Early Feasibility Evaluation of the UniBE Hybrid Closed-loop Insulin Delivery System in Type 1 Diabetes: UBLoop-Genesis

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1. 1Since this trial has already been completed and was focused on testing whether the UniBE system's hardware and software actually worked reliably — things like communication failures and how often it stayed in closed-loop mode — has the data been published yet, and what did it show about how dependable the system was?
2. 2Because this was an early feasibility study rather than a phase 2 or 3 efficacy trial, it wasn't primarily designed to prove the system improves blood sugar control — so how does that limit what we can actually conclude about whether it would benefit me compared to a closed-loop system that's already approved?
3. 3The trial measured failure rates in several components, including the CGM link, the insulin pump link, and the user interface called BernSHELL — were there any meaningful failure rates found, and what would those mean for daily safety if someone were using this system?
4. 4Given that this was an early feasibility study that has now completed, is there a follow-up trial planned that tests whether this system actually improves outcomes like time in range, and would that be something worth watching for?
5. 5Since this system includes a web monitoring tool called DigiCARE, what kind of data sharing and remote oversight would be involved, and is that something that fits how I manage my diabetes day to day?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.