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

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Nemours Children's Clinic
Study ID
NCT05849753
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Advanced artificial pancreas closed-loop technology — DEVICE
    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).

Study Details

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.

Key Dates

Start date
Jul 26, 2023
Status verified
Feb 2026
Primary completion
May 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: T1DM lower SES
    Type 1 diabetes of lower SES, including AA and Latino racial/ethnic minorities, who are in suboptimal diabetes control.

Primary Outcome Measure

Percent sensor glucose time-in-range [ Time Frame: 3 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Nemours Children's HealthJacksonvilleFlorida32207
Nelly Mauras, MD
[email protected]
904-697-3674
Kelly Hildebrandt, MD
[email protected]
904-314-7276
Nelly Mauras, M.D (PRINCIPAL_INVESTIGATOR)
Nemours Children's HealthOrlandoFlorida32827
Mauri Carakushansky, MD
[email protected]
407-650-7144
Kelly Hilldebrandt, MD
[email protected]
904-314-7276

Find similar trials in Jacksonville, FL

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Nemours Children's Health· Jacksonville, FLNemours Children's Health· Orlando, FL

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