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

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.

Timeline

Start

2017-11-22

Primary completion

2019-07-22

Completion

2019-07-22

Publications

• Galderisi A, Cohen N, Calhoun P, Kraemer K, Breton M, Weinzimer S, Cengiz E. Effect of Afrezza on Glucose Dynamics During HCL Treatment. Diabetes Care. 2020 Sep;43(9):2146-2152. doi: 10.2337/dc20-0091. Epub 2020 Jul 13.

Drugs

Indications