Early Feasibility Evaluation of the UniBE Hybrid Closed-loop Insulin Delivery System in Type 1 Diabetes: UBLoop - Genesis
The study is investigating the early feasibility of a novel algorithm for a hybrid closed-loop (HCL) insulin delivery system in adult patients with Type 1 diabetes. Participants will attend a study visit where the UBLoop system on a smartphone will manage insulin delivery via an insulin pump, using blood glucose values from a continuous glucose meter. Specialized staff and a remote monitoring system, which is integrated into the UBLoop system, will oversee the participants.
• T1D diagnosis for at least one year.
• Aged between 18 and 65 years old (inclusive).
• Currently using insulin for at least six months.
• Currently using closed-loop insulin therapy for at least three months.
• Willingness to suspend any personal CGM for the duration of the pilot study once the study CGM is in place.
• Willingness not to start any new non-insulin glucose-lowering agent during the study (including metformin/biguanides, incretin agonists \[GIP/GLP-1RAs or GLP-1RAs\], pramlintide, DPP-4 inhibitors, sulfonylureas, Sodium-glucose cotransporter-2 inhibitors \[SGLT2 inhibitors\], and nutraceuticals).
• Understanding and willingness to follow the protocol and signed informed consent.