Clinical Research Directory
Browse clinical research sites, groups, and studies.
Breaking Disparities in Access to Advanced Diabetes Technologies in Children With Type 1 Diabetes
Sponsor: Nemours Children's Clinic
Summary
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.
Official title: Breaking Health Care Disparities in Access to Advanced Diabetes Technologies in Children With Type 1 Diabetes
Key Details
Gender
All
Age Range
6 Years - 17 Years
Study Type
OBSERVATIONAL
Enrollment
50
Start Date
2023-07-26
Completion Date
2026-12-31
Last Updated
2026-02-23
Healthy Volunteers
No
Interventions
Advanced artificial pancreas closed-loop technology
Study is an observational capture of data in patients that qualify, before and after the use of any FDA-approved closed-loop system of Subject's/Family's choosing that uses a CGM that does not require fingerprick calibrations. Devices prescribed available through their insurance (including Medicaid).
Locations (2)
Nemours Children's Health
Jacksonville, Florida, United States
Nemours Children's Health
Orlando, Florida, United States