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Can a healthy diet prolong the 'Honeymoon Phase' in kids with type 1 diabetes?

NCT ID NCT06640478

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 18, 2026 · Updated 3 times

Summary

This pilot study is testing whether giving children (ages 6-17) newly diagnosed with stage 3 type 1 diabetes free weekly healthy foods and intensive nutrition counseling can help preserve their remaining insulin production. The study will enroll 20 children and measure how feasible and acceptable the program is, while also exploring if it can extend the 'honeymoon phase'—a period when the pancreas still makes some insulin. Both groups will continue standard insulin therapy.

What this could mean

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

Active substance
Dietary counseling and free weekly produce
What this could lead to
If it works, this could point toward a way to help children with new type 1 diabetes keep their remaining insulin-producing cells working longer, potentially easing disease management.
What could go wrong
This is a very small pilot study (20 children) focused on feasibility, not proof of effectiveness. The diet intervention may not meaningfully change the course of the disease.

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

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Oct 2026

An estimate. End dates often move.

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

6 to 17 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: 1. Willing and able to give assent and to have a parent or legal guardian to provide informed consent 2. Less or equal than 60 days from T1D diagnosis based on American Diabetes Association criteria, and metabolically stable per study physician assessment 3. Boys and girls (Any Tanner stage), 6-17 years of age, at time of enrollment visit 4. Evidence of at least one positive T1D autoantibody (excluding insulin antibodies in those who have received ≥ 2 weeks of exogenous insulin therapy) either through clinically obtained labs at time of diagnosis or as obtained at the screening visit 5. Children with new diagnosis of T1D need to be established patients from Penn State Health- Pediatric diabetes clinic at the time of the enrollment visit 6. Capability to eat different types of food by mouth 7. Daily use of a 24-hour continuous glucose monitor by the time of the enrollment visit 8. Willing and being able to give assent and have a parent or legal guardian provide informed consent Exclusion Criteria: 1. Children with new diagnosis of T1D who are not metabolically stable (E.g. acute dehydration, severe hyperglycemia with moderate/large ketones at the time of the enrollment visit) 2. Concurrent or recent (within the past 30 days of screening) use of non-insulin therapies to control hyperglycemia including immunosuppressive therapies 3. Chronic inflammatory or autoimmune diseases with exception of stable autoimmune thyroid disease 4. Children requiring enteral feeds or parenteral nutrition support 5. Diagnosis of celiac disease or being actively evaluated for possible celiac disease, inflammatory bowel disease or any underlying illness cause acute or chronic intestinal malabsorption. 6. Use of glucocorticoids or other immunosuppressive agents within 30 days of T1D diagnosis 7. Use of medications known to influence glucose intolerance within 30 days of T1D diagnosis 8. Food allergies (nuts, soy, seafood, milk-protein, or as deemed by the principal investigator) that are a barrier for consumption of a balanced diet that meets nutrient requirements 9. Prior diagnosis or positive screening of food sensory disorders 10. Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation to the study results

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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

  • Penn State Health Children's

    Hershey, Pennsylvania, 17033, United States

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

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