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

Running, not enrolling · Not applicable

Conditions studied: Type 1 Diabetes

In brief

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

Key facts

Study ID: NCT06640478
Run by: Milton S. Hershey Medical Center
People needed: 20
Starts: 2024-11-20
Expected to finish: 2026-06-30
Last updated by the study team: 2026-03-04

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Willing and able to give assent and to have a parent or legal guardian to provide informed consent
Less or equal than 60 days from T1D diagnosis based on American Diabetes Association criteria, and metabolically stable per study physician assessment
Boys and girls (Any Tanner stage), 6-17 years of age, at time of enrollment visit
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
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
Capability to eat different types of food by mouth
Daily use of a 24-hour continuous glucose monitor by the time of the enrollment visit
Willing and being able to give assent and have a parent or legal guardian provide informed consent

You may not qualify if…

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)
Concurrent or recent (within the past 30 days of screening) use of non-insulin therapies to control hyperglycemia including immunosuppressive therapies
Chronic inflammatory or autoimmune diseases with exception of stable autoimmune thyroid disease
Children requiring enteral feeds or parenteral nutrition support
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.
Use of glucocorticoids or other immunosuppressive agents within 30 days of T1D diagnosis
Use of medications known to influence glucose intolerance within 30 days of T1D diagnosis
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
Prior diagnosis or positive screening of food sensory disorders
Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation to the study results

Where it is running

Penn State Health Children's — Hershey, Pennsylvania, United States
Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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