Actively Recruiting
Breaking Disparities in Access to Advanced Diabetes Technologies in Children With Type 1 Diabetes
Led by Nemours Children's Clinic · Updated on 2026-02-23
50
Participants Needed
2
Research Sites
179 weeks
Total Duration
On this page
Sponsors
N
Nemours Children's Clinic
Lead Sponsor
J
Jaeb Center for Health Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Breaking Disparities in Access to Advanced Diabetes Technologies in Children With Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of type 1 diabetes for at least 1 year based on clinical signs or positive diabetes autoantibodies and on insulin treatment (injections or open-loop pumps)
- HbA1c of 8.0% or higher at least twice in the past 12 months, with an upper limit below 14%
- Lower socioeconomic status defined as below 200% of the US poverty level by family size and income or exceptional circumstances per investigators
- Approximately one-third African American, one-third Hispanic/Latino, and one-third non-Hispanic white; other ethnic groups allowed if criteria met
- History of hypothyroidism is allowed if on adequate replacement therapy with normal thyroid function
You will not qualify if you...
- Severe eczema or other skin conditions that prevent wearing devices
- Chronic medications or medical conditions that interfere with diabetes management (except ADHD medications)
- Chronic seizures or severe neurodevelopmental delay
- Current use of hybrid closed-loop or automated insulin delivery systems
- Significant mental health disorders that would hinder device use as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Nemours Children's Health
Jacksonville, Florida, United States, 32207
Actively Recruiting
2
Nemours Children's Health
Orlando, Florida, United States, 32827
Not Yet Recruiting
Research Team
N
Nelly Mauras, MD
CONTACT
K
Kelly Hildebrandt, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here