Actively Recruiting
Early Feasibility Evaluation of the UniBE Hybrid Closed-loop Insulin Delivery System in Type 1 Diabetes: UBLoop-Genesis
Led by University of Bern · Updated on 2026-02-13
6
Participants Needed
1
Research Sites
14 weeks
Total Duration
On this page
Sponsors
U
University of Bern
Lead Sponsor
D
DCB Research AG
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Early Feasibility Evaluation of the UniBE Hybrid Closed-loop Insulin Delivery System in Type 1 Diabetes: UBLoop-Genesis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Type 1 diabetes for at least one year
- Age between 18 and 65 years old (inclusive)
- Using insulin therapy for at least six months
- Using closed-loop insulin therapy for at least three months
- Willing to suspend any personal continuous glucose monitor during the study
- Willing not to start new non-insulin glucose-lowering medications during the study
- Willingness to understand and follow the study protocol and provide informed consent
You will not qualify if you...
- HbA1C level of 10% or higher
- History of diabetic ketoacidosis in the past 12 months
- History of severe hypoglycemic event (seizure or loss of consciousness) in the past 12 months
- Uncontrolled chronic diabetic microvascular complications
- Body mass index below 18.5 or above 35 kg/m2
- Estimated glomerular filtration rate below 30 mL/min/1.73 m2
- Pregnancy, intent to become pregnant, or breastfeeding
- Uncontrolled seizure disorder
- Planned surgery during the study
- Uncontrolled hypertension (systolic ≥160 mmHg or diastolic ≥100 mmHg)
- Recent cardiovascular events or conditions within past three months
- Conditions increasing hypoglycemia risk such as heart disease, migraines, seizure disorders
- Cystic fibrosis
- Uncontrolled thyroid disease
- Uncontrolled psychiatric conditions
- Recent or current use of certain glucose-lowering or glucocorticoid medications
- Participation in other clinical trials unless approved
- Any significant active or uncontrolled medical condition posing risk or interfering with data interpretation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Inselspital, Universitätsspital; Universitätsklinik für Diabetologie, Endokrinologie, Ernährungsmedizin & Metabolismus (UDEM)
Bern, Switzerland, 3010
Actively Recruiting
Research Team
K
Kizito Mbata
CONTACT
M
Markus Laimer, Prof.Dr.med.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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