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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: Completed Phase 1 study, sponsored by Oregon Health and Science University.
NCT03424044 is a Phase 1 study that has completed, run by Oregon Health and Science University. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Assess the percent of time that the Dexcom G5 or G6 reported sensor glucose values less than 70 mg/dl using Dexcom sensor across all three arms.
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 |
What the finished NCT03424044 record still lists
NCT03424044 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 4 interventions - of which Artificial Pancreas Controller in Dual Hormone Mode is the first listed.
NCT03424044 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03424044's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 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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