RecruitingNCT05849753

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


Sponsor

Nemours Children's Clinic

Enrollment

50 participants

Start Date

Jul 26, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 6 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is working to close the gap in access to advanced diabetes technology — specifically continuous glucose monitors and automated insulin delivery systems — for children from lower-income families living with type 1 diabetes. These technologies can significantly improve blood sugar control but are often out of reach for disadvantaged families. **You may be eligible if...** - Your child has had a type 1 diabetes diagnosis for at least one year - Your child's blood sugar (HbA1c) has been poorly controlled (8% or higher) at least twice in the past year - Your family has lower socioeconomic status (income below 200% of the federal poverty level, or receiving federal assistance) - Your child is using insulin injections or a basic (non-automated) insulin pump **You may NOT be eligible if...** - Your child is already using an automated insulin delivery system or continuous glucose monitor - Your child's HbA1c is 14% or higher - Your child has significant other medical conditions unrelated to diabetes - Your family is unwilling to engage with the digital education components of the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Health

Jacksonville, Florida, United States

Nemours Children's Health

Orlando, Florida, United States

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NCT05849753


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