Breaking Health Care Disparities in Access to Advanced Diabetes Technologies in Children With Type 1 Diabetes
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.
Description
Type 1 diabetes (T1D) has serious complications, yet only \~17% of children achieve an HbA1C goal of \<7.5% and in adolescents mean HbA1c remains persistently high at 9.3%. Technology use in children has increased, both insulin pump use and continuous glucose monitors (CGM), offering hope to improve diabetes control and outcomes. There are however, striking socio-economic (SES) and racial/ethnic disparities in these outcomes, with worse metabolic control and much lower use of technology in those of lower SES and racial/ethnic minorities. Reasons are multifactorial, including more limited acces…
Eligibility
- Age range
- 6–17 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceAdvanced 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 HealthJacksonville, Florida
- Nemours Children's HealthOrlando, Florida