Food is Medicine for Children with Type 1 Diabetes

This study is looking at whether providing special meals can help children and teenagers with Type 1 Diabetes. It's called "Food is Medicine in Pediatric Patients With Diabetes." Participants will receive 10 medically-tailored meals per week from Community Servings for 6 months. They will also get standard nutrition counseling from a registered dietitian. The study aims to see if these meals improve health outcomes related to nutrition and diabetes, and also improve their quality of life. We are looking for about 50 children and teenagers, aged 5 to 17, who have Type 1 Diabetes, are current patients at UMMMC Pediatric Endocrinology Clinic, have had diabetes for at least 3 months, and have public health insurance. The study will measure these improvements over 12 months. The current status of the study is unclear.

Study design
This is an interventional study with a planned enrollment of 50 participants. Participants will be randomly assigned to either receive the Community Servings meal plan or not.
What's involved
Participants will receive 10 medically-tailored meals per week for 6 months and nutrition counseling. They will also complete quality of life and social driver of health surveys at baseline, 3 months, 6 months, and 12 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months, with assessments at 3, 6, and 12 months after enrollment.

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NCT07535502

Food is Medicine in Pediatric Patients With Diabetes

Not Yet Recruiting
NAAges 5–17InterventionalTreatment
University of Massachusetts, Worcester
~50 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:Community ServingsPedsQL SurveyNutrition CounselingSDOH Survey

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Difference in nutrition-related clinical outcomes
Measured over 12 months
+1 more outcome measured
Type I Diabetes
Pediatrics
Food Insecurity
1 sites across 1 states
Massachusetts1
  • Lawrence Rhein, MD, MPH · PRINCIPAL_INVESTIGATOR · UMass Chan Medical School
  • Arvin Garg, MD, MPH · PRINCIPAL_INVESTIGATOR · UMass Chan Medical School
  • Leslie Soyka, MD · PRINCIPAL_INVESTIGATOR · UMass Chan Medical School

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Eligibility criteria

Inclusion

Current patients of the UMMMC Pediatric Endocrinology Clinic
Children and Adolescents less than or equal to 17 years of age at the time of enrollment
Diagnosed with Type 1 Diabetes at least 3 months ago
Public (MassHealth or Medicaid) Health Insurance

Exclusion

Celiac disease or severe gluten allergy
Congenital, genetic, or chronic comorbidities
DCF Custody
Pregnant women
Prisoners
Non-English speaking subjects
  • Difference in nutrition-related clinical outcomes12 months

    The primary outcome measure is the difference in clinical outcomes between the control and intervention groups. Nutrition-related outcomes will include growth metrics (Z-score and percentile rank), and height and weight will be combined to report Body Mass Index (BMI) in kg/m\^2 metrics.

  • Difference in Diabetes-related clinical outcomes12 months

    One primary outcome measure is the difference in clinical outcomes between the control and intervention groups. Diabetes outcomes will include changes in insulin dosage (units/mL/day), continuous glucose monitoring metrics (glucose in mg/dL, time spent at range intervals and variability as percentages), and Hemoglobin A1c (percentage).