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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Bern

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

An HbA1C ≥10% .

History of diabetic ketoacidosis (DKA) in the past 12 months.

History of severe hypoglycaemic event (Level 3): defined as seizure or loss of consciousness in the past 12 months.

Current uncontrolled chronic diabetic microvascular complications (neuropathy, retinopathy, renal diabetes disease, and diabetic gastroparesis).

Trial design

Treatments tested in this trial

  • UBLoop System

Treatment groups

6 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of Bern

Lead sponsor

DCB Research AG

Collaborator

DexCom, Inc.

Collaborator

mylife Diabetes Care AG

Collaborator