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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
6 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Injections, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Secondary outcomes including HbA1c, other glucose metrics and questionnaires related to use of technology and diabetes distress will be also analyzed."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether switching to a system that automatically adjusts insulin helps children ages 6 to 17 with type 1 diabetes. It is for children from lower-income families whose blood sugar is not well controlled. Families will get help with insurance approval, and the study will track blood sugar and device use over 6 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 6 to 17 years old.
  • Have had type 1 diabetes for at least 1 year and use insulin shots or a pump that does not automatically adjust insulin.
  • Have an HbA1c of at least 8% on two or more tests in the past year, with an upper limit below 14%. HbA1c measures average blood sugar over about 3 months.
  • Meet the study’s low-income rule, based on family size and income, or have special financial needs accepted by the study team.
  • Be willing to switch to a system that automatically adjusts insulin.
  • Children of all racial and ethnic groups may join if they meet the other rules.
  • Children with an underactive thyroid may join if treatment keeps their thyroid levels normal.

Who can't join

  • Have severe eczema or another skin problem that leaves too little healthy skin to wear the devices.
  • Have a long-term health condition or take medicines that could interfere with diabetes care. ADHD medicines are allowed.
  • Have ongoing seizures or severe delays in brain development and related skills.
  • Already use a system that automatically adjusts insulin, including a hybrid closed-loop system.
  • Have a serious mental health condition that the study team thinks would make device use difficult.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (2)

FL