Tailored diets may help tame type 2 diabetes

NCT ID NCT05046886

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 ยท Last updated Jun 27, 2026

Summary

This study tested whether personalized dietary advice helps people with early-stage type 2 diabetes control their blood sugar better than standard advice or usual care. About 255 participants were split into three groups: personalized diet, standardized diet, or usual care. Researchers used continuous glucose monitors to track blood sugar changes and also measured HbA1c levels.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

294 people

The number who actually took part.

Started

Dec 2021

Finished

Jan 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • NYU Langone Health

    New York, New York, 10016, United States

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