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

NCT07087340 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-02-13

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • DCB Research AG

    collaborator OTHER

  • DexCom, Inc.

    collaborator INDUSTRY

  • mylife Diabetes Care AG

    collaborator INDUSTRY

  • University of Bern

    lead OTHER

Principal Investigators

  • Markus Laimer, Prof.Dr.med. · Universitätsklinik für Diabetologie, Endokrinologie, Ernährungsmedizin & Metabolismus (UDEM)

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-21
Primary Completion
2026-04-30
Completion
2026-04-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07087340 on ClinicalTrials.gov