Breaking Disparities in Access to Advanced Diabetes Technologies in Children With Type 1 Diabetes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-17
SponsorNemours Children's Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Advanced artificial pancreas closed-loop technology
DeviceStudy 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).
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: T1DM lower SES1 intervention
Trial outcomes
Primary outcomes
1
Percent sensor glucose time-in-range
70-180mg/dL
Time frame
3 monthsSecondary outcomes
1
HbA1C
percent
Time frame
3 months2
Percent sensor glucose time in hypoglycemic range
less than 54 mg/dL
Time frame
3 months3
Perceptions of Benefits & Burden of Closed-Loop Systems
Psychosocial questionnaire (Scale: 35-175); higher score reflects better outcome
Time frame
3 months4
Problem Areas in Diabetes
Psychosocial questionnaire (Scale: 0-80); lower score reflects better outcome
Time frame
3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Nemours Children's Clinic
Lead sponsor
Jaeb Center for Health Research
Collaborator
Source ClinicalTrials.gov