Follows children with type 1 diabetes getting advanced automated insulin devices
Follows children with type 1 diabetes and limited income as they start closed-loop devices.
Plain-language title generated from the registry record
Registry title: Breaking Disparities in Access to Advanced Diabetes Technologies in Children With Type 1 Diabetes
Key facts
- Where
- Jacksonville and Orlando, United StatesSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 17 years old?
Source: NCT05849753, who can take part
Where in United States
- Nemours Children's HealthJacksonville, United StatesTaking people
- Nemours Children's HealthOrlando, United StatesNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Nemours Children's Clinic
- Trial code
- NCT05849753
- Record updated
- 20 July 2026
- Original description
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.Read full original descriptionShow less
Breaking Health Care Disparities in Access to Advanced Diabetes Technologies in Children With Type 1 Diabetes
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.
Inclusion: 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: 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; Current use of hybrid closed-loop, automated insulin delivery system.