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NCT06640478 · ClinicalTrials.gov record · last posted 2026-08-17

A 12-week Pilot Nutrition Intervention for Children With New Diagnosis of Stage 3 Type 1 Diabetes (T1D)

Study acronym: NUTRI-Beta
StatusActive, Not Recruiting
PhaseNot applicable
Started2024-11-20
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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

Protocol amendment history 2 changes detected by DataLookout

2026-08-18
notable
Primary completion pushed: 2026-06-30 → 2026-10-30
2026-08-18
minor
Completion pushed: 2026-06-30 → 2026-10-30
Trial Details
NCT Number NCT06640478
Lead Sponsor Milton S. Hershey Medical Center
Conditions Type 1 Diabetes
Enrollment 20 participants
Start Date 2024-11-20
Primary Completion 2026-10-30 (estimated)
Study Completion 2026-10-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-17