Utilizing the Bionic Pancreas in Cystic Fibrosis Related Diabetes
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Description
Insulin therapy, commonly given as multiple daily injection therapy, is the only recommended treatment for Cystic Fibrosis Related Diabetes (CFRD). Traditional therapy for CFRD requires an intense daily effort related to diabetes care on top of the already burdensome management of Cystic Fibrosis. In this study, we will assess the safety and effectiveness of the iLet Bionic Pancreas, an automated insulin delivery system, which uses a continuous glucose monitor (CGM), an insulin pump, and a control formula that activates insulin delivery based on CGM glucose data.
Eligibility and criteria
What to expect
The initial phase of the study will last 13 weeks. Participants will be randomized into two groups. One group will use the iLet Bionic Pancreas and one will continue with their normal insulin delivery methods. There will be 7 visits, many of which can be done virtually, throughout the 13 weeks. During the first phase both groups will have their A1c levels taken via fingerstick, a pregnancy test (if applicable), and be provided the option to participate in sub studies, as well as have the study team review their glucose data.
After the initial 13 weeks, the participants in the group that did not use the iLet will switch to this device and wear it for 13 weeks. Participants in the iLet group will continue to use the device for an additional 13 weeks. In total, participation in the study will last for 26 weeks and will be compensated.
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