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NCT03234491 · ClinicalTrials.gov registry record · Phase 1

Improving Post-Prandial Blood Glucose Control With Afrezza During Closed-Loop Therapy

A Phase 1 study, sponsored by Yale University.

Completed
Registry status
Phase 1
Development phase
15
Enrollment target

NCT03234491 is a Phase 1 study that has completed, run by Yale University. The registered enrollment target is 15 participants.

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The verdict

NCT03234491, a Phase 1 study, has completed, sponsored by Yale University.

COMPLETED
Registry status
Phase 1
Development phase
15 participants
Enrollment target

Study Summary

The study will be conducted in two phases; an in-patient meal study phase (Phase I) and an outpatient home study (Phase II). The two phase study design is chosen to enhance safety by testing the Afrezza Closed-Loop (CL) system in controlled in-clinic setting under study staff supervision before it could be investigated at the outpatient home setting. Phase II will not begin without the establishment of safety in Phase I.

Interventions

  • DEVICE DiAS
  • DRUG Afrezza low dose
  • DRUG Afrezza high dose

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2017-11-22
Est. Completion 2019-07-22
Phase Phase 1

Sponsor

Yale University

1,492 total trials

What the Registry Record Tells You About NCT03234491

The ClinicalTrials.gov registry entry for NCT03234491 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which DiAS is the first listed.

NCT03234491 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03234491 about?

NCT03234491 is a clinical study titled "Improving Post-Prandial Blood Glucose Control With Afrezza During Closed-Loop Therapy". The study will be conducted in two phases; an in-patient meal study phase (Phase I) and an outpatient home study (Phase II). The two phase study design is chosen to enhance safety by testing the Afrezza Closed-Loop (CL) system in controlled in-clinic setting under study staff supervision before it c...

What is the current status of trial NCT03234491?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2017-11-22. Estimated completion is 2019-07-22.

What interventions are being tested in trial NCT03234491?

The interventions under investigation include: DiAS (DEVICE), Afrezza low dose (DRUG), Afrezza high dose (DRUG).

Who is sponsoring clinical trial NCT03234491?

This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.