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NCT03424044 · ClinicalTrials.gov registry record · Phase 1
Three Way Crossover Closed Loop Study With Xeris Glucagon
A Phase 1 study, sponsored by Oregon Health and Science University.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT03424044 is a Phase 1 study that has completed, run by Oregon Health and Science University. The registered enrollment target is 23 participants.
The verdict
NCT03424044, a Phase 1 study, has completed, sponsored by Oregon Health and Science University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
Closed-loop systems are an emerging technology that automate hormone delivery. They are quickly paving the way to revolutionize the treatment of type 1 diabetes. Several categories have emerged: dual-hormone (insulin and glucagon) closed-loop systems and closed-loop systems with insulin only, one variety of which is the low glucose suspend safety feature now available from Medtronic (MiniMed640G with SmartGuard). The study described within this protocol is designed to test the efficacy of a new closed-loop algorithm for managing blood glucose in people with type 1 diabetes before and after exercise. The new algorithm will have 3 modes: a single hormone insulin only mode, a dual-hormone insulin and glucagon mode and an insulin only mode with predictive low glucose suspend, all with an exercise detection algorithm. The purpose of this study is to determine whether a dual hormone AP using a stable investigational glucagon with an exercise detection algorithm outperforms both single hormone AP and a low glucose suspend algorithm.
Interventions
- DEVICE Artificial Pancreas Controller in Dual Hormone Mode
- DEVICE Artificial Pancreas Controller in Single Hormone Mode
- DEVICE Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode
- DRUG XeriSol glucagon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2018-03-29 |
| Est. Completion | 2019-05-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03424044
The ClinicalTrials.gov registry entry for NCT03424044 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oregon Health and Science University, which has 546 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Artificial Pancreas Controller in Dual Hormone Mode is the first listed.
NCT03424044 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03424044 about?
NCT03424044 is a clinical study titled "Three Way Crossover Closed Loop Study With Xeris Glucagon". Closed-loop systems are an emerging technology that automate hormone delivery. They are quickly paving the way to revolutionize the treatment of type 1 diabetes. Several categories have emerged: dual-hormone (insulin and glucagon) closed-loop systems and closed-loop systems with insulin only, one va...
What is the current status of trial NCT03424044?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2018-03-29. Estimated completion is 2019-05-17.
What interventions are being tested in trial NCT03424044?
The interventions under investigation include: Artificial Pancreas Controller in Dual Hormone Mode (DEVICE), Artificial Pancreas Controller in Single Hormone Mode (DEVICE), Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode (DEVICE), XeriSol glucagon (DRUG).
Who is sponsoring clinical trial NCT03424044?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
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