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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 1; Child; Delivery of Health Care; Equipment and Supplies
• Intervention / Treatment: Device: Advanced artificial pancreas closed-loop technology

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)

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Nelly Mauras, MD; Phone Number: 904-697-3674; Email: Nelly.Mauras@nemours.org
• Study Contact Backup: Name: Kelly Hildebrandt, MD; Phone Number: 904-697-3674; Email: kelly.hildebrandt@nemours.org

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Recruiting
      • Nemours Children's Health
      • Contact: Nelly Mauras, MD; Phone Number: 904-697-3674; Email: nmauras@nemours.org
      • Principal Investigator: Nelly Mauras, M.D
      • Contact: Kelly Hildebrandt, MD; Phone Number: 904-314-7276; Email: kelly.hilldebrandt@nemours.org
    • Orlando, Florida, United States, 32827
      • Not yet recruiting
      • Nemours Children's Health
      • Contact: Mauri Carakushansky, MD; Phone Number: 407-650-7144; Email: mauri.carakusansky@neours.org
      • Contact: Kelly Hilldebrandt, MD; Phone Number: 904-314-7276; Email: kelly.hildebrandt@nemours.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent sensor glucose time-in-range	70-180mg/dL	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1C	percent	3 months
Percent sensor glucose time in hypoglycemic range	less than 54 mg/dL	3 months
Perceptions of Benefits & Burden of Closed-Loop Systems	Psychosocial questionnaire (Scale: 35-175); higher score reflects better outcome	3 months
Problem Areas in Diabetes	Psychosocial questionnaire (Scale: 0-80); lower score reflects better outcome	3 months
Technology Attitudes	Psychosocial questionnaire related to diabetes technology (Scale: 5-25); higher score reflects better outcome	3 months
Percent sensor glucose time-in-range	70-180mg/dL	6 months
HbA1C	percent	6 months
Percent sensor glucose time in hypoglycemic range	less than 54 mg/dL	6 months
Perceptions of Benefits & Burden of Closed-Loop Systems	Psychosocial questionnaire (Scale: 35-175); higher score reflects better outcome	6 months
Problem Areas in Diabetes	Psychosocial questionnaire (Scale: 0-80); lower score reflects better outcome	6 months
Technology Attitudes	Psychosocial questionnaire relating to diabetes technology (Scale: 5-25); higher score reflects better outcome	6 months

Collaborators and Investigators

• Sponsor: Nemours Children's Clinic
• Collaborators: Jaeb Center for Health Research
• Investigators: Principal Investigator: Nelly Mauras, MD, Nemours Children's Health Jacksonville

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 26, 2023
• First Submitted That Met QC Criteria: May 7, 2023
• First Posted (Actual): May 9, 2023

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1; Gastrointestinal Agents; Pancrelipase
• Other Study ID Numbers: 1980589-3]

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No