Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active NA study of Type 1 Diabetes, sponsored by Milton S. Hershey Medical Center.
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 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Number of subjects screened over the course of the study
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 |
What the registry record for NCT06640478 still lists
NCT06640478 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (97% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06640478's enrollment target sits among peer trials
20 152nd of 198 higher than 41 of 198 other Type 1 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
REAL-Fam Feasibility Study for Youth Diabetes Management
RECRUITING · NA
-
AIDANET Pediatrics
RECRUITING · NA
-
A Study Comparing Dexcom Continuous Glucose Monitoring to Point of Care Glucose Testing for the Management of Hospital and Post-Discharge Subjects With Type 1 Diabetes
RECRUITING · NA
-
Safety and Feasibility of a Self-Learning Bolus Calculator With Simplified Meal Announcement in Adolescents With Type 1 Diabetes Using Automated Insulin Delivery
RECRUITING · NA
-
EMPoWER Study - Strengths-based Behavioral Intervention for Youth With Type 1 Diabetes
RECRUITING · NA
-
Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00573339 · 20 participants
Cardiac Magnetic Resonance Imaging (MRI) Normal Reference Control Group Testing
- NCT00692939 · 20 participants · Phase 1
Autologous Stem Cell Transplantation for Crohn's Disease
- NCT00967785 · 20 participants · Phase 1
A Phase I Study of Mozobil in the Treatment of Patients With WHIMS
- NCT01406691 · 20 participants · Phase 4
Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI