iLet (Closed-loop System) for Treating Diabetes Requiring Exogenous Insulin
March 1, 2016 | Technology Forecasts
Note: The following ratings and comments reflect the opinions and consensus of an expert panel convened by ECRI Institute to review information on this topic.
Anticipated Utilization: 4(Expected to be used by 60% to 80% of patients)
The U.S. Food and Drug Administration (FDA) and a few independent investment research firms estimate there are 350,000 to 515,000 insulin pump users in the United States. We expect a portion of these pump users will want to use a closed-loop system (CLS) such as the iLet (Bionic Pancreas Team), should FDA approve it, due to increased convenience and improved blood sugar regulation. If these improvements are substantial for the iLet system, additional patients not currently using an insulin pump might also elect to use the technology.
Estimated Adoption Status: 1 (Early adoption expected in 2+ years)
The Bionic Pancreas Team plans to conduct human factors studies and clinical trials on the iLet in mid-2016. Therefore, FDA approval would be...