strategies that did not consider the fact that individuals vary greatly in their glycemic response to same foods. One-size-fits-all approaches are frustrating to T2D patients who have glycemic excursions despite their best efforts. And failure to adequately manage glycemia in the early stages of the disease has long-term vascular consequences that are not entirely remedied by subsequent, better glycemic control.
Personalized medicine is defined as "the right treatment for the right person at the right time" and has grown out of dramatic advances in genetic testing, molecular profiling, and mobile health (mHealth) technology. Personalizing dietary recommendations to the patient's unique glycemic response to food, using an algorithm derived from the gut microbiome to predict postprandial glycemic response (PPGR), is a proactive approach to early T2D dietary management that could increase mastery and self-management success beyond what can be achieved through a one-size-fits-all diet. The investigators also argue that such an approach could reduce glycemic exposure, preserve β-cell function, and reduce downstream metabolic consequences of T2D.
The purpose of this clinical trial is to determine the efficacy of a Personalized behavioral approach for dietary management of early-stage T2D, versus a Standardized behavioral intervention (which uses one-size-fits-all dietary recommendations), versus a UCC.
Primary aims. Compared to UCC, the study will determine the incremental benefits of Standardized and Personalized interventions on mean amplitude of glycemic excursion (or MAGE, the most frequently used measure of GV).
Hypothesis 1: MAGE-Personalized< MAGE-Standardized < MAGE-UCC at 6 months.
Secondary aim. At each time point, the study will describe the impact of the intervention on HbA1c.
Exploratory aims. The study will describe between-group differences in β-cell deterioration (HOMA-β) and the need to escalate the medication regimen. The study also will describe the mediating effects of changes in self-efficacy on the relationship between randomization assignment and GV, HbA1c, and HOMA-β. The study will describe the impact of the interventions on alternative measures of GV (standard deviation, coefficient of variation, Continuous Overall Net Glycemic Action, area under the curve, and frequency of out-of-range and seriously out-of-range glucose values).
Study Population
The study population includes adult men and women, 21-80 years of age, living in the New York City Metropolitan area and who have early-stage type 2 diabetes (defined as an HbA1c<8.0% and managed on lifestyle alone or lifestyle+metformin).
Description of Sites/Facilities Enrolling Participants/Sample size and Randomization
The study will enroll participants from NYU Langone Faculty Group Practices and NYU Langone affiliates located in the New York City metropolitan area. The study expects to enroll 300 individuals, and randomize 255. Participants will be stratified by medication regimen (metformin versus no metformin) and randomized within strata.
Description of Study Intervention/Experimental Manipulation
Eligible participants will be stratified by treatment with metformin (yes or no) and randomized with equal allocation to UCC, Standardized, or Personalized. All 3 groups will receive usual care plus education regarding the nature of T2D, consequences of uncontrolled glycemia, performance and interpretation of capillary glucose monitoring, and the importance of medication adherence. Participants randomized to Standardized will also experience Social Cognitive Theory (SCT)-based behavioral counseling to follow an isocaloric Mediterranean diet. Participants randomized to Personalized will receive the same SCT-based counseling as Standardized, plus personalized guidance to minimize PPGR, using a gut microbiome-based algorithm.
Measurements will occur at 0, 3, and 6 months. [screening A1c usually takes place before T=0]
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care Control (UCC) | Other | Behavioral: Usual Care Control (UCC)Baseline advice about the Mediterranean-style diet and attention control. |
| Standardized | Active comparator | Behavioral: Standardized, Behavioral: Usual Care Control (UCC)One-size-fits-all dietary counseling to follow a Mediterranean-style diet |
| Personalized | Active comparator | Behavioral: Standardized, Behavioral: Usual Care Control (UCC), Behavioral: Personalized Guidance to Minimize Postprandial Glycemic Response (PPGR)Dietary counseling to follow a Mediterranean-style diet personalized to reduce postprandial glycemic response |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StandardizedParticipants 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. | Behavioural | Personalized, Standardized |
| Usual Care Control (UCC)Participants are instructed to follow a Mediterranean-style diet, | Behavioural | Personalized, Standardized, Usual Care Control (UCC) |
| Personalized Guidance to Minimize Postprandial Glycemic Response (PPGR)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. | Behavioural | Personalized |
Primary outcome
Mean Amplitude of Glycemic Excursion (MAGE)
Time frame: Month 3
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.
Mean Amplitude of Glycemic Excursion (MAGE)
Time frame: Month 6
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.
2 secondary outcomes
HbA1c Levels
Time frame: Month 3
HbA1c Levels
Time frame: Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39049121Berube 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.
- Derived from this study: PubMed 38978573Berube 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Collin J Popp, PhD, RD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized and Personalized Guidance to Minimize Postprandial Glycemic Response (PPGR) in people with Type 2 Diabetes, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Amplitude of Glycemic Excursion (MAGE) (time frame: Month 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05046886, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.