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

NCT05849753 | Recruiting DMC FDA Device

• 1 other identifier: 1980589-3]
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Child; Diabetes Mellitus, Type 1; Delivery of Health Care; Equipment and Supplies

Outcome Measures

Primary Outcomes (1)

• Percent sensor glucose time-in-range

  70-180mg/dL

  3 months

Secondary Outcomes (11)

• HbA1C

  3 months

• Percent sensor glucose time in hypoglycemic range

  3 months

• Perceptions of Benefits & Burden of Closed-Loop Systems

  3 months

• Problem Areas in Diabetes

  3 months

• Technology Attitudes

  3 months

Study Arms (1)

T1DM lower SES

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

Device: Advanced artificial pancreas closed-loop technology

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).

T1DM lower SES

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

A target of 50 children and adolescents (ages 6 to \<18yrs) with T1D in suboptimal control (HbA1c≥8.0%) and of lower SES (below 200% of state-specific poverty line by family size and income), with no other chronic illnesses will be recruited from the Pediatric Endocrine clinics at Nemours Children's Health Clinics in Jacksonville and Orlando, FL. Cohort will be \~ 1/3 each AA, Hispanic/Latino, and non-Hispanic White (NHW).

You may qualify if:

• 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 whites. Asians, Pacific Islanders and other ethnic groups however will not be excluded from participation if other criteria met
• History of hypothyroidism on adequate replacement therapy with normal thyroid function will be allowed

You may not qualify if:

• Severe eczema or any other skin condition that would limit availability of healthy skin to wear devices
• Chronic medications/medical conditions that could interfere with diabetes management (ADHD medications allowed)
• Chronic seizures, or severe neurodevelopmental delay
• Current use of hybrid closed-loop, automated insulin delivery system
• Significant mental health disorder that in opinion of the investigator would hinder device use

Sponsors & Collaborators

• Nemours Children's Clinic: lead
• Jaeb Center for Health Research: collaborator

Study Sites (2)

Nemours Children's Health

Jacksonville, Florida, 32207, United States

RECRUITING

Nemours Children's Health

Orlando, Florida, 32827, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Nelly Mauras, MD

  Nemours Children's Health Jacksonville

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nelly Mauras, MD

CONTACT

904-697-3674; Nelly.Mauras@nemours.org

Kelly Hildebrandt, MD

CONTACT

904-697-3674; kelly.hildebrandt@nemours.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair of Pediatrics for Research/Director of Research, Nemours North FL

Study Record Dates

• First Submitted: March 26, 2023
• First Posted: May 9, 2023
• Study Start: July 26, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

US (2)