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

NCT ID: NCT05849753

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-26
• Study Completion Date: 2026-03-30

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.

Detailed Description

Type 1 diabetes (T1D) has serious complications, yet only ~17% of children achieve an HbA1C goal of <7.5% and in adolescents mean HbA1c remains persistently high at 9.3%. Technology use in children has increased, both insulin pump use and continuous glucose monitors (CGM), offering hope to improve diabetes control and outcomes. There are however, striking socio-economic (SES) and racial/ethnic disparities in these outcomes, with worse metabolic control and much lower use of technology in those of lower SES and racial/ethnic minorities. Reasons are multifactorial, including more limited access to care, insurance challenges, and providers' biases in prescribing these devices, but also related to implicit bias and structural racism towards minority groups. Rates of diabetes complications and ketoacidosis are higher in Black and Latino youth, yet these children are largely under-represented in clinical trials and in the clinical use of FDA-approved modern diabetes technologies. Closed-loop artificial pancreas now allows for the semi-automatic or fully automatic delivery of insulin based on CGM glucose, with potential to further improve glycemic control. The investigators' recent data suggest that patients in ethnic minority groups provided devices through a clinical trial may indeed benefit from this technology with improved time-in-range and HbA1c. Insurance companies, including Medicaid now include these FDA-approved devices in their formulary, yet they continue to be underutilized by these needy families. The investigators believe the overwhelming amount of data support the routine use of closed-loop insulin delivery technology in children. The proposed study will be first to compare use of advanced closed-loop insulin delivery systems specifically focused on children with T1D of lower SES, including racial/ethnic minorities, using patient-centered outcomes while understanding clinical markers of diabetic control. The principal study question is whether these children can benefit from a closed-loop insulin delivery treatment option and improve health care disparities in a 'real life' setting.

Specific Aims:

To investigate in children with type 1 diabetes of lower SES, including AA and Latino racial/ethnic minorities, who are in suboptimal diabetes control, if when they are consistently offered advanced artificial pancreas closed-loop technology, and are better assisted in getting approval and starting these devices clinically:

1. can health care disparities decrease by improving overall diabetes control including time-in-range sensor glucose(70-180mg/dl) (principal) and other metrics of glycemic control including HbA1c at 3 months;

2. can any clinical benefit be sustained for 6 months in a real life setting;

3. can the above treatments improve patient/family reported perceptions of quality of life, including diabetes distress and psychosocial aspects of closed-loop technology? (secondary)

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

T1DM lower SES

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

Advanced artificial pancreas closed-loop technology

Intervention Type: 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).

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).

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jaeb Center for Health Research

OTHER

Sponsor Role: collaborator

Nemours Children's Clinic

OTHER

Sponsor Role: lead

Responsible Party

Nelly Mauras

Vice Chair of Pediatrics for Research/Director of Research, Nemours North FL

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nelly Mauras, MD

Role: PRINCIPAL_INVESTIGATOR

Nemours Children's Health Jacksonville

Locations

Nemours Children's Health

Jacksonville, Florida, United States

Site Status: RECRUITING

Nemours Children's Health

Orlando, Florida, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Nelly Mauras, MD

Role: CONTACT

Nelly.Mauras@nemours.org

904-697-3674

Kelly Hildebrandt, MD

Role: CONTACT

kelly.hildebrandt@nemours.org

904-697-3674

Facility Contacts

Nelly Mauras, MD

Role: primary

nmauras@nemours.org

904-697-3674

Kelly Hildebrandt, MD

Role: backup

kelly.hilldebrandt@nemours.org

904-314-7276

Mauri Carakushansky, MD

Role: primary

mauri.carakusansky@neours.org

407-650-7144

Kelly Hilldebrandt, MD

Role: backup

kelly.hildebrandt@nemours.org

904-314-7276

Other Identifiers

1980589-3]

Identifier Type: -

Identifier Source: org_study_id