Health TrialsbyHealthPanel

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

ConditionType-1-Diabetes
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • UBLoop System

    Device

    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.

Treatment groups

6 Participants
are divided into 1 treatment group
Group A: UBLoop Intervention GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of time with the system functioning in closed-loop mode

Time frame
10 hours
2

Failure rate of the HCL algorithm

Time frame
10 hours
3

Failure rate of the communication with CGM device

Time frame
10 hours
4

Failure rate of the communication with Insulin pump

Time frame
10 hours

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Bern

Lead sponsor

DCB Research AG

Collaborator

DexCom, Inc.

Collaborator

mylife Diabetes Care AG

Collaborator

Source ClinicalTrials.gov
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