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Low-Carb diet tested in teens with type 1 diabetes: safe or risky?

NCT ID NCT04955691

Knowledge-focused Sponsor: Yale University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study from Yale University looked at what happens when teenagers with type 1 diabetes follow a very low carbohydrate diet for two weeks. Nineteen participants ate either a low-carb or standard diet to see how it affected their blood sugar levels and brain function. The goal was to understand if these diets are safe and helpful for young people managing diabetes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
low carbohydrate diet
What this could lead to
If successful, this could help doctors give better advice on whether low-carb diets are safe and effective for managing blood sugar in young people with type 1 diabetes.
What could go wrong
This was a very small, short-term study with only 19 participants, so results may not apply to everyone. The diet is restrictive and may be hard to follow long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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

19 people

The number who actually took part.

Started

Jul 2021

Finished

Aug 2024

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

12 to 21 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: * Diagnosis of type 1 diabetes for at least 1 year * Hemoglobin A1c level \< 10% within the past 2 months * Provision of signed and dated informed consent form by the adult (if person is at least 18 years old) or parent and assent form if the participant is \<18 years old. * Stated willingness to comply with all study procedures and availability for the duration of the study * All sexes are eligible * Diagnosis of type 1 diabetes for at least 1 year * Insulin pump use for at least 2 months. * Ability to perform daily blood ketone checks, wear a continuous glucose monitor, willing to wear an activity monitor, willing to adhere to the study diets and keep a diet journal. * For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of the dietary intervention. * For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner Exclusion Criteria: * Current use of glucose-lowering agents other than insulin * Unstable psychiatric disorders, including eating disorders * Weight loss medications within the last 6 months * Pregnancy or lactation, or planning pregnancy within the next 6 months * BMI \< 19 kg/m2 for individuals 18 years of age or older * BMI \< 5%ile for individuals under 18 years * Weight less than 49 kg or 108 pounds * Other medical conditions that may interfere with glucose metabolism and insulin sensitivity

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus

As listed by the trial registrant

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

TYPE1DIABETES, low carbohydrate diet

Contacts and locations

Locations

  • Yale-New Haven Hospital

    New Haven, Connecticut, 06511, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.