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NCT07535502Not yet recruiting

Food is Medicine in Pediatric Patients With Diabetes

The Effect of a Novel Food is Medicine Program on Outcomes in Pediatric Patients With Diabetes: A Randomized Controlled Trial

Source: ClinicalTrials.gov · Last updated 25 Sept 2026

Brief summary (registry, in English)

The objective of this randomized controlled trial is to evaluate the effect of novel Food is Medicine Programming in the form of medically tailored pre-packaged meals for pediatric patients with Type 1 Diabetes. The provision of medically-tailored meals to children and adolescents with diabetes that have potential food security or access concerns in addition to nutrition counseling will improve clinical outcomes, decrease healthcare utilization, and improve health-related quality of life (HRQOL). Consulting with a Registered Dietician is the established multidisciplinary standard of care for pediatric patients with diabetes at UMass. Community Servings provides a medically-tailored pre-packaged meal plan designed for pediatric patients with Type 1 Diabetes. The addition of Community Servings to the current standard of care in pediatric patients with potential food security or access concerns will further improve clinical, decrease healthcare utilization, and improve HRQOL outcomes in pediatric patients with Type 1 Diabetes.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
50 (estimated)
First submitted
30 Mar 2026
Start date
5 Oct 2026
Primary completion date
31 Dec 2027
Lead sponsor
University of Massachusetts, Worcester
NCT number
NCT07535502

What you commit to

  • Study type: Interventional
  • Planned participants: 50
  • From 5 Oct 2026 to the primary completion date, 31 Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Celiac disease or severe gluten allergy

Other

  • Congenital, genetic, or chronic comorbidities
  • DCF Custody
  • Pregnant women
  • Prisoners
  • Non-English speaking subjects

Who the study is looking for

  • 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

Age in the registry: 5 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UMass Memorial Children's Medical Center
Coordinator of this site? Confirm its status
WorcesterUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.