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NCT01269008 · ClinicalTrials.gov registry record · Phase 1
Closed Loop System With Pramlintide Versus Exenatide
A Phase 1 study, sponsored by Albert Einstein College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT01269008 is a Phase 1 study that has completed, run by Albert Einstein College of Medicine. The registered enrollment target is 13 participants.
The verdict
NCT01269008, a Phase 1 study, has completed, sponsored by Albert Einstein College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
Post-prandial hyperglycemia occurs despite meticulous carbohydrate counting and rapid acting insulin therapy. Furthermore, this occurs even in the setting of the closed loop system. Currently the algorithm used for calculating the glucose-responsive insulin delivery cannot respond in a timely fashion to the glucose absorption resulting from a meal. In diabetes, there is paradoxical immediate post-prandial hyperglucagonemia that results in immediate post-prandial hyperglycemia. Amylin deficiency and/or dysregulated GLP-1 seems to be the etiology. Pharmacologic replacement of these hormones alleviates immediate post-prandial hyperglycemia in diabetes. With this protocol, the investigators would like to optimize treatment of T1DM by physiologic replacement of hormones in addition to insulin and in the process also optimize the insulin algorithm. This is a paired, randomized, and controlled comparison of pramlintide and insulin versus exenatide and insulin Vs insulin monotherapy using the ePID closed-loop system for insulin delivery. The investigators will stratify the study subjects into the following sub-groups of 5 subjects of 22-30 years old, 4 subjects of 18-21 years old, 4 subjects of 16-18 years old. The investigators would also begin the study with the 21-25 year patient sub-group and then transition to the other sub-groups after evaluating all the safety issues. 22-30 year old ones would be considered as an adult subset, 18-21 year olds would be considered pediatric subset according to the guidelines of FDA's Center for Devices and Radiological Health (CDRH) and 16-18 year olds are considered typical pediatric population. At this time, Spanish-speaking subjects will not be recruited because Medtronic Minimed as yet does not have any literature in Spanish that may used in explaining the study to this group of patients. When in the future Medtronic is able to provide us with the appropriate Spanish literature, the investigators will at that time amend the proto
Interventions
- DEVICE Medtronic ePID 2.0
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2010-12 |
| Est. Completion | 2013-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01269008
The ClinicalTrials.gov registry entry for NCT01269008 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Albert Einstein College of Medicine, which has 175 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Medtronic ePID 2.0 is the first listed.
NCT01269008 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01269008 about?
NCT01269008 is a clinical study titled "Closed Loop System With Pramlintide Versus Exenatide". Post-prandial hyperglycemia occurs despite meticulous carbohydrate counting and rapid acting insulin therapy. Furthermore, this occurs even in the setting of the closed loop system. Currently the algorithm used for calculating the glucose-responsive insulin delivery cannot respond in a timely fashio...
What is the current status of trial NCT01269008?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2010-12. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01269008?
The interventions under investigation include: Medtronic ePID 2.0 (DEVICE).
Who is sponsoring clinical trial NCT01269008?
This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.
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