Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01333514 · ClinicalTrials.gov registry record · Phase 4
Carbohydrate Consumption as a Factor in Aspart Dosing
A Phase 4 study, sponsored by Rush University Medical Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 14
- Enrollment target
NCT01333514: Clinical Trial Phase 4 study, sponsored by Rush University Medical Center.
NCT01333514 is a Phase 4 study that was terminated before completion, run by Rush University Medical Center. The registered enrollment target is 14 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01333514, a Phase 4 study, was terminated before completion, sponsored by Rush University Medical Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 14 participants
- Enrollment target
Study Summary
Good sugar control in postoperative hospitalized patient has been shown to improve wound healing and infection rates. However, sugar control is difficult to achieve and suboptimal use of insulin is thought to be a contributory factor. Though it is known that generally the consumption of carbohydrates alone raises the blood sugar, the usual practice of dosing meal-time insulin is based on the fraction of the total meal-tray eaten which includes proteins, fats and carbohydrates. This leads to an overestimation of insulin required for a patient who consumes a portion of mainly proteins and fats on their trays or an underestimation for those eating mainly the carbohydrates on their tray. Low sugars or high blood sugars can follow respectively. Hypothesis: The purpose of this study is to see if dosing meal-time insulin based on grams of carbohydrates consumed will result in better sugar control compared to the usual practice of dosing meal-time insulin based on percent of total meal consumed in hospitalized patients.
Primary Outcome
Will determine if the probability of hypoglycemia in each arm; calculation details \[i.e. "Experimental Event Rate (EER) = probability of outcome occurring in experimental group = a/(a+b)"\]
Interventions
- DRUG aspart
- DRUG aspart- Insulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2011-04 |
| Est. Completion | 2012-12 |
| Phase | Phase 4 |
Why NCT01333514 stopped before completion
NCT01333514 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which aspart is the first listed.
NCT01333514 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01333514 about?
NCT01333514 is a clinical study titled "Carbohydrate Consumption as a Factor in Aspart Dosing". Good sugar control in postoperative hospitalized patient has been shown to improve wound healing and infection rates. However, sugar control is difficult to achieve and suboptimal use of insulin is thought to be a contributory factor. Though it is known that generally the consumption of carbohydrate...
What is the current status of trial NCT01333514?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 14 participants. The study started on 2011-04. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01333514?
The interventions under investigation include: aspart (DRUG), aspart- Insulin (DRUG).
Who is sponsoring clinical trial NCT01333514?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01333514's enrollment target sits among peer trials
14 1901st of 2000 higher than 91 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02523092 · 14 participants · Phase 4
Use of CXCL9 as a Biomarker of Acthar Efficacy
- NCT04263285 · 14 participants · NA
Treatment of Depression Post-SCI
- NCT04743271 · 14 participants · NA
Food and Circadian Timing
- NCT05065671 · 14 participants · Phase 1
Microbiome Derived Metabolism and Pharmacokinetics
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia