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NCT05849753 · ClinicalTrials.gov registry record
Breaking Disparities in Access to Advanced Diabetes Technologies in Children With Type 1 Diabetes
A clinical trial of Diabetes Mellitus, Type 1 and Child, sponsored by Nemours Children's Clinic.
- Recruiting
- Registry status
- 50
- Enrollment target
- 2
- Study locations
NCT05849753 is a study of Diabetes Mellitus, Type 1 and Child that is actively recruiting participants, run by Nemours Children's Clinic. The registered enrollment target is 50 participants, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT05849753, a study of Diabetes Mellitus, Type 1 and Child, is actively recruiting participants, sponsored by Nemours Children's Clinic.
- RECRUITING
- Registry status
- 50 participants
- Enrollment target
- 2
- Study locations
Study 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.
Conditions Studied
Interventions
- DEVICE Advanced artificial pancreas closed-loop technology
Study Locations (2)
Florida
- Nemours Children's Health - Jacksonville
- Nemours Children's Health - Orlando
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2023-07-26 |
| Est. Completion | 2026-12-31 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05849753
The ClinicalTrials.gov registry entry for NCT05849753 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (96% lower). The listed sponsor is Nemours Children's Clinic, which has 108 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Diabetes Mellitus, Type 1 appearing as the primary indexed condition, and to 1 intervention - of which Advanced artificial pancreas closed-loop technology is the first listed.
NCT05849753 reports 2 study locations spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT05849753 about?
NCT05849753 is a clinical study titled "Breaking 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 a...
What is the current status of trial NCT05849753?
This trial is currently recruiting. The enrollment target is 50 participants. The study started on 2023-07-26. Estimated completion is 2026-12-31.
What conditions does trial NCT05849753 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 1, Child, Equipment and Supplies, Delivery of Health Care.
What interventions are being tested in trial NCT05849753?
The interventions under investigation include: Advanced artificial pancreas closed-loop technology (DEVICE).
Who is sponsoring clinical trial NCT05849753?
This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05849753 being conducted?
This trial has 2 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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