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Clinical trial Recruiting at 1 site Observational Ages 6 to 17

Improving access to advanced diabetes technology for children with Type 1 Diabetes

Official title: Breaking Health Care Disparities in Access to Advanced Diabetes Technologies in Children With Type 1 Diabetes

Run by Nemours Children's Clinic · NCT05849753 · Data updated 2026-11-12

This study is testing if giving advanced diabetes technology to children and teens with Type 1 Diabetes from lower-income backgrounds can help them manage their condition better.

Quick facts

Study typeObservational
Ages6 Years to 17 Years
SexAll
Enrollment50 (estimated)
SponsorNemours Children's Clinic
Academic / other
Locations2 sites (Jacksonville, Florida and 1 other locations)
StatusRecruiting
StartedJuly 26, 2023
Main results expectedNovember 30, 2026
Study endsDecember 31, 2026
Registry record updatedJuly 20, 2026
Trial IDNCT05849753 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children and adolescents aged 6 to under 18 years with Type 1 Diabetes, poor glycemic control (HbA1c ≥ 8.0%), and from lower socioeconomic backgrounds.

Probably not a fit

Patients with severe skin conditions that prevent the use of diabetes devices or those with chronic medical conditions that complicate diabetes management may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to recruit 50 children and adolescents aged 6 to under 18 years with Type 1 Diabetes (T1D) who have suboptimal control and come from lower socioeconomic backgrounds. Participants will transition to closed-loop diabetes technologies, with the study assessing their diabetes management before and after device use. The study will analyze primary outcomes such as time-in-range and secondary outcomes including HbA1c levels and diabetes-related distress through questionnaires. The research seeks to address disparities in access to diabetes technology among racial and ethnic minorities.

Why it matters

Potential benefit: If successful, this study could significantly improve diabetes management and health outcomes for children with Type 1 Diabetes from disadvantaged backgrounds.

How similar studies have gone: Other studies have shown success in improving diabetes outcomes with similar technology interventions, particularly among underrepresented groups.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

Diagnosis of T1D for at least 1 year based on clinical presentation (polyuria, polydipsia, weight loss, and/or ketoacidosis, or with positive diabetes autoantibodies) on insulin, including injections or open-loop pumps

* HbA1C ≥ 8.0% at least twice within the last 12 months before study initiation, upper limit of HbA1C \<14%
* Be of lower SES, defined based on \< 200% above published US levels of poverty by family size and income, or based on exceptional circumstantial needs in the opinion of the investigators
* Approximately 1/3 AA, 1/3 Hispanic/Latinos, 1/3 non-Hispanic whites. Asians, Pacific Islanders and other ethnic groups however will not be excluded from participation if other criteria met
* History of hypothyroidism on adequate replacement therapy with normal thyroid function will be allowed

Exclusion Criteria:

* Severe eczema or any other skin condition that would limit availability of healthy skin to wear devices
* Chronic medications/medical conditions that could interfere with diabetes management (ADHD medications allowed)
* Chronic seizures, or severe neurodevelopmental delay
* Current use of hybrid closed-loop, automated insulin delivery system
* Significant mental health disorder that in opinion of the investigator would hinder device use

Where it's running

  • Nemours Children's Health
    Jacksonville, Florida, United States     Recruiting
  • Nemours Children's Health
    Orlando, Florida, United States     Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Diabetes Mellitus, Type 1 68Delivery of Health Care 5Equipment and Supplies 2Nemours Children's Clinic 31
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.