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NCT06640478 · ClinicalTrials.gov registry record · NA
A 12-week Pilot Nutrition Intervention for Children With New Diagnosis of Stage 3 Type 1 Diabetes (T1D)
A NA study of Type 1 Diabetes, sponsored by Milton S. Hershey Medical Center.
- Active
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT06640478 is a NA study of Type 1 Diabetes that is active but no longer recruiting, run by Milton S. Hershey Medical Center. The registered enrollment target is 20 participants, below the 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT06640478, a NA study of Type 1 Diabetes, is active but no longer recruiting, sponsored by Milton S. Hershey Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this research study is to investigate the effects of a combination of weekly distribution of healthy foods and intensive nutrition counseling as complementary therapies to the standard insulin therapy in children with new diagnosis of stage 3 type 1 diabetes (T1D). Feasibility, acceptability, and fidelity of this intervention will be measured. We will also explore the likelihood of prolonging the honeymoon phase of T1D in the intervention study group. Comparisons will be made between this combined nutrition intervention and free healthy foods vs. current standard nutrition counseling. Both study groups will receive standard of care treatment for T1D (insulin therapy). The results of this study could inform future research that will ultimately lead to design of a larger clinical trial testing implementation of novel medical nutrition therapies for children newly diagnosed with stage 3 of T1D, and may lead to prolongation of the honeymoon phase. The overall goal is to promote the beta cell function survival and to reduce the progression to stage 4 of T1D. Condition or Disease: * Type 1 Diabetes Mellitus * New Diagnosis of Stage 3 Type 1 Diabetes ≤ 60days Intervention/Treatment: \- Weekly Free Healthy Foods + Intensive Nutrition Counseling for 12 weeks
Conditions Studied
Interventions
- OTHER NUTRI-Beta Counseling
- DIETARY_SUPPLEMENT Standard dietary counseling
- DIETARY_SUPPLEMENT Free weekly produce foods
Study Locations (2)
Pennsylvania
- Penn State Health Children's - Hershey
- Penn State Milton S. Hershey Medical Center - Hershey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-11-20 |
| Est. Completion | 2026-06-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06640478
The ClinicalTrials.gov registry entry for NCT06640478 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (98% lower). The listed sponsor is Milton S. Hershey Medical Center, which has 396 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 3 interventions - of which NUTRI-Beta Counseling is the first listed.
NCT06640478 reports 2 study locations spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06640478 about?
NCT06640478 is a clinical study titled "A 12-week Pilot Nutrition Intervention for Children With New Diagnosis of Stage 3 Type 1 Diabetes (T1D)". The purpose of this research study is to investigate the effects of a combination of weekly distribution of healthy foods and intensive nutrition counseling as complementary therapies to the standard insulin therapy in children with new diagnosis of stage 3 type 1 diabetes (T1D). Feasibility, accept...
What is the current status of trial NCT06640478?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2024-11-20. Estimated completion is 2026-06-30.
What conditions does trial NCT06640478 study?
This clinical trial studies the following conditions: Type 1 Diabetes.
What interventions are being tested in trial NCT06640478?
The interventions under investigation include: NUTRI-Beta Counseling (OTHER), Standard dietary counseling (DIETARY_SUPPLEMENT), Free weekly produce foods (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT06640478?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06640478 being conducted?
This trial has 2 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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