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

Prior treatment

• 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.
• 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).

Other illness

• 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).
• Currently uncontrolled seizure disorder.
• 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).
• 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).
• 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.

Lab values

• An HbA1C ≥10% .
• Estimated glomerular filtration rate (eGFR) lab value below 30 mL/min/1.73 m2
• Treatment with a non-insulin glucose-lowering agent, except metformin, in stable doses in the last three months.
• Have current treatment with (or history of, within 3 months before screening) medications that may affect glucose metabolism, as judged by the investigator.

Other

• Body Mass Index (BMI) ≤18.5 or ≥ 35 kg m2
• Pregnancy or intent to become pregnant during the study.
• Currently breastfeeding or planning to breastfeed.
• Cystic fibrosis.
• 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.

• 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.