Improving access to advanced diabetes technology for children with Type 1 Diabetes
Breaking Health Care Disparities in Access to Advanced Diabetes Technologies in Children With Type 1 Diabetes
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 type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 6 Years to 17 Years |
| Sex | All |
| Sponsor | Nemours Children's Clinic Academic / other |
| Locations | 2 sites (Jacksonville, Florida and 1 other locations) |
| Trial ID | NCT05849753 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown success in improving diabetes outcomes with similar technology interventions, particularly among underrepresented groups.
Eligibility criteria
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 this trial is running
Jacksonville, Florida and 1 other locations
- Nemours Children's Health — Jacksonville, Florida, United States (Recruiting)
- Nemours Children's Health — Orlando, Florida, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Nelly Mauras, MD — Nemours Children's Health Jacksonville
- Study coordinator: Nelly Mauras, MD
- Email: Nelly.Mauras@nemours.org
- Phone: 904-697-3674
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.