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RECRUITING
NCT05849753

Breaking Disparities in Access to Advanced Diabetes Technologies in Children With Type 1 Diabetes

Sponsor: Nemours Children's Clinic

View on ClinicalTrials.gov

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

DEVICE

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