UniBE UBLoop hybrid closed‑loop insulin delivery system (UBLoop‑Genesis) for adults with type 1 diabetes

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

We will test if the UBLoop hybrid closed‑loop system can manage insulin delivery for adults with type 1 diabetes using a smartphone app, an insulin pump, and a continuous glucose monitor.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 6 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Bern (Academic / other)
• Locations: 1 site (Bern)
• Trial ID: NCT07087340 on ClinicalTrials.gov

What this trial studies

This is an early feasibility test of a new algorithm that runs the UBLoop hybrid closed‑loop insulin delivery system in adults with type 1 diabetes. During a supervised visit the UBLoop app on a smartphone will control insulin delivery via an insulin pump using glucose values from a continuous glucose monitor. Specialized staff and an integrated remote monitoring system will oversee participants while the system is active. Participants must meet eligibility requirements such as prior closed‑loop experience and willingness to use the study CGM and suspend their personal CGM for the pilot.

Who should consider this trial

Good fit: Adults 18–65 years old with type 1 diabetes for at least one year who have used insulin for six months and have at least three months' experience with closed‑loop therapy and who agree to use the study CGM are ideal candidates.

Not a fit: Patients with very high HbA1c (≥10%), recent diabetic ketoacidosis or severe hypoglycaemia within the past 12 months, uncontrolled diabetic complications, or those unwilling to pause their personal CGM or use the study devices are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, UBLoop could automate insulin adjustments to increase time in target glucose range and reduce hypoglycemia for adults with type 1 diabetes.

How similar studies have performed: Other hybrid closed‑loop systems have consistently improved time‑in‑range and reduced hypoglycemia in prior studies, though the UBLoop algorithm itself is a novel early‑feasibility test.

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.

Where this trial is running

Bern

• Inselspital, Universitätsspital; Universitätsklinik für Diabetologie, Endokrinologie, Ernährungsmedizin & Metabolismus (UDEM) — Bern, Switzerland (Recruiting)

Study contacts

• Principal investigator: Markus Laimer, Prof.Dr.med. — Universitätsklinik für Diabetologie, Endokrinologie, Ernährungsmedizin & Metabolismus (UDEM)
• Study coordinator: Kizito Mbata

Conditions Type-1-Diabetes; Automated insulin delivery; Artificial pancreas