Breaking Disparities in Access to Advanced Diabetes Technologies in Children With Type 1 Diabetes

Launched by NEMOURS CHILDREN'S CLINIC · May 7, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how to improve diabetes management in children and teenagers with Type 1 Diabetes (T1D) who are currently struggling to keep their blood sugar levels in a healthy range. The focus is on providing advanced diabetes technology, specifically closed-loop systems, which can help automatically adjust insulin delivery based on blood sugar levels. The study aims to include 50 children aged 6 to 17 from lower-income families, with a mix of different ethnic backgrounds, who have been on insulin therapy and have a high blood sugar level, as indicated by a test called HbA1c.

If eligible and willing to participate, families will receive support in transitioning to these new technologies, including getting devices like continuous glucose monitors (CGMs). Participants will have their blood sugar levels monitored before and after using the devices, with regular check-ins at the clinic. The study will look at how much time participants spend in a healthy blood sugar range and other health metrics over three and six months. The findings could be crucial in helping healthcare providers and families make better decisions and reduce health disparities in diabetes care for children from underserved communities.

Gender

ALL

Eligibility 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