What is the purpose of this trial?
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.
The age inclusion criterion is 18-29 years for phase I and 18-50y for phase II. Only recruiting for phase I (18-29) currently.
Ages: 18 - 50 years
Juvenile Diabetes Research Foundation International
Start Date: 10/01/2017
End Date: 02/28/2021
Last Updated: 06/22/2018
Study HIC#: 2000020715