AI-Assisted Remote Insulin Pump Optimization in T1DM

Prior treatment

• History of severe hypoglycemia within the 6 months prior to screening, defined as an event requiring medical assistance (i.e., physician office visit, emergency room visit, or hospitalization), coma, seizure, or hypoglycemia with loss of consciousness.
• Presence of significant acute or chronic complications, hepatorenal disease, or other systemic diseases at screening. Hyperthyroidism or hypothyroidism with unstable thyroid function at the time of screening, defined as thyroid-stimulating hormone outside the normal range with concurrent abnormal free triiodothyronine or free thyroxine levels.
• Prior pancreas or islet cell transplantation.
• Any of the following cardiovascular or cerebrovascular events within 1 year prior to screening: myocardial infarction, heart failure (NYHA Class III/IV), unstable angina, coronary artery bypass grafting, coronary stent implantation, angina pectoris, congestive heart failure, ventricular arrhythmia, transient ischemic attack (TIA), cerebrovascular accident (CVA), or other thromboembolic disease.
• Use of any oral, injectable, or intravenous glucocorticoids within 8 weeks prior to screening, or planned use during the study period.
• Planned elective surgery requiring general anesthesia, or planned dialysis during the study period.
• For women of childbearing potential: pregnancy, lactation, positive pregnancy test at screening, or planned pregnancy during the study period. Women of childbearing potential who are not using an effective method of contraception (e.g., oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) and who do not agree to continue using such effective contraception during the study period will be excluded.
• Current participation in, or treatment with an investigational drug or device within 2 weeks prior to screening (observational studies are permitted).

Other illness

• Unresolved acute complications of diabetes at screening, including diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS), or hyperglycemia with severe circulatory impairment.
• Unresolved adverse skin conditions at the intended device placement site (e.g., psoriasis, dermatitis herpetiformis, rash, staphylococcal infection) at screening.
• Diagnosis of any of the following: malignancy, tuberculosis or other chronic wasting disease, hematological disorder, psychiatric disorder, systemic lupus erythematosus, rheumatoid arthritis, autoimmune hemolytic anemia, or clinically significant malabsorption. Diagnosis of adrenal insufficiency, or current treatment for hyperthyroidism, or planned treatment for hyperthyroidism during the study period.
• History of drug abuse or alcohol abuse.
• Any other condition that, in the investigator's judgment, would make the participant unsuitable for the study, including but not limited to: history of ocular trauma or other confirmed ocular disease causing blurred vision, deafness, eating disorders, celiac disease, or being underweight (Body Mass Index \< 18 kg/m²).

Lab values

• Use of any of the following non-insulin glucose-lowering agents within 8 weeks prior to screening, or planned use during the study period: thiazolidinediones (TZDs), alpha-glucosidase inhibitors, sulfonylureas (SUs), glinides, dipeptidyl peptidase-4 inhibitors (DPP-4i), sodium-glucose cotransporter-2 inhibitors (SGLT2i), or glucagon-like peptide-1 receptor agonists (GLP-1 RAs). Participants currently using any of these agents must undergo a washout period of at least 7 days prior to enrollment.

Other

• Intolerance to subcutaneous infusion sets or adhesive tapes, or presence of edema.

• Clinical diagnosis of T1D, meeting all three of the following criteria:
  • Clinical medical records or a certification document issued by a specialist physician confirming the diagnosis;
  • At least one of the following: age at disease onset \< 15 years; presentation with ketosis or diabetic ketoacidosis (DKA) at onset; no overweight or obesity at onset; highest random C-peptide \< 200 pmol/L;
  • At least one of the following: continuous insulin therapy initiated after diagnosis; positive for any islet autoantibody.
• Age 14 to 65 years, inclusive, male or female.
• HbA1c \< 11.0% at the screening visit.
• At least 3 months of documented T1D duration, and at least 3 months of treatment with either multiple daily insulin injections (MDI) or insulin pump therapy.
• Willing to wear the study device continuously throughout the trial and to use either insulin aspart or insulin lispro.
• Willing to perform at least one fingerstick blood glucose measurement per day.
• Willing to upload data from the study device.
• Willing and able to provide signed informed consent (by the participant and/or legally authorized representative) and to learn basic diabetes management and study device operation.