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NCT03400501 · ClinicalTrials.gov registry record · Early Phase 1
Reducing the Risk of Metabolic Decompensation in Diabetic Adolescents by Supervised School Administration of Insulin
A Early Phase 1 study, sponsored by Yale University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 32
- Enrollment target
NCT03400501: Completed Early Phase 1 study, sponsored by Yale University.
NCT03400501 is a Early Phase 1 study that has completed, run by Yale University. The registered enrollment target is 32 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03400501, a Early Phase 1 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
This is a pilot study to examine and compare the efficacy of supervised injections of long acting insulins degludec and glargine to protect youth with poorly controlled type 1 diabetes (T1D) from development of ketones.
Primary Outcome
Will test the the hypothesis that β-hydroxybutyrate levels will be lower in the morning (≥0.6 mmol/L) of the first day of the school week in subjects receiving I-deg, since the long half-life of I-deg will compensate for missed insulin doses over the weekend/holidays.
Interventions
- DRUG Insulin Glargine
- DRUG Insulin Degludec
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2017-10-01 |
| Est. Completion | 2021-06-07 |
| Phase | Early Phase 1 |
What the finished NCT03400501 record still lists
NCT03400501 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which Insulin Glargine is the first listed.
NCT03400501 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03400501 about?
NCT03400501 is a clinical study titled "Reducing the Risk of Metabolic Decompensation in Diabetic Adolescents by Supervised School Administration of Insulin". This is a pilot study to examine and compare the efficacy of supervised injections of long acting insulins degludec and glargine to protect youth with poorly controlled type 1 diabetes (T1D) from development of ketones.
What is the current status of trial NCT03400501?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 32 participants. The study started on 2017-10-01. Estimated completion is 2021-06-07.
What interventions are being tested in trial NCT03400501?
The interventions under investigation include: Insulin Glargine (DRUG), Insulin Degludec (DRUG).
Who is sponsoring clinical trial NCT03400501?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03400501's enrollment target sits among peer trials
32 775th of 2000 higher than 1,207 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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