MedTrace Logo

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

NCT03234491 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-05-25

No results posted yet for this 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.

Conditions

  • Post-Prandial Hyperglycemia
  • Post-Prandial Hypoglycemia

Interventions

DEVICE

DiAS

Diabetes Assistant (DiAS) hybrid closed loop system.

DRUG

Afrezza low dose

Afrezza inhaled insulin low dose.

DRUG

Afrezza high dose

Afrezza inhaled insulin high dose.

Sponsors & Collaborators

  • Yale University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-22
Primary Completion
2019-07-22
Completion
2019-07-22
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03234491 on ClinicalTrials.gov