Recruiting

Observational Study

Sponsor:

Nemours Children's Clinic

Code:

NCT05849753

Conditions

Diabetes Mellitus, Type 1

Child

Delivery of Health Care

Equipment and Supplies

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Interventions

Advanced artificial pancreas closed-loop technology

Study Details

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

Diabetes Mellitus, Type 1

Child

Delivery of Health Care

Equipment and Supplies

Study ID

NCT05849753

Start date

Jul 26, 2023

Status verified date

Feb, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

T1DM lower SES

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

Interventions

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).

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Nelly Mauras, MD

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

Kelly Hildebrandt, MD

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

Locations

Nemours Children's Health

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

Nelly Mauras, MD

904-697-3674nmauras@nemours.org

Kelly Hildebrandt, MD

904-314-7276kelly.hilldebrandt@nemours.org

Principal Investigator:

Nelly Mauras, M.D

More Information

Sponsor

Nemours Children's Clinic

Last update posted

Jul 20, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nemours Children's Clinic on 2026-07-20.