Early Investigation of a New Semi-Automated Insulin Delivery System in Type 1 Diabetes: UBLoop-Genesis

Switzerland (ICTRP)

ICTRP Studien-ID
NCT07087340 (ICTRP)

Offizieller Titel (Genehmigt von der Ethikkommission)
Early feasibility evaluation of the UniBE hybrid closed-loop insulin delivery system in Type 1 Diabetes: UBLoop - Genesis (BASEC)

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

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

Untersuchte Krankheit(en)
Type-1-Diabetes (ICTRP)

Untersuchte Intervention
Device: UBLoop System (ICTRP)

Studientyp
Interventional (ICTRP)

Studiendesign
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Device Feasibility. Masking: None (Open Label). (ICTRP)

Ein-/Ausschlusskriterien
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. (ICTRP)

nicht verfügbar

Primäre und sekundäre Endpunkte
Percentage of time with the system functioning in closed-loop mode;Failure rate of the HCL algorithm;Failure rate of the communication with CGM device;Failure rate of the communication with Insulin pump;Failure rate of the user interface (BernSHELL);Failure rate of the web monitoring tool (DigiCARE) (ICTRP)

nicht verfügbar

Registrierungsdatum
nicht verfügbar

Einschluss des ersten Teilnehmers
nicht verfügbar

Sekundäre Sponsoren
DCB Research AG;DexCom, Inc.;mylife Diabetes Care AG (ICTRP)

Weitere Kontakte
Markus Laimer, Prof.Dr.med.Kizito MbataKizito Mbata, kizito.mbata@insel.chkizito.mbata@insel.ch, +41 31 664 07 47+41 31 664 07 47, Universittsklinik fr Diabetologie, Endokrinologie, Ernhrungsmedizin & Metabolismus (UDEM) (ICTRP)

Sekundäre IDs
2025-D0056 (ICTRP)

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar

Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT07087340 (ICTRP)