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

NCT ID: NCT07087340

Last Updated: 2026-02-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-21
• Study Completion Date: 2026-04-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

UBLoop Intervention Group

For a period of approximately 10 hours, study participants will wear an insulin pump and a continuous glucose monitor (CGM), with the UBLoop system controlling insulin delivery based on the CGM readings. The UBLoop system will be operating via an app installed on a smartphone.

Group Type: EXPERIMENTAL

UBLoop System

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).
• Body Mass Index (BMI) ≤18.5 or ≥ 35 kg m2
• Estimated glomerular filtration rate (eGFR) lab value below 30 mL/min/1.73 m2
• Pregnancy or intent to become pregnant during the study.
• Currently breastfeeding or planning to breastfeed.
• Currently uncontrolled seizure disorder.
• Planned surgery during the study duration.
• Have uncontrolled hypertension (systolic BP above or equal to 160 mmHg and/or diastolic BP above or equal to 100 mmHg). If a participant is on anti-hypertensive therapies, doses must be stable for 30 days before screening. For participants with uncontrolled hypertension at the screening visit, antihypertensive medication may be started or adjusted.*
• Personal history of one of the following cardiovascular conditions: acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, or hospitalization due to congestive heart failure (CHF) in the last three months before the screening.
• Conditions that may increase the risk of induced hypoglycemia such as known coronary artery disease, CHF (Have NYHA Functional Classification III or IV CHF), history of any cardiac disorder or arrhythmia, history of cerebrovascular event, hypoglycemia-induced migraine within the past six months, seizure disorder, syncope, adrenal insufficiency, or neurological disease).
• Cystic fibrosis.
• Uncontrolled thyroid disease as judged by the investigator.
• Have an uncontrolled psychiatric condition such as (major depressive disorder, schizophrenia, bipolar disorder, or other serious mood or anxiety disorder, alcohol or drug abuse).
• Treatment with a non-insulin glucose-lowering agent, except metformin, in stable doses in the last three months.
• Participants receiving or have received systemic glucocorticoid therapy within three months before screening (Prednisolone 10mg daily or equivalent >2 weeks) or chronic systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, single intraarticular injection, or inhaled preparations).
• Have current treatment with (or history of, within 3 months before screening) medications that may affect glucose metabolism, as judged by the investigator.
• Current enrolment in another clinical trial, unless approved by the investigator of both studies, and if the clinical trial is a non-interventional registry trial.
• Have evidence of a significant active, uncontrolled medical condition or a history of any medical problem capable of constituting a risk when using the study devices or interfering with the interpretation of data, as judged by the study physician at screening.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DCB Research AG

OTHER

Sponsor Role: collaborator

DexCom, Inc.

INDUSTRY

Sponsor Role: collaborator

mylife Diabetes Care AG

INDUSTRY

Sponsor Role: collaborator

University of Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Markus Laimer, Prof.Dr.med.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinik für Diabetologie, Endokrinologie, Ernährungsmedizin & Metabolismus (UDEM)

Locations

Inselspital, Universitätsspital; Universitätsklinik für Diabetologie, Endokrinologie, Ernährungsmedizin & Metabolismus (UDEM)

Bern, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Kizito Mbata

Role: CONTACT

kizito.mbata@insel.ch

+41 31 664 07 47

Markus Laimer, Prof.Dr.med.

Role: CONTACT

markus.laimer@insel.ch

+41 31 632 40 70

Facility Contacts

Kizito Mbata

Role: primary

kizito.mbata@insel.ch

+41 31 664 07 47

Markus Laimer, Prof.Dr.med.

Role: backup

markus.laimer@insel.ch

+41 31 632 40 70

Other Identifiers

2025-D0056

Identifier Type: -

Identifier Source: org_study_id