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NCT04878120 · ClinicalTrials.gov registry record · NA
Hybrid Closed-Loop Control With Smart Prandial Insulin Dosing in Type 1 Diabetes
A NA study, sponsored by University of Virginia.
- Completed
- Registry status
- NA
- Development phase
- 25
- Enrollment target
NCT04878120: Completed NA study, sponsored by University of Virginia.
NCT04878120 is a NA study that has completed, run by University of Virginia. The registered enrollment target is 25 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04878120, a NA study, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the safety and feasibility of a smart bolus calculator that adjusts insulin dosing for meals according to real-time insulin sensitivity (SI) in adolescents with type 1 diabetes (T1D) using a hybrid closed loop (HCL) system during an active week of diabetes camp.
Primary Outcome
LBGI computed from CGM collected in the four hours following the dinner meal. LBGI is a metric quantifying the risk for hypoglycemia (the higher the LBGI, the higher the exposure to/risk of hypoglycemia), calculated based on the following two steps: 1. Transforming each CGM reading in the time-series of length N into a hypoglycemia risk score (rL(i), i=1,...,N) by applying the following transformation: rL(i) = 10 x (1.509 x (log(CGM(i))\^1.084 - 5.381))\^2, if CGM(i) \<=112.5 mg/dL; rL(i)
Interventions
- DEVICE Standard HCL System
- DEVICE HCL System with Smart Bolus Calculator
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2021-05-14 |
| Est. Completion | 2022-06-28 |
| Phase | NA |
What the finished NCT04878120 record still lists
NCT04878120 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard HCL System is the first listed.
NCT04878120 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04878120 about?
NCT04878120 is a clinical study titled "Hybrid Closed-Loop Control With Smart Prandial Insulin Dosing in Type 1 Diabetes". The objective of this study is to evaluate the safety and feasibility of a smart bolus calculator that adjusts insulin dosing for meals according to real-time insulin sensitivity (SI) in adolescents with type 1 diabetes (T1D) using a hybrid closed loop (HCL) system during an active week of diabetes ...
What is the current status of trial NCT04878120?
This trial is currently completed. It is a NA study. The enrollment target is 25 participants. The study started on 2021-05-14. Estimated completion is 2022-06-28.
What interventions are being tested in trial NCT04878120?
The interventions under investigation include: Standard HCL System (DEVICE), HCL System with Smart Bolus Calculator (DEVICE).
Who is sponsoring clinical trial NCT04878120?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04878120's enrollment target sits among peer trials
25 1712th of 2000 higher than 265 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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