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NCT03738852 · ClinicalTrials.gov registry record · Early Phase 1
Mechanisms for Restoration of Hypoglycemia Awareness
A Early Phase 1 study, sponsored by Yale University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 55
- Enrollment target
NCT03738852: Completed Early Phase 1 study, sponsored by Yale University.
NCT03738852 is a Early Phase 1 study that has completed, run by Yale University. The registered enrollment target is 55 participants, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03738852, a Early Phase 1 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 55 participants
- Enrollment target
Study Summary
To assess if using the hypoglycemic clamp and functional magnetic resonance imaging (fMRI) scanning in hypoglycemia unaware and aware T1DM patients and healthy controls have showed distinct differences in patterns of brain responses. In particular, T1DM patients who are aware of hypoglycemia (T1DM-Aware) have greater activity in sensory integration brain regions (e.g. parietal lobe and caudate nucleus) in response to hypoglycemia, whereas hypoglycemia unaware T1DM patients (T1DM-Unaware) show no detectable changes in brain reward regions during hypoglycemia.
Primary Outcome
Regional quantification of brain glucose levels with MRS (CMRgl) will be used to measure group differences.
Interventions
- DRUG Insulin
- DEVICE Continuous Glucose Monitor (CGM)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2018-11-07 |
| Est. Completion | 2023-08-14 |
| Phase | Early Phase 1 |
What the finished NCT03738852 record still lists
NCT03738852 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Insulin is the first listed.
NCT03738852 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03738852 about?
NCT03738852 is a clinical study titled "Mechanisms for Restoration of Hypoglycemia Awareness". To assess if using the hypoglycemic clamp and functional magnetic resonance imaging (fMRI) scanning in hypoglycemia unaware and aware T1DM patients and healthy controls have showed distinct differences in patterns of brain responses. In particular, T1DM patients who are aware of hypoglycemia (T1DM-A...
What is the current status of trial NCT03738852?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 55 participants. The study started on 2018-11-07. Estimated completion is 2023-08-14.
What interventions are being tested in trial NCT03738852?
The interventions under investigation include: Insulin (DRUG), Continuous Glucose Monitor (CGM) (DEVICE).
Who is sponsoring clinical trial NCT03738852?
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 NCT03738852's enrollment target sits among peer trials
55 458th of 2000 higher than 1,537 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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