NCT07087340

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: University of Bern · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Type-1-Diabetes

Interventions

Type	Name	Description
DEVICE	UBLoop System	Participants (people living with Type-1-Diabetes) will attend a study visit where the UBLoop system will manage insulin delivery via an insulin pump, using blood glucose values from a continuous glucose meter (CGM). Specialized staff and a remote monitoring system, which is integrated into the UBLoop system, will oversee the participants. The investigational product comprises (1) the BernSHELL App, communicating with the CGM and the insulin pump, (2) the UBLoop algorithm receiving CGM data, processing the control algorithm, calculating insulin dosing, checking the safety of the calculated insulin injections, and transmitting instructions to the insulin pump via BernSHELL, (3) the UBLoop Cloud providing secure storage, analytics support, and data backup, (4) DigiCare, monitoring the safety of the study participants and the system's execution flow in real time. During the intervention, participants will use the Ypsomed myLife YpsoPump (insulin pump) and the Dexcom G6 or G7 CGM.

Timeline

• Start date: 2026-01-21
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2025-07-28
• Last updated: 2026-02-13

Locations

1 site across 1 country: Switzerland