RECRUITING

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

Conditions

Type 1 Diabetes T1D Healthy foods Children Youth Nutrition Counseling Diabetes mellitus type 1 Nutrition Honeymoon phase partial remission of diabetes new diagnosis of type 1 diabetes healthy eating Nutrition Intervention

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

NUTRI-Beta Study: A Pilot Clinical Trial for Children With New Diagnosis of Stage 3 Type 1 Diabetes

Quick Facts

Study Start:2024-11-20

Study Completion:2026-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06640478

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Lina Huerta Saenz, MD

CONTACT

717-531-1481

lhuertasaenz@pennstatehealth.psu.edu

Erica N Miller, LPN, CCRC

CONTACT

717-531-5656

emiller25@pennstatehealth.psu.edu

Principal Investigator

Lina Huerta Saenz, MD, FAAP

PRINCIPAL_INVESTIGATOR

Pediatric Endocrinologist, Assistant Professor of Pediatrics, Penn State Health Milton Hershey Medical Center, Penn State College of Medicine

Study Locations (Sites)

Penn State Health Children's

Hershey, Pennsylvania, 17033

United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033

United States

Collaborators and Investigators

Sponsor: Milton S. Hershey Medical Center

Lina Huerta Saenz, MD, FAAP, PRINCIPAL_INVESTIGATOR, Pediatric Endocrinologist, Assistant Professor of Pediatrics, Penn State Health Milton Hershey Medical Center, Penn State College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-20

Study Completion Date2026-06-30

Study Record Updates

Study Start Date2024-11-20

Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

T1D
Healthy foods
Children
Youth
Nutrition Counseling
Diabetes mellitus type 1
Nutrition
Honeymoon phase
partial remission of diabetes
new diagnosis of type 1 diabetes
healthy eating
Nutrition Intervention

Additional Relevant MeSH Terms

Type 1 Diabetes