Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by Yale University.
NCT03234491 is a Phase 1 study that has completed, run by Yale University. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Continuous glucose monitoring (CGM) using Yellow Springs Instrument (YSI) will be used to measure blood glucose (mg/dl). Data will be collected for a maximum 4 hours following each meal.
Interventions
- DEVICE DiAS
- DRUG Afrezza low dose
- DRUG Afrezza high dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2017-11-22 |
| Est. Completion | 2019-07-22 |
| Phase | Phase 1 |
What the finished NCT03234491 record still lists
NCT03234491 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 3 interventions - of which DiAS is the first listed.
NCT03234491 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03234491's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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
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
- NCT01889381 · 15 participants · Phase 2
Human Craniomaxillofacial Allotransplantation
- NCT02530073 · 15 participants · NA
Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH
- NCT02535936 · 15 participants · NA
Cortical Plasticity in Spastic Diplegia After Selective Dorsal Rhizotomy
- NCT02918474 · 15 participants · NA
Decision Making Tool in Supporting Decision Making in Contralateral Prophylactic Mastectomy in Patients With Newly Diagnosed Breast Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI