NCT05849753Recruiting
Breaking Disparities in Access to Advanced Diabetes Technologies in Children With Type 1 Diabetes
Breaking Health Care Disparities in Access to Advanced Diabetes Technologies in Children With Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 20 Jul 2026
Brief summary (registry, in English)
50 children/adolescents (ages 6 to \<18yrs) with T1D in suboptimal control (HbA1c≥8.0%) and lower SES (below 200% poverty line) on insulin therapy (either injections or open-loop pumps) will be recruited at Nemours \~ 1/3 each AA, Hispanic/Latino, non-Hispanic whites. All families that qualify and agree to transition to closed-loop technologies will be recruited to allow data to be gathered before and after use of devices. They will go through the process of approval with the assistance of an insurance navigator in clinic. Those not a CGM will be prescribed one as well. Diabetes care will be 'real life', devices will be prescribed, and care per clinic routine with periodic device downloads. Principal outcome, time-in-range, will be analyzed at 3-months compared to baseline, each participant their own control. Secondary outcomes including HbA1c, other glucose metrics and questionnaires related to use of technology and diabetes distress will be also analyzed. All outcomes will also be collected at 6-months. Results could have important and fast applicability to the field and help better inform decision makers, including payers, clinicians, and patients and families and could serve to decrease health care disparities in this needy population.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 26 Mar 2023
- Start date
- 26 Jul 2023
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- Nemours Children's Clinic
- Diseases
- Type 1 diabetes
- NCT number
- NCT05849753
What you commit to
- Study type: Observational
- Planned participants: 50
- From 26 Jul 2023 to the primary completion date, 30 Nov 2026
- 2 sites 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
- 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
- Significant mental health disorder that in opinion of the investigator would hinder device use
Other
- Current use of hybrid closed-loop, automated insulin delivery system
Who the study is looking for
- 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
Age in the registry: 6 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nemours Children's Health Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Nemours Children's Health Coordinator of this site? Confirm its status | Orlando | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.