RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-07-26
Study Completion:2025-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05849753

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * HbA1C ≥ 8.0% at least twice within the last 12 months before study initiation, upper limit of HbA1C \<14%
  2. * 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
  3. * 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
  4. * History of hypothyroidism on adequate replacement therapy with normal thyroid function will be allowed
  1. * Severe eczema or any other skin condition that would limit availability of healthy skin to wear devices
  2. * Chronic medications/medical conditions that could interfere with diabetes management (ADHD medications allowed)
  3. * Chronic seizures, or severe neurodevelopmental delay
  4. * Current use of hybrid closed-loop, automated insulin delivery system
  5. * Significant mental health disorder that in opinion of the investigator would hinder device use

Contacts and Locations

Study Contact

Nelly Mauras, MD
CONTACT
904-697-3674
Nelly.Mauras@nemours.org
Kelly Hildebrandt, MD
CONTACT
904-697-3674
kelly.hildebrandt@nemours.org

Principal Investigator

Nelly Mauras, MD
PRINCIPAL_INVESTIGATOR
Nemours Children's Health Jacksonville

Study Locations (Sites)

Nemours Children's Health
Jacksonville, Florida, 32207
United States
Nemours Children's Health
Orlando, Florida, 32827
United States

Collaborators and Investigators

Sponsor: Nemours Children's Clinic

  • Nelly Mauras, MD, PRINCIPAL_INVESTIGATOR, Nemours Children's Health Jacksonville

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-26
Study Completion Date2025-05

Study Record Updates

Study Start Date2023-07-26
Study Completion Date2025-05

Terms related to this study

Additional Relevant MeSH Terms

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