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NCT01401634 · ClinicalTrials.gov registry record · Phase 1
Oral Hydration for Mild to Moderate Hyperglycemia in the Emergency Department
A Phase 1 study, sponsored by University of Southern California.
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
NCT01401634: Completed Phase 1 study, sponsored by University of Southern California.
NCT01401634 is a Phase 1 study that has completed, run by University of Southern California. The registered enrollment target is 80 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01401634, a Phase 1 study, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
Study Summary
Diabetes and high blood sugar are extremely common among patients presenting to US Emergency Departments. Intravenous fluids with or without insulin are often used to treat these patients. However, simple, low-cost interventions, such oral hydration have not been studied in this context. Oral rehydration may be better than no therapy at all, which is often what these patients receive in the first few hours when presenting to busy, overcrowded Emergency Department (ED) with long wait times, or in resource-poor environments such as developing countries. The investigators propose a study to see if oral hydration for adult patients presenting to the ED with high blood sugar i.e. finger-stick (FS) values between 250 and 500 mg/dL can help lower blood sugar at the same rate as intravenous fluids. Half the patients will be given intravenous fluids per our department protocol, while the other half of the patients will be given 2 liters of water to drink over a 1-hour period. Both groups will have their blood sugar measured every 30 mins for 2 hours. The investigators will analyze the data to determine if there is a statistically significant difference in blood sugar between the two groups within 2 hours.
Primary Outcome
Patients will have their blood sugar checked every 30 minutes for 2 hours
Interventions
- OTHER Intravenous normal saline
- OTHER Oral water
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2011-01 |
| Phase | Phase 1 |
What the finished NCT01401634 record still lists
NCT01401634 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher).
The record links to 0 conditions, and to 2 interventions - of which Intravenous normal saline is the first listed.
NCT01401634 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01401634 about?
NCT01401634 is a clinical study titled "Oral Hydration for Mild to Moderate Hyperglycemia in the Emergency Department". Diabetes and high blood sugar are extremely common among patients presenting to US Emergency Departments. Intravenous fluids with or without insulin are often used to treat these patients. However, simple, low-cost interventions, such oral hydration have not been studied in this context. Oral rehydr...
What is the current status of trial NCT01401634?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2011-01.
What interventions are being tested in trial NCT01401634?
The interventions under investigation include: Intravenous normal saline (OTHER), Oral water (OTHER).
Who is sponsoring clinical trial NCT01401634?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01401634's enrollment target sits among peer trials
80 672nd of 2000 higher than 1,305 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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