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NCT05006040 · ClinicalTrials.gov registry record · Early Phase 1
HCL Single Arm Pilot Study in Treatment of Hyperglycemia of Pediatric ALL
A Early Phase 1 study, sponsored by University of Colorado, Denver.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 1
- Enrollment target
NCT05006040: Clinical Trial Early Phase 1 study, sponsored by University of Colorado, Denver.
NCT05006040 is a Early Phase 1 study that was terminated before completion, run by University of Colorado, Denver. The registered enrollment target is 1 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05006040, a Early Phase 1 study, was terminated before completion, sponsored by University of Colorado, Denver.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
The overall objective of this pilot study is to determine the safety and feasibility of a hybrid closed-loop insulin delivery system for children and young adults with high risk acute lymphoblastic leukemia, during the induction chemotherapy phase while they are exposed to steroids and asparaginase that cause hyperglycemia.
Primary Outcome
The primary outcome measures for this study will be the safety of HCL insulin delivery by hypoglycemia exposure. One of the primary endpoints is CGM Time in hypoglycemia (defined as blood glucose \< 70 mg/dL).
Interventions
- DEVICE Hybrid Closed Loop System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2022-05-12 |
| Est. Completion | 2023-08-01 |
| Phase | Early Phase 1 |
Why NCT05006040 stopped before completion
NCT05006040 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Hybrid Closed Loop System is the first listed.
NCT05006040 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05006040 about?
NCT05006040 is a clinical study titled "HCL Single Arm Pilot Study in Treatment of Hyperglycemia of Pediatric ALL". The overall objective of this pilot study is to determine the safety and feasibility of a hybrid closed-loop insulin delivery system for children and young adults with high risk acute lymphoblastic leukemia, during the induction chemotherapy phase while they are exposed to steroids and asparaginase ...
What is the current status of trial NCT05006040?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 1 participants. The study started on 2022-05-12. Estimated completion is 2023-08-01.
What interventions are being tested in trial NCT05006040?
The interventions under investigation include: Hybrid Closed Loop System (DEVICE).
Who is sponsoring clinical trial NCT05006040?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05006040's enrollment target sits among peer trials
1 1985th of 2000 the lowest of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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